A.09.03_Solicitation_Amendment_Conformed.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: MICAH STURGEON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011025523-0001

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this Solicitation Amendment is to do the follow ing:

1. Provide answ ers to offerors' questions.

2. Update to CLINs 0001 AB, AD, 1001 Ab, AD, 2001 AB, AD, 3001 AB, AD, and 4001 AB, AD-see summary of changes

3. Update to CLINs 0001 AC, AD, 1001 AC, AD, 2001 AC, AD, 3001 AC, AD, and 4001 AC, AD-see summary of changes

4. Update to the Statement of Objectives-changes "INFL A/B RSV" to "INFL A/B"

5. No more questions w ill be entertained.

Offerors shall acknow ledge this amendment by filling and completing blocks 8 and 15A-C and return w ith offer. Offerors shall still complete original 1449 along w ith all required documents as set forth in solicitation and this amendment (if applicable).

1. CONTRACT ID CODE PAGE OF PAGES

1 21

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 13-Sep-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0018Q0039

X 9B. DATED (SEE ITEM 11)

05-Sep-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

13-Sep-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0018Q0039

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

QUESTIONS AND ANSWERS

SOLICITATION W81K0018Q0039

PCR ANALYZERS AND REAGENTS COST PER TEST

QUESTIONS AND ANSWERS

1. How many number of units are requested?

See Statement of Objectives, paragraph, “Equipment/Reagent Requirements‐Bacteriology Laboratory”, subparagraph, “The analyzer should‐“, first bullet.

2. Does the bid assume all new instruments?

The instruments do not need to be replaced with new units as long as the current units are functioning.

3. Will all Flu A/B testing run in combination with RSV testing as a multiplex assay & no straight Flu A/B testing should be quoted?

Updated Statement of Objectives and CLINs 0001 AB, AD, 1001 AB, AD, 2001 AB, AD, 3001 AB, AD, 4001 AB, and AD, have changed description from “Infl A/B + RSV” to reflect “Infl A/B”.

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

SUBCLIN 0001AB

The CLIN description has changed from Infl A/B +RSV to Infl A/B.

The CLIN extended description has changed from:

Infl A/B and RSV Specific Reagents

To:

Infl A/B Specific Reagents

SUBCLIN 0001AC

The pricing detail quantity has decreased by 2,619.00 from 2,835.00 to 216.00.

SUBCLIN 0001AD

The CLIN description has changed from Infl A/B + RSV Ctrl to Infl A/B Ctrl.

Ancillary Items: Liat Infl A/B + RSV Ctrl

Ancillary Items: Liat Infl A/B Ctrl

The pricing detail quantity has decreased by 3,784.00 from 4,000.00 to 216.00.

SUBCLIN 1001AB

SUBCLIN 1001AC

SUBCLIN 1001AD

SUBCLIN 2001AB

SUBCLIN 2001AC

SUBCLIN 2001AD

SUBCLIN 3001AB

SUBCLIN 3001AC

SUBCLIN 3001AD

SUBCLIN 4001AB

SUBCLIN 4001AC

SUBCLIN 4001AD

The pricing detail quantity has decreased by 3,784.00 from 4,000.00 to 216.00.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for SUBCLIN 0001AC has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

FOB: Destination

W81NWY

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 0001AD has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 1001AC has been changed from:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 1001AD has been changed from:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 2001AC has been changed from:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 2001AD has been changed from:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 3001AC has been changed from:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 3001AD has been changed from:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 4001AC has been changed from:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following Delivery Schedule item for SUBCLIN 4001AD has been changed from:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

1. Scope

1. The Contractor shall provide molecular testing reagents and point-of-care, CLIA-waiver testing analyzers for the rapid (25 minutes or less to result) PCR to detect Influenza A/B combination and Strep A nucleic acid for clinical diagnosis. These analyzers and tests are used to support the mission of the

Department of Pathology and Area Laboratory Services (DPALS) Microbiology Labs at the San Antonio Military Medical Center (SAMMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

a. All supplies and warranties outlined in this Statement of Objectives (SOO) must be supplied and serviced through a single Contractor (to whom the contract is awarded, to include any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor).

b. All supplies and work performed in connected with warranties must preserve the US Food and Drug Administration (FDA) approved status of the assays and instrumentation used.

