Amended_PWS_ASC_2016_06_16.doc

PERFORMANCE WORK STATEMENT (PWS)

Ambulatory Surgical Center Quality & Safety Improvement Program

General Information

1. General:

This is a Non-personal services contract to provide memberships, membership support and training. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide memberships, membership support and training as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background:

As a result of the Secretary of Defense mandated 90 day review of access, safety and quality in the Military Health System (MHS), three surgical care focused recommendations were developed. They included:

· MHS governance should task the National Surgical Quality Improvement Program (NSQIP®) working group to assess surgical morbidity shortfalls to the Medical Operations Group for Tri-Service/Defense Health Agency (DHA) engagement, collaborative support, and facility action. (within 90 days)

· DHA Healthcare Operations Directorate should partner with the American College of Surgeons (ACS) NSQIP® staff to improve military treatment facility (MTF) collaboration and the sharing of best practices from the top performing facilities, thereby decreasing overall direct care surgical morbidity and improving clinical outcomes. (within 90 days)

· MHS governance should explore expanding NSQIP® participation to all remaining direct care inpatient facilities performing surgery. In addition, ensure ambulatory surgery platforms all participate in a similar surgical quality improvement program.

A decision paper on ambulatory surgical center MTFs participation in a national surgical quality improvement benchmark program was drafted and approved by MHS senior leadership. The decision was to have all ambulatory surgical center MTFs participate in a consistent database to facilitate internal comparison for successful practice identification and collaborative learning.

1.3 Objectives:

The purpose of the contract is to meet the following objectives as established by the Program Office. The Military Health Systems (MHS) will benefit from participating in an Ambulatory Surgical Center (ASC) Benchmarking Program for many reasons; most importantly the program will contribute to the reduction of surgical morbidity and to enhance clinical quality and safety activities at Department of Defense (DoD) ASCs. An ASC Benchmarking Program enhances the ability of the DoD to validate and/or improve the quality of surgical care provided by participating military treatment facilities while maintain compliance with related DoD quality assurance and patient privacy directives. The Objectives to be met to satisfy the requirements of this program are:

1.3.1. To provide reliable, valid and accessible quality data on ambulatory surgical care to surgical specialists and MHS leadership thus allowing for consistent monitoring of care to validate or improve surgical outcomes.

1.3.2. To provide a model for continuous quality improvement of ambulatory surgical care that leads to decreased variability and increased quality in patient care while reducing costs and increasing value.

1.3.3. To compare aggregate ambulatory surgical data and outcomes of participating DoD Military Treatment Facilities with each other and with comparable patient populations from across the nation through a continually accessible current data source.

1.3.4. To support a DoD system-wide surgical quality improvement program focused on improving processes, structures, and systems to ensure quality surgical care.

1.3.5. To support the DoD MTFs and Program Office in meeting quality assurance directive and patient privacy requirements throughout the implementation of an ASC Benchmarking Program.

1.3.6. Provide on-going training, education, and support to Clinical Data Abstractors (CDAs).

1.4 Scope: This contract provides for memberships to participate in an ambulatory surgical center benchmarking program and program support for designated MTFs with non-hospital ambulatory surgery centers. The designated program will provide for both quality and safety data collection and reporting. MTFs supported by this effort will have the ability to compare their results to national benchmark standards and between participating tri-service MTFs. The Service Headquarters and the Defense Health Agency (DHA) will also have access to this data. The memberships provide for the following key services:

1. Training of clinical data abstractors (CDA) on variables for preoperative risk factors, intraoperative events, and 48-hour post-operative mortality and morbidity for patients who undergo ambulatory surgical procedures in the outpatient setting.

2. Dashboards that allow for continual viewing of quality and safety data allowing MTFs to rapidly implement process improvement initiatives for identified quality and safety outliers.

3. Dashboards that allow for continual viewing of aggregated MTF data allowing for comparison between participating DoD MTFs. The Service Headquarters and DHA would also have access to this data.

4. Quarterly reports that provide MTFs with quality and safety data that allow for MTF and enterprise level oversight of quality and safety measures and initiatives. (membership)

5. Provide data in facilitating accreditation by The Joint Commission. (membership)

6. Provide data to maintain alignment with nationally recognized ambulatory surgery centers such as rs for Medicare & Medicaid Services (CMS). (membership)

7. Membership support services and database availability.

8. 9 Sites include:

Ambulatory Surgical Center, Naval Medical Center, Portsmouth, VA

Wilford Hall Ambulatory Surgical Center, San Antonio, TX

McDonald Army Health Center Fort Eustis, VA

Kimbrough Ambulatory Care Center, Fort Meade, MD

10th Medical Group, Ambulatory Surgery Center, U.S. Air Force Academy, CO 79th Medical Wing, Malcolm Grow Ambulatory Surgical Center, Joint Base Andrews, MD

Munson Army Ambulatory Surgical Center, Ft. Leavenworth, KS

Ambulatory Surgery Center, Naval Health Clinic, Cherry Point, SC

Ambulatory Surgery Center, Naval Hospital, Lemoore, CA

8.5 Period of Performance: The period of performance shall be for one (1) Base Year of 6 months and four (4) 12-month option years.

