N6264520R0074 Released.pdf

SEE ADDENDUM

(No Collect Calls)

N6264520R0074 20-Aug-2020

b. TELEPHONE NUMBER

301-619-9331

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 21 Aug 2020

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

N626459. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

LORRI J. LOVELAND

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE N68470 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

U.S. PACOM ASBBC

CAMP FOSTER BLDG 968

111 FUTENMA BARA

GINOWAN CITY OKINAWA 901-2202

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$22,000,000

NAICS:

811219

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

X EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

Section SF 1449 - CONTINUATION SHEET

ADMINISTRATIVE INFORMATION

***NOTE: PROPOSALS ARE NOT BEING REQUESTED AS A RESULT OF THIS SOLICITATION***

In accordance with the Naval Marine Corps Acquisition Regulation Supplement (NMCARS) 5232.903, Responsibilities: For Prompt Payment Act purposes, this contract is subject to the 7 calendar day constructive acceptance period.

NOTE: THIS IS A SEVERABLE SERVICE TASK ORDER AND SPECIAL REPORTING REQUIREMENTS

EXIST UNDER 10 USC 2410a AND IN ACCORDANCE WITH FAR 32.703-3(b).

The point of contact for administrative concerns at Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD 21702 is Timothy Edmondson (301)-619-8895, Timothy.W.Edmondson.civ@mail.mil

CONTRACTOR SUPPORT

Notice: Navy Use of Support Contractor for Contract Closeout Functions Naval Medical Logistics Command (NMLC) uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C. § 47). The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information. NMLC has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity. By signature of the resultant contract, the offeror and its subcontractors consent to access of their business confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Preventive Maintenance of Procleix Panther

Nucleic Acid Test System Analyzer Equipment Pacific Command Armed Services Blood Bank Center

U. S. Naval Hospital Okinawa

1.0 BACKGROUND

PACOM Armed Services Blood Bank Center is one of two DOD blood donor testing laboratories. PACOM ASBBC is mandated to screen donated blood in order to produce FDA-licensed blood products for the Indo-Pacific region. The Procleix Panther analyzer is an FDA mailto:Timothy.W.Edmondson.civ@mail.mil cleared and approved platform for testing HIV RNA, HCV RNA, HBV DNA, and West Nile Virus RNA utilizing Nucleic Acid Testing. The analyzer requires annual onsite maintenance not available from Biomed resources within USNH Okinawa. The following Performance Work Statement (PWS) details the effort that must be undertaken to support the continuous operation and maintenance of the analyzer.

2.0 GENERAL SCOPE OF WORK

The contractor shall provide telephone technical support, onsite emergency maintenance and onsite preventive maintenance (PM) services for the PROCLEIX PANTHER Nucleic Acid Test system (detail as follows). The contractor shall provide qualified technicians; Original Equipment Manufacturer (OEM) replacement parts; perform system calibrations; and provide all supervision, equipment, supplies and transportation for technicians to maintain the equipment.

3.0 MANUFACTURER: GRIFOLS DIAGNOSTIC SOLUTIONS

MODEL NAME: PROCLEIX PANTHER SYSTEM

ECN: 127682

ANALYZER SN: 000000000300115137

DATE OF COMMERCIAL WARRANTY EXPIRATION: 8/21/2020

4.0 DETAILED WORK REQUIREMENTS

The contractor shall provide the following support.

4.1 PREVENTIVE MAINTENANCE

Preventive maintenance shall be performed every six (6) months. The contractor shall provide one (1) qualified technician to PACOM ASBBC in Okinawa, Japan to perform preventive maintenance. The duration of each trip shall take about three (3) days. The preventive maintenance shall include:

4.2. Thorough check up

4.3. Preventive maintenance shall be done according to the OEM Preventative Maintenance Checklist for the PROCLEIX PANTHER System to include external decontamination, inspection of internal modules, checking for leaks or damage, internal decontamination, vacuum pump inspection, pipettor cleaning and calibration, fluidics inspection, luminometer inspection, UPS battery checks, and replacement of parts as needed.

4.4. The contractor shall file all preventive maintenance checklists completed on the PROCLEIX PANTHER System for all preventive maintenance, remedial repairs or emergency repairs and ensure the PM checklist comments/corrective action comments are detailed, completed, and signed by contractor’s technician and by Contracting Officer’s Representative

(COR).