2. Period of Performance:

Correlation/Validation Period: 1 October 2018-31 October 2018 Base Period: 1 October 2018 – 30 September 2019 (CLIN 0001 and subCLINs) Option 1: 1 October 2019 – 30 September 2020 (CLIN 1001 and subCLINs) Option 2: 1 October 2020 – 30 September 2021 (CLIN 2001 and subCLINs) Option 3: 1 October 2021 – 30 September 2022 (CLIN 3001 and subCLINs) Option 4: 1 October 2022 – 30 September 2023 (CLIN 4001 and subCLINs)

3. Equipment/Reagent Requirements – Bacteriology Laboratory

1. The Contractor must provide the following at a minimum for Microbiology Laboratory operations at the main hospital located at SAMMC and surrounding area clinics:

a. The analyzer should:

o Be FDA-approved, CLIA-waived, point-of-care analyzers and company willing to supply analyzers on a reagent rental basis to support the assays listed below.

o Plug into standard 120V outlet and be provided with individually dedicated electrical cord o Individual analyzers must fit into a foot print no larger than 12 inches x 6 inches and have a maximum height of 18 inches o Must be able to report results of test within 25 minutes of starting test run o Analyzer must be able to scan barcodes and be compatible with 39 and 128 barcode types.

o Turnaround time (TAT) less than 25 minutes and hands-on time less than 5 minutes o Ability to scan barcodes generated in-house o Real time PCR multiplex based technology o Ability to link into CHCS (LIS) for direct reporting

b. The reagents should:

o Reagent capability to multiplex an Influenza A/B assay in one run within FY2019 o All reagents must be in one assay tube/cartridge in isolated segments o Same platform also test for Streptococcus group A (S. pyogenes) with a documented accuracy and sensitivity >95% o Sample source compatible with nasopharyngeal or throat swabs in Universal Transfer

Medium (UTM) o The Contractor must provide all reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section.

o Reagents/consumables must meet the requirements of the 24/7 SAMMC mission, workload, and test menu (outlined in Tables 1 and 2).

o The Contractor to warrant that all supplied items are free of manufacturer defects.

o The Contractor shall repair / replace any unsatisfactory items at vendor’s expense.

o Requested consumables shall be shipped to the point of use, see paragraph 6 below, as stated during the base year of the contract when orders are needed. Items shall be shipped so that they arrive on the 1st business day of each stated month.

o All items are to have a minimum 6-month shelf-life from date of receipt.

c. Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost.

d. The Contractor shall sequester lots of test reagents where possible.

e. The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials.

Deliveries of required items must be in monthly drop shipments or as called in by the COR or

ACOR.

f. Routine orders must arrive no later than five days from the requested date of delivery, excluding federal holidays and weekends. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed ten (10) working days.

g. Contractor shall be able to provide overnight shipping for emergency orders for arrival within 24 hours of the order being placed.

Table 1. Mandatory Tests o Strep A Rapid Reagent o Strep A Control o Infl A/B Combination Rapid Reagent o Infl A/B Control

Expected volumes are as follows for the Microbiology Laboratory, across Fort Sam Houston. These quantities apply to all option years:

Test Annual Volume o Strep A 8500 o Infl A/B 12000

5. Service and Maintenance

1. The Contractor must meet the following service, and maintenance requirements for all testing locations at SAMMC (except where specifically noted otherwise):

The Contractor shall provide direct customer service and support during the hours of 0700 to 1800 central standard time excluding weekends and holidays. This includes, but is not limited to, hotline telephone service (provided in English) and have on-call emergency repair during business hours, to assist operators in correcting equipment problems.

Any repairs, upgrades, to include software, and repairs will be at the Contract expenses under the warranty except in the case of neglect or improper use of analyzer.

6. Delivery

1. All reagents must be available for delivery within one business day of contract award date. Delivery shall be to the following addresses as requested by each location:

a. San Antonio Military Medical Center (Infl A/B & Strep A) Department of Pathology Bacteriology Laboratory

3551 Roger Brooke Drive Fort Sam Houston, TX 78234

b. Jennifer M. Moreno Clinic (Infl A/B & Strep A) Bldg. #1179 Garden Avenue Fort Sam Houston, TX 78234

c. Taylor Burke Health Clinic (Infl A/B & Strep A) 5026, Camp Bullis Rd San Antonio, TX 78257

d. Westover Medical Home (Infl A/B & Strep A) 10010 Rogers Crossing San Antonio, TX 78251

e. Schertz Medical Home (Infl A/B & Strep A)

6051 FM3009

Schertz, TX 78154

The Point of Contact (POC) for all deliveries:

NCOIC or Supervisor, Microbiology Laboratory Department of Pathology San Antonio Military Medical Center Tel: (210) 539-9827

- Supplies shall be sent in a drop shipment at the first of each month unless altered or requested otherwise by the government purchaser.

7. Other Considerations

1. The Contractor must provide paper and electronic copies of material safety data sheets (MSDSs) for each reagent item delivered under this contract (as appropriate).

2. Method validation/verification will be conducted in accordance with procedures outlined in the Department of Pathology policies and standard operating procedures and as required by the CLIA and/or the College of American Pathologists (CAP) and to the ultimate satisfaction of the acting Immunology medical director.

