Amendment-12_June_2018.pdf

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 amendment is to revise the compliance language and update the list of required pharmaceuticals. The required response date/time has changed from 12-Aug-2017 02:00 PM to 19-Jun-2018 09:00 AM.

1. CONTRACT ID CODE PAGE OF PAGES

1 15

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

16C. DATE SIGNED

BY

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 N6264517R0075

X 9B. DATED (SEE ITEM 11)

12-Jul-2017

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 X is extended, 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.

U0001

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

6. ISSUED BY

3. EFFECTIVE DATE

12-Jun-2018

CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

N62645 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N6264517R0075

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 12-Aug-2017 02:00 PM to 19-Jun-2018 09:00 AM.

The following have been modified:

STATEMENT OF REQUIREMENTS

GENERAL REQUIREMENTS:

The effort required hereunder shall be performed in accordance with this Statement of Work and in accordance with all other terms and conditions set forth herein. The contractor shall provide all services, materials, and equipment necessary for compounding and deliveries of Inpatient Narcotic and Anesthesia Pharmaceutical items for the Main Pharmacy, Naval Medical Center San Diego, San Diego, CA.

COMPLIANCE WITH APPLICABLE LAWS AND STANDARDS:

Pharmaceutical compounding pharmacy shall comply with all federal, state and local laws, regulations and governmental orders, including applicable State Board of Pharmacy regulations and United States Pharmacopeia (USP 797) Chapter 800 and Good Compounding Practices (USP 1075), in providing items or services pursuant to this Agreement. Compounding pharmaceuticals shall comply with FDA regulations. Compounding pharmacies and outsourcing facilities shall be regulated and inspected by the FDA and registered by the DEA. Pharmacy staff involved in compounding pharmaceuticals shall be overseen by the state boards of pharmacy in which the facility is located.

CONTRACTOR CHECK-IN/CHECK-OUT:

The contractor shall coordinate with the Main Pharmacy and Materiel Management to get access inside Naval Medical Center San Diego Base and the Main Pharmacy.

LABOR:

All compensation for labor is included in the contract price. Parts and materials: All compensation for parts and materials is included in contract price.

PARTS/SUPPLIES QUALITY:

Contractors require and provide at least quarterly, pharmacy and compounding licenses and quality assurance data for 1-3 lots of each medication ordered. NMCSD must have option to inspect on-site annually. Basis of inspection will be the American Society of Health Systems Pharmacist’s Outsourcing Sterile Products Contractor Assessment Tool. In addition contractor must pass inspection by FDA personnel for continued services.

Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, and durability as in quality. Products shall meet American Society for Testing and Materials. ASTM Background Colors for User-applied Syringe Drug Labels for added safety and shall include TALL MAN lettering and expiration date. Continuity of color for all products must be Color coded specific to individual pharmaceuticals, colors may not be duplicated for any drug, and must remain constant. For example, Atropine label is Blue and must always remain blue and Rocuronium label must always be Red and must always remain red with continuity. Syringe cannot be longer than 6”, 5ml syringe to fit the ASYS drawers. Otherwise larger size products must be plungerless, shrink wrapped to prevent cap from leaking and plungers included separate.

NMCSD must have consistent safe service with no open windows that would lead to possible errors and cause fatality. The color specific individual drug colors purpose is to enhance patient safety.

For all CII pharmaceuticals, appropriate paperwork will be FedEx Overnight with vendor Billable Stamp to vendor.