The Contractor shall develop, within two weeks after award, a Preventive Maintenance schedule that lists the dates and items for those Preventive Maintenances.

5.0 TELEPHONE TECHNICAL SUPPORT

Telephone support shall be available from 0700 to 1600 Japan Standard Time, Monday to Friday. The Contractor shall provide telephone support for troubleshooting instrumentation and reagents through the customer support center. The contractor shall also provide technical support beyond office hour via email. The contractor shall create a record of service calls to allow consolidated reporting of all services activities.

Based on past history, there will be approximately sixty (60) trouble shooting enquiries annually.

The total inquiry time annually is approximately thirty (30) hours.

6.0 UNSCHEDULED MAINTENANCE CALLS

The Contractor shall provide unscheduled maintenance services. Coordination shall be managed by the specialist, who are trained and certified by Grifols to ensure that on site work is completed to U. S. standards and accepted by the Government. A qualified technician should be dispatched within seven (7) working days for any unscheduled maintenance.

Based on past history, there will be approximately two (2) trips annually. The total working time annually is approximately thirty-two (32) hours.

7.0 REPLACEMENT/REPAIR PARTS

The Contractor shall furnish only Original Equipment Manufacturer (OEM) parts to effect all replacements or repairs. The Contractor shall bear all cost associated with obtaining the parts.

The Contractor shall have available or access to all parts necessary for the accomplishment of the service within the time frames set for repairs. All parts installed shall become the property of the Government and the contractor shall dispose the replaced parts properly.

8.0 MAINTENANCE RECORD

The Contractor shall furnish a signed System Maintenance Record written in English to the donor center and hospital upon completion of each maintenance (preventive and corrective) service and for each service call placed. The COR shall countersign the report to certify that services were rendered. The Contractor shall maintain a copy on file and shall submit one copy to the COR for verification immediately following the services. An additional copy of the maintenance record shall be attached to the monthly invoice.

As a minimum, the following information shall be included on each System Maintenance Record:

a. time and date the Contractor was notified.

b. contract number, time and date the Contractor’s maintenance personnel arrived, including the name(s) of each of the Contractor’s employees present.

c. type, model and serial of the equipment.

d. description of the services requested or problem, and of the services actually performed by the Contractor.

e. time spent for repairs.

f. list of parts, which the Contractor replaced, including part number and serial number of each part.

g. list of software, which the Contractor repaired, replaced or upgraded including software version and the serial number of software item. (Contractor shall inform COR of software upgrades prior to installation.)

h. time and date the Contractor returned the system to the Government in operating condition.

i. signature of COR (if services are completed during normal duty hours).

j. signature lines of Contractor and designated government representative.

9.0 TRAVEL AND ACCOMODATION

The contractor shall be responsible for all travel and travel related costs (lodging, airfare, per diem, etc.). Travel and accommodations shall be arranged by the contractor.

10.0 CONTRACTOR’S RESPONSIBILITIES

The Contractor shall provide a point of contact and phone number(s) to which requests for services may be made e.g. trouble desk, answering machine or pager system.

In all instances where Government property or equipment is damaged by the Contractor’s employees, a full report of the facts and the extent of the damage shall be submitted to the COR within 24 hours following the occurrence. The COR shall then forward the report to the Contracting Officer within 24 hours of receipt.

The Contractor shall provide a one week advance notification to the COR before performing any quarterly scheduled preventive maintenance.

11.0 CONTRACTOR’S PERSONNEL

The Contractor shall furnish sufficient qualified technicians who have been trained and certified by the OEM Grifols and/or an equivalent independent service organization-training program that is approved by Grifols. Formal training background shall include, as a minimum, performance of preventive and corrective maintenance on the equipment, with a thorough working knowledge of each system’s hardware and software. The contractor shall provide a list of qualified service personnel to the COR and shall keep him/her updated in the event there is any change.

All technicians shall wear an identification tag that identifies them by name and identifies the Contractor’s name. The tag shall be printed in English and shall be visible at all times while performing services at the US Naval Hospital.

12.0 GOVERNMENT RESPONSIBILITIES

Government personnel will not perform maintenance or attempt repairs to the equipment while the equipment is covered under this maintenance contract.