3. The Contractor shall provide a qualified Technical Service Representative (TSR), who possesses a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®), to provide technical assistance for the method validation/verification studies. The assigned TSR will be responsible for the entire method validation to the standards of the acting medical director. Additional TSRs may be brought in to assist in method validations/verifications.

4. All necessary data for validations/verification of all assays above will be completed within 30 days of analyzer and component installation and functionality

Appendix A Department of Defense Health Information Privacy

Introduction

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160, 162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Clause shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304, and 164.501.

(b) The Contractor shall not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor shall use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Clause. These mitigation actions will include as a minimum those listed in the TMA Breach Notification Standard Operating Procedure (SOP), which is available at: http://www.tricare.mil/tmaprivacy/breach.cfm

(f) The Contractor shall report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor shall report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware.

(h) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor shall ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor shall provide access, at the request of the Government, and in the time and manner reasonably designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor shall make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR

164.526 at the request of the Government, and in the time and manner reasonably designated by the Government.

(l) The Contractor shall make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor, on behalf of the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner reasonably designated by the Government or the Secretary, for purposes of the Secretary determining the Government’s compliance with the Privacy Rule.

(m) The Contractor shall document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor shall provide to the Government or an Individual, in time and manner reasonably designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Clause, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, the HIPAA Security Rule, DoD 6025.18-R or DoD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Clause, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Clause, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor’s permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DoD 6025.18-R, DoD 8580.02- R, Privacy Rule or Security Rule means the section currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the “Effect of Termination” provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DoD 6025.18-R, DoD 8580.02-R, the HIPAA Privacy Rule or the HIPAA Security Rule.

Appendix B Information Assurance Standards

1. General Security Requirements.

a. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Army data, to ensure the confidentiality, integrity, and availability of Army data. As a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow:

b. Health Insurance Portability and Accountability Act (HIPAA). Health Insurance Portability and Accountability Act of 1996 (HIPAA) Requirement. The HIPAA standard contract language is mandatory whenever a business associate, (i.e., outside person or agency) creates, receives, maintains, or transmits electronic protected health information (PHI) on behalf of a covered entity. This contract or agreement requires the business associate to:

c. Implement administrative, physical, and technical safeguards that will protect the confidentiality, integrity, and availability of the PHI

d. Ensure all agents or subcontractors to whom the business associate provides PHI will also implement reasonable and appropriate safeguards to protect the information.

e. Report all security incidents.

f. Additional guidance can be found in DoD 8580.02 –R, Health Information Security Regulation.

2. Personnel Security

a. The contractor shall comply with Army Regulation 25–2, "Information Assurance” (IA), Army Regulation 25–1, “Army Knowledge Management and Information Technology,” and " DoD Health Information Privacy Regulation."

b. Contractor shall comply with the following requirements:

(1) Follow the Army guidelines for submittal of Information Technology (IT) security background checks and ensure all contractor personnel are designated as IT-I, IT-II, or IT-III where their duties meet the criteria of the position sensitivity designations. Contact the <type in Activity’s name> for guidance on the appropriate IT levels for personnel on the contract.

(2) Initiate, maintain, and document personnel security investigations appropriate to the individual's responsibilities and required access to MEDCOM Sensitive Information (SI).

(3) Immediately report to the <type in Activity’s name> and deny access to any automated information system (AIS), network, or MEDCOM SI information if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate Army representative for security reasons.

(4) Ensure that all contractor personnel receive information assurance (IA) training before being granted access to Army AISs/networks, and/or MEDCOM SI information.

3. Electronic Security

a. Contractor Information Systems (IS)/networks that are involved in the operation of systems in support of the Army’s Health System shall operate in accordance with controlling laws, regulations, and Army policy.

b. Certification & Accreditation (C&A) requirements apply to all Army and contractor's IS/networks that receive process, display, store or transmit Army information. The contractor shall comply with the C&A process for safeguarding SI. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network.

c. Accreditation is the formal approval by the Army to operate the contractor's IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections; and with appropriate level of protection for the specified period.

d. The contractor shall comply with C&A requirements, as specified by the Army that meet appropriate Army Information Assurance requirements. The C&A requirements shall be met before the contractor's system is authorized to access Army data or interconnect with any Army IS/network that receives, processes, stores, displays or transmits Army data. The contractor shall initiate the C&A process by providing the Contracting Officer Representative, within 60 days following contract award, the required documentation necessary to receive an Approval to Operate (ATO). The contractor shall make their IS/networks available for testing, and initiate the C&A testing four months (120 days) in advance of accessing Army data or interconnecting with Army IS/networks. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the C&A process. They include, but are not limited to:

(1) Attending and supporting C&A meetings with the Army

(2) Supporting/conducting the vulnerability mitigation process

(3) Supporting the C&A Team during system security testing

e. Contractors must confirm that their IS/networks are locked down prior to initiating testing.

f. Conformation of system lock down shall be agreed upon during the definition of the C&A boundary and be signed and documented as part of the Department of Defense Information Assurance Certification and Accreditation Process (DIACAP).

g. Locking down the system means that there shall be no changes made to the configuration of the system (within the C&A boundary) during the C&A process

h. Any re-configuration or change in the system during the C&A testing process will require a re-base-lining of the system and documentation of system changes. Some changes will necessitate a pause in work depending on the severity and impact of change and determined by the COR in conjunction with the IA representative.

i. Vulnerabilities that have been identified by the Army as "must-fix" issues during C&A process must be mitigated according to the timeline identified by the Army Representative. C&A Checklists are provided for complying Army C&A requirements.

j. A request for a waiver to the C&A requirements may be submitted for temporary testing and other usual circumstances. A waiver request must be submitted, in writing, to the Designated Approving Authority (DAA). The request must include mitigation strategies that ensure adequate protection measures and security controls are in place (for example: air gapping a testing network).

k. Information Assurance Vulnerability Management (IAVM). The contractor shall implement an information assurance vulnerability management program. The Army IAVM program provides electronic security protections against known threats and vulnerabilities. The IAVM program requires the registration of AIS system assets, which then allows for the timely dissemination of critical vulnerability information. It also assists in the documentation and tracking of compliance, providing increased electronic security to MEDCOM systems. As part of the program, the contractor shall provide a primary and secondary point of contact for IAVM compliance reporting. The contactor shall thoroughly test all mitigations for the vulnerability, and upon applying the mitigation to the system, report compliance to the MEDCOM IA Operations POC. Receipt and compliance messages to MEDCOM shall occur within the stipulated time window, as stated in the vulnerability message.

l. Guidance regarding the requirement for IAVM is contained in the Army Regulation 25–2, "Information Assurance” and Army Regulation 25–1, “Army Knowledge Management and Information Technology.” An asset is defined as any hardware device, such as a router, firewall, server, or an operating system image accessed by more than one user. The “MEDCOM IASO list server is the primary means to disseminate IAVAs, Information Assurance Vulnerability Bulletins (IAVBs), and Information Assurance Technical Advisories down to the System Administrator (SA) and applicable personnel throughout the chain of command. Requests to be added to the IASO list server should be sent to medcom.ia@amedd.army.mil

m. The contractor shall maintain any development environments in accordance with MEDCOM Information Assurance (IA) best practices and operational requirements. During product development for the Army, the contractor shall ensure that all IA mitigation strategies have been applied to the development environment prior to any Army data being loaded onto any assets or software for testing or delivery.

n. IA mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the Army shall be in compliance with all known applicable Army Computer Emergency Response Team (ACERT) Alert, Bulletin, and Technical Advisory Notices published during the past 36 months.

o. Disposing of Electronic Media. Contractors shall follow the Army standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, in accordance with Army Regulation 25–2, "Information Assurance” and Army Best Business Practices (BBP), “Reuse of Computer Hard Drives.”

p. Ports Protocols and Services. Contractors shall follow all current Army standards and requirements for acceptable Ports, Protocols, and Services. Any requests for exception to using the current Army Ports, Protocols, and Services standards requires an request for exception sent through the Program Manager to the DAA.

q. Public Key Infrastructure and Encryption. Contractors shall follow the Army standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication. Where interoperable PKI is required for the exchange of unclassified information between the Army and its contractors and contractors, industry partners shall obtain all necessary certificates.

Contractors must turn over to the Army all encryption keys for deployed systems, backdoor algorithms, and procedures for their use in remote support. The Contractor must provide a written report detailing all of the above, prior to task order expiration, regardless of modifications or extensions.

4. Information Systems (IS)/Networks Physical Security.

a. The contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Army Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with Army regulations. In addition, the contractor will support a Physical Security Audit performed by the Army of the contractor's internal information management infrastructure. The MHS Physical Security Audit Matrix is available at:

http://www.tricare.osd.mil/tmis_new/Policy/PSA_Matrix_%20012304%200930%20clean%20version.xls.

b. The contractor shall correct any deficiencies identified by the Army of the contractor's physical security posture through contract modification. New Army policies will be posted to the following website:

http://www.apd.army.mil/

c. The contractor shall ensure that data which contains PHI is continuously protected from unauthorized access, use, modification, or disclosure. The contractor shall comply with all previously stated requirements for HIPAA, Personnel Security, Electronic Security, and Physical Security.

(End of Summary of Changes)