DELIVERIES:

Compounded Pharmaceuticals and delivery services for NMCSD to be provided in compliance with United States Pharmacopeia (USP 797), Chapter 800 and Good Compounding Practices (USP 1075). Local delivery logistics will be negotiated. Compounding vendor must provide FedEx Billable Stamp for 222 to be mailed via FedEx. Once order is received at Compounding Pharmacy, NMCSD requires order to be delivered to NMCSD Pharmacy via FedEx carrier in no more than three (3) business day ground shipping for large volume parenterals. Monday through Friday orders are to be delivered no later than 10:30am Pacific Time. Next day delivery no later than forty-eight hours from date and time order is placed to contractor. Friday orders require to be delivered no later than Wednesday 10:30am pacific time, and NMCSD Pharmacy will not be charged for any shipping charges on any deliveries within the requirement of this contract. Delivery services for NMCSD are to be provided in compliance with United States Pharmacopeia (USP 797), Chapter 800 and Good Compounding Practices (USP 1075).

Shipping shall be FOB Destination to: Naval Medical Center San Diego (NMCSD).

Delivery Address:

NAVAL MEDICAL CENTER SAN DIEGO, PHARMACY DEPARTMENT (Building 1 Floor 1), 34800 BOB

WILSON DRIVE, SAN DIEGO, CA 92134

Required Pharmaceuticals:

Drug List Phenylephrine 100mcg/ml, 0.5mg/5ml fill syringe (Each) Ephedrine Sulfate 5mg/ml, 25mg/5ml fill syringe (Each) Rocuronium Bromide 10mg/ml, 50mg/5ml fill syringe (Each) Succinylcholine Chloride 20mg/ml, 100mg/5ml fill syringe (Each) Atropine Sulfate 0.4mg/ml, 1mg/2.5ml in 3ml syringe (Each) Fentanyl Citrate 2mcg/ml and Bupivacaine 0.125% in Sodium Chloride 0.9% 100ml bag (Each) Hydromorphone 1mg/ml in Sodium Chloride 0.9% 30ml monoject barrel (Each) NO PLUNGER Morphine Sulfate 5mg/ml in Sodium Chloride 0.9% 30ml monoject barrel (Each) NO PLUNGER Vancomycin HCL 1.25gm D5W 250ml bag (Each) Oxytocin 30 units in 0.9% Sodium Chloride Injection USP 500ML Bag (Each) Ropivacaine HCL 0.2% in 0.9% Sodium Chloride 250ml bag Sodium Phosphate 15mMol D5W 250ml bag (Each) Bupivacaine 0.125% in Sodium Chloride 250ml bag (Each) Epinephrine HCL 10mcg/ml, 50mcg/5ml fill syringe (Each) Ketamine 2mg/ml in Sodium Chloride 0.9% 30ml monoject barrel (Each) NO PLUNGER Bupivacaine 1mg/ml in Sodium Chloride 250ml bag (Each) Bupivacaine 1mg/ml in Sodium Chloride 100ml bag (Each)

In addition to the above, the Government intends to incorporate the selected awardee’s entire catalog of available pharmaceuticals into the scope of the contract for sporadic ordering.

INSTRUCTIONS TO OFFERORS

Questions must be addressed to derek.j.bell.civ@mail.mil by email only NLT 9:00am ET, 19 June 2018. No phone calls will be accepted.

Technical Quote The technical proposal shall clearly indicate, with sufficient details, the vendor’s capability to meet ALL of the requirements of the solicitation. This may include the submission of brochures, publications, a narrative explaining how the vendor will meet the requirements, or any other means which will clearly demonstrate the ability to meet each requirement in the statement or work. Information not included in the quote will not be considered. Links to mailto:derek.j.bell.civ@mail.mil webpages will not be checked and must be printed out and included in the quote.

Past Performance The vendor may provide recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information) for up to three (3) data points within the last three (3) years. Past performance older than three (3) years will be considered not recent. The data shall include, but is not limited to: Organization/Location, POC/Number and email, Contract Reference Number, Contract Date, Total Contract Value and a description of the requirement. The Government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above.

Price Offerors shall use the attached “Pricing Spreadsheet” to submit their price for the required pharmaceuticals. In addition, vendors shall submit their price list for all available pharmaceuticals.