The Government will permit the Contractor access to the equipment to be maintained and provide ample workspace for the maintenance.

The Contracting Officer will furnish to the Contractor the names of the COR(s) who are authorized to place service calls. Any service rendered by the Contractor without approval of one of the CORs will be at the Contractor’s own expense and the Government will not pay for the service.

The government will issue all required base passes to Contractor personnel at no cost to the Contractor. The contractor must submit any required complete paperwork for base passed with sufficient time for appoval.

13.0 PERIOD OF PERFORMANCE

Period of Performance (PoP): Base Period: 22 August 2020 – 21 August 2021 Option Period 1: 22 August 2021 – 21 August 2022 Option Period 2: 22 August 2022 – 21 August 2023 Option Period 3: 22 August 2023 – 21 August 2024 Option Period 4: 22 August 2024 – 21 August 2025

14.0 PLACE OF PERFORMANCE

PACOM ASBBC Bldg 968 Camp Foster, Okinawa, Japan

15.0 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Performance Objective

Performa nce Standard

Acceptable Quality Level

Monitoring Method/Performance Assessment

PWS

Reference

Medical equipment essential to the healthcare delivery mission is properly maintained ensuring a safe environment of care for patients and staff alike.

Preventive maintenance for all medical equipment under this contract is completed on or before the scheduled date.

95% of all periodic, preventive maintenance is performed within 30 days of the due date.

100% of all periodic, preventive maintenance is performed within 60 days of due date.

Contractor service reports, DMLSS data sampling by COR, and random physical spot checks by BMET personnel.

2, 4,5,6 and 7

Accurate and timely submission of information critical for effective program management and contractor performance evaluation.

Copy of each System Maintenance Report submitted with monthly invoice.

100% completion of service reports related to equipment under contract.

COR shall monitor date of receipt and completeness of service reports.

Response time for corrective maintenance calls.

Contractor on-site within seven

(7) days.

Telephone

Contractor shall be compliant 95% of the time for both telephone and on-site

COR shall review log of calls and verify response times via DMLSS documentation.

4, 5 and 6 support available 0700 – 1600 M – F, Japan Standard Time. Email support after hours.

responses.

Equipment critical to healthcare delivery is operational and available for use as required.

All Medical Equipment under this contract shall be fully functional.

Contractor shall guarantee an overall operational time for all equipment under this contract at or above 95%, based on a 6 month rolling average.

COR shall review DMLSS data for compliance.

2, 3, 4, 5 and 6

Equipment post-service event status

Upon completion of each preventive maintenance visit and each corrective maintenance visit, field service personnel must submit a signed service report to the

COR.

Contractor shall be compliant 95% of the time for providing signed service report to

COR.

COR shall review DMLSS data, service log and service reports for compliance.

15.0 Compliance with Applicable Laws: Contractor shall be

knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of business.

15.1. Physical Security. The Contractor shall use commercially reasonable efforts to safeguard all Government property provided for Contractor use. The Contractor shall designate an individual and alternate(s) to receipt and account for Government-furnished facilities and equipment.

15.2. Performance Evaluation Meetings. The Contractor shall meet with the KO/COR or other government personnel (as required) at least quarterly, at such times as are mutually agreed to by the parties.

15.3. Government Right to Change Standard Operating Procedures. The

Government reserves the right to establish and/or change Standard Operating Procedures which shall be binding on the Contractor, i.e., work order procedures, emergency and fire procedures, security procedures and power failures, upon reasonable advance notice to Contractor.

15.4. Site Visits. The Contractor, or representative having authority to bind the

Contractor, shall be required to visit the site at least semi-annually and meet with KO and/or COR as required to discuss and develop mutual understanding relative to safety precautions, and other contractual requirements. This requirement can be recommended to be cancelled at the discretion of the KO and/or COR. The Government reserves the right to schedule meetings to discuss or resolve issues/problems as it deems to be critical, at no additional cost to the government. All such visits or meetings shall be scheduled at mutually agreed upon times by the parties.

BUSINESS ASSOCIATE AGREEMENT

BUSINESS ASSOCIATE AGREEMENT

PRIVACY AND SECURITY OF PROTECTED HEALTH INFORMATION

Introduction

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Business Associate 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 Business Associate 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.

HITECH Act shall mean the Health Information Technology for Economic and Clinical Health Act included in the American Recovery and Reinvestment Act of 2009.

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 Business Associate 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 Incident will have the same meaning as the term “security incident” in 45 CFR 164.304, limited to the information created or received by Business Associate from or on behalf of Covered Entity.

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 Business Associate 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 Business Associate shall use appropriate safeguards to maintain the privacy of the Protected Health Information and to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The HIPAA Security administrative, physical, and technical safeguards in 45 CFR 164.308, 164.310, and 164.312, and the requirements for policies and procedures and documentation in 45 CFR 164.316 shall apply to Business Associate. The additional requirements of Title XIII of the HITECH Act that relate to the security and that are made applicable with respect to covered entities shall also be applicable to Business Associate. The Business Associate 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 Business Associate shall, at their own expense, take action to mitigate, to the extent practicable, any harmful effect that is known to the Business Associate of a use or disclosure of Protected Health Information by the Business Associate 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 Business Associate shall report to the Government any security incident involving protected health information of which it becomes aware.

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

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

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

(j) The Business Associate 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 Business Associate 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 Business Associate 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 Business Associate, 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 Business Associate 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.

http://www.tricare.mil/tmaprivacy/breach.cfm

(n) The Business Associate 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 Business Associate 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. The additional requirements of Title XIII of the HITECH Act that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to Business Associate.

Specific Use and Disclosure Provisions

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

(b) Except as otherwise limited in this Clause, the Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that disclosures are required by law, or the Business Associate 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 Business Associate 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 Business Associate 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) Business Associate 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 Business Associate of Privacy Practices and Restrictions

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

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

(c) The Government shall notify the Business Associate 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 Business Associate 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 Business Associate as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Business Associate of this clause, may subject the Business Associate 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 Business Associate shall return or destroy all Protected Health Information received from the Government, or created or received by the Business Associate on behalf of the Government. This provision shall apply to Protected Health Information that agents of the Business Associate may come in contact. The Business Associate shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Business Associate determines that returning or destroying the Protected Health Information is infeasible, the Business Associate shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Business Associate that return or destruction of Protected Health Information is infeasible, the Business Associate 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 Business Associate 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.

COR

Contracting Officer’s Representative (COR):

Contracting Officer’s Representative (COR): The Contracting Officer's duly authorized representative, the COR, will perform inspection and acceptance of services to be provided.

For the purposes of this clause, the following individual is the authorized representative of the Contracting Officer:

Name of COR: Ms. Mitsuko Urasaki COR Email Address: mitsuko.urasaki.ln@mail.mil

ECMRA

CONTRACTOR MANPOWER REPORTING LANGUAGE FOR CONTRACT STATEMENT OF

WORK/PERFORMANCE WORK STATEMENTS and Related Background Information

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the activities listed above via a secure data collection site.

The contractor is required to completely fill in all required data fields using the following web address:

https://doncmra.nmci.navy.mil.

Reporting inputs will be for the labor executed during the period of performance during each Governmental fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than Oct 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www/ecmra.mil .

CONTRACT ADMIN PLAN

CONTRACT ADMINISTRATION PLAN (CAP)

1. Definitions.

1.1 Alternate Contracting Officer’s Representative (ACOR). In the absence of the Contracting Officer’s Representative (COR), the Government official appointed in writing by the Contracting Officer who functions as the technical representative of the Contracting Officer for a specific contract, for a specified period of time.

1.2 Department of Health Administration (DHA). The Department of the

Navy command responsible for all Navy medicine healthcare initiatives.

1.3 Commanding Officer. The senior Officer that has ultimate responsibility for the operation of the local activity.

1.4 Contracting Officer. The Government official at the Naval Medical

Logistics Command with the actual authority to enter into, administer, and/or terminate contracts and make related determinations and findings on the behalf of the Government.

1.5 Contracting Officer’s Representative (COR). The Government official appointed in writing by the Contracting Officer who functions as the technical representative of the Contracting Officer under the contract. For Indefinite Delivery and Indefinite Quantity contracts, CORs will be appointed for each task order in addition to an overall contract COR.