Adequate competition is anticipated for this acquisition. The government anticipates award of a Firm Fixed Price (FFP), Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Offerors shall submit firm-fixed pricing for all above requirements.

Proposal Submission All proposals submitted in response to this solicitation will be submitted electronically via the AMRDEC SAFE website. No paper copies or electronic copies submitted outside of the SAFE website (i.e., emailed directly to the NMLC email inbox) will be accepted.

The AMRDEC SAFE application is used to send large files to individuals which would normally be too large to send via email. There are no user accounts for SAFE - authentication is handled via email and Civilian Access Card (CAC).

The application is available for use by offerors.

The AMRDEC SAFE application can be accessed via https://safe.amrdec.army.mil/safe. Offerors shall proceed as “Non- CAC Users” under all circumstances. After selecting the “Non- CAC Users” option above, the page will be redirected to the package upload form. Fill in all the required input fields (field names are in italics):

Personal Information Your Name - Your name, Your Company Name.

• Your Email address - Your email address.

• Confirm Your Email Address - Re-enter your email address.

File Information

• Description of File(s) - Enter a description for the package;

• File(s) - Click the "Browse" button to select your file(s). You may add up to 25 files per package, so long as the total file size does not exceed 2GB. The total file size is the combined file size of all submitted files.

Deletion Date

• Leave this date at the default setting of two weeks (14 days) from the submission date.

Recipient Information

• Manually Enter Email Address: Input nmlc-research@med.navy.mil and hit the add button. (To remove a recipient, highlight their name and click the "Remove" button.)

Email Settings https://safe.amrdec.army.mil/SAFE/Welcome.aspx mailto:nmlc-research@med.navy.mil

• Check all four of the boxes:

- Encrypt email message when possible.

- Notify me when file(s) downloads are STARTED.

- Notify me when file(s) downloads are COMPLETED.

- Require CAC for Pick-up (all recipients will need to log in with a CAC to download file(s).

• To the right of “Email Settings” is a nondescript box with two options (None or FOUO). Select the

FOUO option and select “sensitive” from the dropdown menu below.

Review all fields for accuracy and hit the ‘submit” button. Clicking the "Submit" button will upload the files and submit the package. Guest users will need to check their email to verify their email address before the recipients will be notified. After the package has been uploaded, the Government will receive a link to the package download page as well as a password. These passwords are unique for each recipient (not the package), and will be disabled once SAFE detects that the user successfully downloaded each file within the package.

Once the offeror has submitted their proposal, they shall send a confirmation to derek.j.bell.civ@mail.mil and provide their company name and contact information as well stating that they have submitted a complete quote to SAFE in response to solicitation N0025917R0075. Submission of proposals is a onetime affair (unless in unusual circumstances multiple SAFE submissions are required because an offeror exceeded the 25 file limit per SAFE submission.). Additional documents will not be accepted after receipt of the confirmation email confirms successful submission of the proposal.

Administrative Information The point of contact for administrative concerns for this order at NMLC, 693 Neiman Street, Fort Detrick, MD 21702 is Derek Bell, 301-619-3020, derek.j.bell.civ@mail.mil.

The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and notwithstanding provisions contained elsewhere in this contract, the said authority remains solely with the Contracting Officer. In the event the Contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without the authority to do so and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

Contracting Officer’s Representative (COR): To be determined at time of award.

Designation of Ordering Activities The following requiring activity is hereby named to Place delivery orders.

NMLC

693 Neiman Street Frederick, MD 21702

Content of Delivery Orders Delivery orders shall contain the following "minimum" information:

• Date of order.

• Contract number and order number.

• Item number and description, quantity, and unit price.

• Delivery date and place of delivery.

• Accounting and appropriation data.

• Payment office address.

• Invoicing instructions.

Ordering The Contracting Officer will order services, equipment and/or supplies against the contract through issuance of Delivery Orders via a DD Form 1155 or SF 1449 signed by the Contracting Officer. Delivery Orders will be executed in writing by the Contracting Officer and transmitted either via facsimile, or electronically via e-mail.