1.6 Contractor. The organization identified as the contractor/offeror on the

Standard Form 1449 and its employees who are providing services under the contract.

1.7. Defense Contract Audit Agency (DCAA). The Government office responsible for performing all necessary contract audits for the Department of Defense. DCAA also provides accounting and financial advisory services regarding contracts and subcontracts.

https://doncmra.nmci.navy.mil/ http://www/ecmra.mil

1.8 Department Head. The Government official responsible for managing the operation of a distinct organizational division, office, or unit. The Department Head is subordinate to the Commanding Officer of the local activity.

1.9 Local Activity. The Military Treatment Facility (MTF), research activity, or other organization that falls under the cognizance of BUMED.

1.10 Military Treatment Facility (MTF). A Department of Defense (DoD) hospital or medical or health center where services may be required to be performed under this contract. The abbreviation, “MTF” includes all Branch Medical or Health Clinics, Medical Administrative Units, Branch Medical or Health Annexes and other subordinate clinical activities.

1.11 Naval Medical Logistics Command (NMLC). The Department

of the Navy command responsible for providing contract support for

BUMED.

1.12 Research Activity. N/A

1.13 Technical Assistant (TA). Reserved

2. Responsibilities.

2.1 The Contracting Officer, Acquisition Management Directorate (Code 05), Naval Medical

Logistics Command shall:

2.1.1 Perform all required pre-award actions including providing information or answering questions that arise during the solicitation period and as a result of Freedom of Information Act (FOIA) inquiries.

2.1.2 Review the Contract Administration Plan (CAP).

2.1.3 Verify that the individual(s) nominated to act as COR and/or ACOR have had the required training and the necessary experience. If the Contracting Officer determines that a nominee does not meet experience and training requirements, the Contracting Officer shall request that the local activity nominate another individual.

2.1.4 Review the CAP prior to incorporation into the solicitation. This review shall ensure that all contract administration functions are assigned, suit the specific circumstances of the contract and give due consideration to the type of contract, the place of performance, period of performance, and inspection and acceptance criteria stated in the solicitation/contract.

2.1.5 Include the COR duties contained in this Master CAP in the resultant solicitation/contract.

Additional duties shall be separately delineated within the contract, as appropriate.

2.1.6 Designate the paying office in the contract.

2.1.7 Appoint the COR and ACOR. COR and ACOR appointments shall be completed through the DoD Procurement Integrated Enterprise Environment (PIEE) Tool at:

https://wawf.eb.mil.

2.1.8 Perform all contract administration duties of a Contracting Officer. Regular meetings between the Contracting Officer, the COR or the local activity Commanding Officer (or representative) will be held to discuss the status of and the performance under individual contracts. The format and frequency of these meetings will depend upon the size and complexity of the contract.

NOTE: All parties are specifically reminded that only the Contracting Officer has the authority to modify the terms of the contract. Therefore, in no event will any understanding, agreement, modification, change order, or other matter deviating from the terms of the contract between the Contractor and any other person be effective or binding on the Government. When/if, in the opinion of the Contractor, any direction affecting the terms of the contract has been given by the COR or any other person, the Contractor shall promptly notify the Contracting Officer.

2.1.9 Evaluate reports of Contractor non-compliance and take appropriate action within 30 days of receipt. Copies of any correspondence regarding the results of such analyses shall be provided to the local activity and the COR simultaneously with the action taken.

2.1.10 Arrange the post-award conference, if required. Invite necessary attendees. Ensure that the requirements of the contract and the COR’s duties are thoroughly discussed and understood. Ensure that all personnel involved understand current DoD Standards of Conduct policies.

2.1.11 Oversee the performance of CORs under the contract. Prompt action shall be taken when

COR (or alternate) is not performing properly.

2.1.12 Maintain the official contract file including modifications (and all back-up documentation).

2.1.13 Maintain the accuracy of this Master CAP throughout the life of the contract.

2.1.14 Maintain a list of all CORs under their authority. Periodically review the files and performance of these CORs in accordance with NAVSUPINST 4205.3 (series) and local policies.

2.1.15 Review the existing annual Contractor performance report prior to negotiating (if applicable) any task orders under the contract, extending the contract, or exercising any options under the contract.