Communications

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

Other Administrative Instructions

• Offerors must be registered in the SAM database to be considered for award. Registration is free and can be completed on-line at http://www.sam.gov; provide DUNS number; Cage Code and TIN.

• The offeror must also include your company’s completed Offer Representations and Certifications (see

FAR 52.212-3).

• Offers shall include their subcontracting plan with their quote. This requirement does not apply to small businesses.

BASIS OF AWARD

This requirement will be evaluated as a Lowest Price Technically Acceptable (LPTA) requirement. The Government intends to evaluate offers and award a contract without discussions. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to make no award of a contract as a result of this combined synopsis/solicitation.

Technical Factors

The government will evaluate each offer to determine the ability to meet the requirements of the solicitation as described in the statement of requirements. This will be rated as acceptable or unacceptable.

Past Performance Factor

The vendor’s past performance will be evaluated for compliance to contract requirements and timeliness. It will be rated as acceptable, unacceptable or unknown.

Price

Proposed prices will be evaluated for reasonableness and completeness.

Evaluation of completeness will include the following: a price for all required pharmaceuticals has been provided for the required four (4) year ordering period, a total price has been submitted, the required provisions, DFARS 252.209-7993 and FAR 52.212-3, ALT I have been completed. Only pricing for the pharmaceuticals listed in the table above will be used for evaluation of price. However, pricing for the entire price list shall be included with the quote. Vendors shall use the attached “Pricing Sheet” to submit their price component.

http://www.sam.gov/

The offeror’s initial proposal shall contain the offeror’s best terms from a price and technical standpoint. The Government intends to evaluate offers and award a contract without discussions, but reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to make no award as a result of this solicitation.

CONTRACTOR MANPOWER REPORTING (NMCARS 08-14)

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the [NAMED COMPONENT] 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 Government 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 October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://doncmra.nmci.navy.mil.

CONTRACTOR SUPPORT NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT

CLOSEOUT FUNCTIONS:

Naval Medical Logistics Command 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 submission of a proposal in response to this solicitation, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

CONTRACT ADMINISTRATION PLAN (CAP)

In order to expedite the administration of this contract, the following delineation of duties is provided. The names, addresses and phone numbers for these offices or individuals are included elsewhere in the contract award document.

The office or individual designated as having responsibility should be contacted for any questions, clarifications, or information regarding the administration function assigned.

1. The Procuring Contract Office (PCO) is responsible for:

a. All pre-award duties such as solicitation, negotiation and award of contracts.

b. Any information or questions during the pre-award stage of the procurement.

c. Freedom of Information inquiries.

d. Changes in contract terms and/or conditions.

e. Post award conference.

2. The Contract Administration Office (CAO) is responsible for matters specified in the FAR 42.302 and DFARS https://doncmra.nmci.navy.mil/ https://doncmra.nmci.navy.mil/

242.302 except those areas otherwise designated as the responsibility of the Contracting Officer's Representative (COR) or someone else herein.

3. The paying office is responsible for making payment of proper invoices after acceptance is documented.

4. The Contracting Officer's Representative (COR) is responsible for interface with the contractor and performance of duties such as those set forth below. It is emphasized that only the PCO/CAO has the authority to modify the terms of the contract. In no event will any understanding, agreement, modification, change order, or other matter deviating from the terms of the basic contract between the contractor and any other person 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 PCO in writing. No action may be taken by the contractor unless the PCO or CAO has issued a contractual change. The COR duties are as follows:

a. Technical Interface

(1) The COR is responsible for all Government technical interface concerning the contractor and furnishing technical instructions to the contractor. These instructions may include: technical advice/recommendations/clarifications of specific details relating to technical aspects of contract requirements; milestones to be met within the general terms of the contract or specific subtasks of the contract; or, any other interface of a technical nature necessary for the contractor to perform the work specified in the contract. The COR is the point of contact through whom the contractor can relay questions and problems of a technical nature to the PCO.

(2) The COR is prohibited from issuing any instruction which would constitute a contractual change. The COR shall not instruct the contractor how to perform. If there is any doubt whether technical instructions contemplated fall within the scope of work, contact the PCO for guidance before transmitting the instructions to the contractor.

b. Contract Surveillance

(1) The COR shall monitor the contractor's performance and progress under the contract. In performing contract surveillance duties, the COR should exercise extreme care to ensure that he/she does not cross the line of personal services. The COR must be able to distinguish between surveillance (which is proper and necessary) and supervision (which is not permitted). Surveillance becomes supervision when the COR goes beyond enforcing the terms of the contract. If the contractor is directed to perform the contract services in a specific manner, the line is being crossed.

In such a situation, the COR's actions would be equivalent to using the contractor's personnel as if they were government employees and would constitute transforming the contract into one for personal services.

(2) The COR shall monitor contractor performance to see that inefficient or wasteful methods are not being used. If such practices are observed, the COR is responsible for taking reasonable and timely action to alert the contractor and the PCO to the situation.

(3) The COR will take timely action to alert the PCO to any potential performance problems. If performance schedule slippage is detected, the COR should determine the factors causing the delay and report them to the PCO, along with the contractor's proposed actions to eliminate or overcome these factors and recover the slippage. Once a recovery plan has been put in place, the COR is responsible for monitoring the recovery and keeping the PCO advised of progress.

(4) If the Contractor Performance Assessment Reporting System (CPARS) is applicable to the contract you are responsible for completing a Contractor Performance Assessment Report (CPAR) in the CPARS Automated Information System (AIS). The initial CPAR, under an eligible contract, must reflect evaluation of at least 180 days of contractor performance. The completed CPAR, including contractor comments if any, (NOTE: contractors are allowed 30 days to input their comments) should be available in the CPARS AIS for reviewing official (PCO) review no later than 270 days after start of contract performance. Subsequent CPARs covering any contract option periods should be ready at 1-year intervals thereafter.

c. Invoice Review and Approval/Inspection and Acceptance

(1) The COR is responsible for quality assurance of services performed and acceptance of the services or deliverables. The COR shall expeditiously review copies of the contractor's invoices or vouchers, certificate of performance and all other supporting documentation to determine the reasonableness of the billing. In making this determination, the COR must take into consideration all documentary information available and any information developed from personal observations.

(2) The COR must indicate either complete or partial concurrence with the contractor's invoice/voucher by executing the applicable certificate of performance furnished by the contractor.

The COR must be cognizant of the invoicing procedures and prompt payment due dates detailed elsewhere in the contract.

(3) The COR will provide the PCO and the CAO with copies of acceptance documents such as

Certificates of Performance.

(4) The COR shall work with the Contractor to obtain and execute a final invoice no more than 60 days after completion of contract performance. The COR shall ensure that the invoice is clearly marked as a “Final Invoice.”

d. Contract Modifications. The COR is responsible for developing the statement of work for change orders or modifications and for preparing an independent government cost estimate of the effort described in the proposed statement of work.

e. Administrative Duties

(1) The COR shall take appropriate action on technical correspondence pertaining to the contract and for maintaining files on each contract. This includes all modifications, government cost estimates, contractor invoices/vouchers, certificates of performance, DD 250 forms and contractor's status reports.

(2) The COR shall maintain files on all correspondence relating to contractor performance, whether satisfactory or unsatisfactory, and on trip reports for all government personnel visiting the contractor's place of business for the purpose of discussing the contract.