2.2. The Commanding Officer of the Local Activity (or designated representative) shall:

2.2.1 Establish policy guidance for the performance of services.

2.2.2 Provide overall direction for services at the activity.

2.2.3 Budget and provide funding for the contract.

2.2.4 Nominate (to the Contracting Officer) an individual to be appointed as COR (by name, title, organizational code and telephone number). This individual (augmented by the activity Department Heads) shall also be the contract quality assurance monitor and lead technical advisor to the Contracting Officer and shall be responsible for the technical interface needed during contract performance. An ACOR can be nominated to act in the absence of the COR, when needed, or to provide additional expertise. COR and ACOR nominations shall be made through the Procurement Integrated Enterprise Environment (PIEE)/ Joint Appointments Module (JAM) at: https://wawf.eb.mil/xhtml/unauth/home/login.xhtml. The local activity approval authority for the COR or ACOR nomination may be the nominee’s supervisor.

NOTE: COR duties cannot be delegated. The COR shall be accountable for the actions of ACORs.

NOTE: Nomination of a new COR or ACOR as a result of reassignment, termination of employment, etc., shall be made in accordance with the procedures outlined herein.

2.2.5 Ensure all individuals nominated as COR or ACOR have the necessary qualifications to satisfactorily perform the required duties and hold a position of responsibility commensurate of the contract. All CORs must complete DAU CLC 106. In addition CORs should complete a Naval Supply System Command (NAVSUP) or BUMED approved COR training course (or DAU/DoD equivalents) prior to appointment under contracts.

2.2.6 Support and supervise the COR in the performance of his/her duties. If the Commanding

Officer determines that assigned duties are not being performed in a satisfactory manner, immediate corrective action shall be taken (including the recommendation to replace the COR if required). The Contracting Officer shall be promptly notified of all actions taken. The local activity should consider COR performance in rating all individuals assigned COR functions.

2.2.7 Ensure that appropriate timely action is taken on all contract related correspondence received from either the Contracting Officer or COR. This includes the timely submission (to the

Contracting Officer) of any requests for changes to the contract, deviations or waivers. An Independent Government Cost Estimate of the impact on contract price and the availability of additional funding (if required) must accompany all requests for changes to the contract. The Contractor’s price quote and the rationale for requesting the change shall accompany any changes proposed by the Contractor. The Contractor’s price quote serves as a budgetary estimate of the cost impact. The local activity shall also provide input as to technical acceptability of proposed contract language changes.

2.2.8 The local activity Commanding Officer may appoint a TA to assist the COR in executing routine administration, monitoring and, surveillance duties. The appointment of all TAs must be in writing and must include the TA's responsibilities and limitations. A copy of this appointment letter shall be provided to the Contracting Officer. Before appointment, the local activity shall assure that all TAs have the appropriate training and experience. TAs must complete DAU CLC 106 prior to appointment. A sample TA appointment letter is located on the NAVSUP Contracting Knowledge Site (CKS) at:

https://www.navsup.navy.mil/cks/reference_library/acquisition_reference_library/forms

2.3 The Contracting Officer's Representative (COR) shall:

2.3.1 Notify the Contracting Officer in writing of any organizational or personnel changes affecting the CAP.

2.3.2 Attend both the pre-proposal and post-award conferences, if held.

2.3.3 Upon receipt of the contract from the Contracting Officer, forward copies of documents to staff having administrative responsibilities for the contract.

2.3.4 Attend periodic meetings (as necessary) among the Contracting Officer, local activity and Contractor to discuss the status of and performance under the contract.

2.3.5 Avoid issuing any instructions that would constitute a change to the contract. The COR and

Contractor shall not enter into any understanding, agreement, modification, or change order deviating from the terms of the contract which shall be effective or binding on the Government.

If in the opinion of the Contractor, an effort outside the scope of the contract is requested, the Contractor shall promptly notify the Contracting Officer in writing. The Contractor shall not act unless the Contracting Officer has issued a written change to the contract. The COR will include, on all correspondence to the Contractor, a declination of authority statement as follows:

“I have neither the authority nor the intent to change the terms or conditions of this contract.

This contract can only be changed by a written modification issued by the Contracting Officer. If you believe that I am requesting an effort outside the scope of this contract, promptly notify the Contracting Officer. Additionally, this shall not be construed as an authorization for new work or additional work not already contained in the contract.”