(3) The COR must take prompt action to provide the PCO with any contractor or technical code request for change, deviation or waiver, along with any supporting analysis or other required documentation.

f. Government Furnished Property. When government property is to be furnished to the contractor, the COR will take the necessary steps to insure that it is furnished in a timely fashion and in proper condition for use. The COR will maintain adequate records to ensure that property furnished is returned and/or that material has been consumed in the performance of work.

g. Security. The COR is responsible for ensuring that any applicable security requirements are strictly adhered to.

h. Standards of Conduct. The COR is responsible for reading and complying with all applicable agency standards of conduct and conflict of interest instructions.

i. Written Report/Contract Completion Statement.

(1) The COR is responsible for timely preparation and submission to the PCO, of a written, annual evaluation of the contractors performance. The report shall be submitted within 30 days prior to the exercise of any contract option and 60 days after contract completion. The report shall include a written statement that services were received in accordance with the Contract terms and that the contract is now available for close-out. The report shall also include a statement as to the use made of any deliverables furnished by the contractor.

(2) If the Contractor Performance Assessment Reporting System (CPARS) is applicable to the contract the COR is responsible for completing a final Contractor Performance Assessment Report (CPAR) in the CPARS with 30 days of contract completion.

(3) The COR is responsible for providing necessary assistance to the Contracting Officer in performing Contract Close-out in accordance with FAR 4.804, Closeout of Contract Files.

5. The Technical Assistant (TA), if appointed, is responsible for providing routine administration and monitoring assistance to the COR. The TA does not have the authority to provide any technical direction or clarification to the contract. Duties that may be performed by the TA are as follows:

a. Identify contractor deficiencies to the COR.

b. Review contract deliverables, recommend acceptance/rejection, and provide the COR with documentation to support the recommendation.

c. Assist in preparing the final report on contractor performance for the applicable contract in accordance with the format and procedures prescribed by the COR.

d. Identify contract noncompliance with reporting requirements to the COR.

e. Review contractor status and progress reports, identify deficiencies to the COR, and provide the COR with recommendations regarding acceptance, rejection, and/or Government technical clarification requests.

f. Review invoices and provide the COR with recommendations to facilitate COR certification of the invoice.

g. Provide the COR with timely input regarding technical clarifications for the statement of work, possible technical direction to provide the contractor, and recommend corrective actions.

h. Provide detailed written reports of any trip, meeting, or conversation to the COR subsequent to any interface between the TA and contractor.

Health Insurance Portability and Accountability Act (HIPAA)

The contractor shall comply with the HIPAA Act of 1996 (Public Law 104-191) requirements, specifically the administrative simplification provision s of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Business Associate Agreement

In accordance with DoD 6025.18-R “Department of Defense Health Information Privacy Regulation” 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 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 DODI 6025.18-R.

Individual has the same meaning as the term ̀ `individual'' in 45 CFR 164.501 and 164.103 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 164.501, limited to the information created or received by The Contractor from or on behalf of The Government.

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 164.501 and 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,

164.501 and 164.304.

(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 shall 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 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 Contract.

(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 of.

(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 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 or an Individual, and in the time and manner 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 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 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 Privacy Rule, the 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) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(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 Privacy Rule 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.

252.232-7006, WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area Workflow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data

Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

Invoice and Receiving Report COMBO

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

Destination / Destination

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table

Field Name in WAWF Data to be entered in WAWF Pay Official DoDAAC HQ0248 Issue By DoDAAC N62645 Admin DoDAAC N62645 Inspect By DoDAAC N/A Ship To Code N00259 Ship From Code N/A Mark For Code N/A Service Approver (DoDAAC) N/A Service Acceptor (DoDAAC) N/A Accept at Other DoDAAC N/A LPO DoDAAC N00259 DCAA Auditor DoDAAC N/A Other DoDAAC(s) N/A

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g.

timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications'' field of WAWF once a document is submitted in the system.

To be determined at contract award

(Contracting Officer: Insert applicable email addresses or “Not applicable.'')

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

usn.detrick.navmedlogcomftdmd.list.nmlc-wawf@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988. (End of clause)

(End of Summary of Changes)