2.3.6 Perform as the technical interface between the Government and the Contractor for this contract.

The COR shall provide technical advice or clarification regarding the performance work statement and terms of the contract; milestones to be met within the general terms of the contract or specific subtasks of the contract. The COR is the point of contact through whom the Contractor can relay technical questions and problems to the Contracting Officer. The Contractor may also contact the Contracting Officer directly.

http://www.navsup.navy.mil/cks/reference_library/acquisition_reference_library/forms

2.3.7 Coordinate/facilitate complete and timely approvals for work at Government facilities between the local activity and the Contractor. The COR shall inspect the qualifications of each contract employee prior to submission to the local activity if required by the contract.

2.3.8 Monitor Contractor performance and progress under the contract. If potentially inefficient or wasteful methods are being used, the COR shall take reasonable and timely action to alert the Contractor and the Contracting Officer. Furthermore, the COR shall promptly advise the Contracting Officer of any observed continuous and/or substantial deficiencies in the Contractor's performance or other noncompliance with the terms and conditions of the contract.

Section C or the Performance Work Statement of the contract includes the Quality Assurance Surveillance Plan to be used by the COR to monitor Contractor performance. Deviation from this surveillance plan is only permitted with the prospective approval of the Contracting Officer.

2.3.9 In accordance with procedures given in this CAP, promptly issue Contract Discrepancy Reports

(CDRs) (Enclosure (1)) to the Contractor to document discrepant performance. The COR shall always obtain the Contractor's response/rebuttal to the CDR, evaluate, with the affected Department Head, the acceptability of the response and promptly forward the CDR, Contractor response/rebuttal, and their recommendation to the Contracting Officer.

2.3.10 The COR shall recognize that CDRs become official records within the contract file and that they have serious implications for overall contract management and relationships. CDRs shall not be the first and only choice for communicating contract issues with the contractor and shall be implemented in accordance with the procedures given below within this CAP.

2.3.11 For serious contract performance deficiencies, or when less formal communications fail to resolve minor performance deficiencies, the COR will issue a CDR to the Contractor.

2.3.12 The COR shall ensure that all inspection data is attached to the CDR. The Contractor cannot be expected to respond to performance deficiencies that are not clearly and specifically identified. A cover memorandum on the CDR should specify that the Contractor has three working days, or other appropriate deadline, to respond in writing to the COR. At the time the CDR is issued to the Contractor, the COR shall provide a copy of the CDR to the Contracting Officer.

2.3.13 Upon return of the CDR package from the Contractor, the COR shall review the

Contractor’s comments and give careful, objective consideration to the facts and mitigating circumstances documented in the response. The COR shall then make a final written determination and recommendation to the Contracting Officer on the acceptability of Contractor performance and note it on the CDR. The COR shall state why the Contractor’s response does or does not have merit. The COR shall prepare the determination, recommendation, and other statements as appropriate along with actions being requested of the Contracting Officer and as much additional documentation as required to support their conclusions and recommendations.

2.3.14 The COR shall provide the above documentation along with actions being requested of the Contracting Officer and as much additional documentation as required to support their conclusions and recommendations to (1) the Contractor, and (2) the Contracting Officer.

2.3.15 The Contracting Officer will review CDRs and will advise the COR of the need for any further documentation.

2.3.16 Monitor and verify that services are provided in accordance with the performance work statement and terms of the contract. Keep accurate records of Contractor performance and compare these records with the Wide Area Work Flow (WAWF) invoice submitted by the Contractor. The COR shall always use this information as a tool when evaluating Contractor invoices. Monthly Progress Reports should be compared with their corresponding contractor invoices to verify consistency between the two. The COR should review the acceptability of invoices by consideration of the following:

(a) Are there any performance issues?

(b) Are costs appropriate considering current progress of work?

(c) Are required reports up to date?

2.3.17 Notify the Contracting Officer of questioned costs or issues. As required, assist the

Contracting Officer in resolving questioned costs or issues with the contractor.

2.3.18 Accept the services as the official Government representative.

2.3.19 Use appropriate methods for contract surveillance.

2.3.20 Understand contract invoicing requirements. The COR shall ensure that all WAWF Invoices are processed in a timely manner so that prompt…