8.6 The base period of performance will cover the six non-US Air Force ASCs. The option periods will cover all nine of the above facilities.

8.7 The Period of Performance reads as follows:

Base Period

Date of award of contract 2016 – December 31, 2016

Option Period 1

12 month period of performance January 1, 2017 – December 31, 2017

Option Period 2

12 month period of performance January 1, 2018 – December 31, 2018

Option Period 3

12 month period of performance January 1, 2019 – December 31, 2019

Option Period 4

12 month period of performance January 1, 2010 – December 31, 2020

1.6 General Information

1.6.1 Quality Control Plan: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which he assures himself that his work complies with the requirement of the contract. The Quality Control Plan (QCP) (Deliverable 1) shall be included in the offeror’s technical proposal submitted for this requirement. After award, the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to their QC system.

The Contractor shall prepare and adhere to a Quality Control Plan (QCP). The final QCP shall be submitted within five (5) workdays after notification by the Contracting Officer if revisions are required. The QCP shall document how the Contractor will meet and comply with the quality standards established in this statement of work.

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP) (provided in Technical Exhibit 1). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. The PWS defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.2.1 Acceptance Criteria: Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Requirements Summary (PRS) (provided in Technical Exhibit 2) Matrix and all terms and conditions of this order, including all modifications.

1.6.3 Recognized Holidays: During the following holidays, Government facilities will be closed. The contractor is required to conduct work efforts for this PWS whenever Government facilities are open. There will be no payments for Holiday services unless as stated in the PWS or as directed by the COR.

New Year’s Day

Labor Day

Martin Luther King Jr.’s Birthday

Columbus Day

President’s Day

Veteran’s Day

Memorial Day

Thanksgiving Day

Independence Day

Christmas Day

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 8am – 4:30 pm, Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the contractors offices in support of the designated DoD ACS.

1.6.6 Type of Contract: The government will award a firm fixed price Contract.

1.6.7 Security Requirements: Not Applicable

1.6.7.1 Physical Security: Not Applicable

1.6.7.2 Key Control: Not Applicable

1.6.7.3 Lock Combinations: Not Applicable

1.6.8 Special Qualifications: Not Applicable

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to participate in any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: Not Applicable

1.6.12 Identification of Contractor Employees: All contract personnel attending meetings or working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

1.6.13 Contractor Travel: Not Applicable

1.6.14 Other Direct Costs: Not Applicable

1.6.15 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced for the Government under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.16 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

Refer to Technical Exhibit 5 for OCI language. The contractor shall complete the OCI Certification (Deliverable 2) provided in Technical Exhibit 5 and submit to the Contracting Officer with their proposal. If a perceived OCI issue occurs at any time during performance of this contract, the Contractor shall notify the CO and COR and complete a new OCI form and OCI mitigation plan as appropriate.

1.6.17 Phase In/Phase Out Period: Not Applicable

PART 2

DEFINITIONS & ACRONYMS

2.0 Definitions and Acronyms:

2.1. Definitions:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. Acronyms:

ACOR

Alternate Contracting Officer's Representative

ASC

Ambulatory Surgical Center

CDA

Clinical Data Abstractor

CFR

Code of Federal Regulations

CONUS

Continental United States (excludes Alaska and Hawaii)

CO

Contracting Officer

COR

Contracting Officer Representative

COTR

Contracting Officer's Technical Representative

COTS

Commercial-Off-the-Shelf

DACA

Days After Contract Award

DD254

Department of Defense Contract Security Requirement List

DFARS

Defense Federal Acquisition Regulation Supplement

DHA

Defense Health Agency

DMDC

Defense Manpower Data Center

DOD

Department of Defense

FAR

Federal Acquisition Regulation

HIPAA

Health Insurance Portability and Accountability Act of 1996

MHS

Military Health System

MTF

Military Treatment Facility

OCI

Organizational Conflict of Interest

OCONUS

Outside Continental United States (includes Alaska and Hawaii)

ODC

Other Direct Costs

PIPO

Phase In/Phase Out

POC

Point of Contact

PRS

Performance Requirements Summary

PWS

Performance Work Statement

QA

Quality Assurance

QAP

Quality Assurance Program

QASP

Quality Assurance Surveillance Plan

QC

Quality Control

QCP

Quality Control Program

TE

Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.0 Government Furnished Items and Services:

3.1. Services: Not Applicable

3.2 Facilities: Not Applicable

3.3 Utilities: Not Applicable

3.4 Equipment: Not Applicable

3.5 Materials: Not Applicable

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.0 Contractor Furnished Items and Responsibilities:

4.1 General: Not Applicable

4.2 Secret Facility Clearance: Not Applicable

4.3. Materials: Not Applicable

4.4. Equipment: Not Applicable

PART 5

SPECIFIC TASKS

5.0 Specific Tasks:

5.1. Basic Services: The contractor shall provide membership to benchmarking program for clinical process and outcomes measures for DoD ASCs participation in order to assess the quality of ambulatory surgical services.

5.2. Training of Clinical Data Abstractors (CDAs) on variables for intraoperative events, and 48 hour postoperative mortality and morbidity outcomes for patients undergoing ambulatory surgical procedures in the outpatient setting. Electronic web-based will be provided by the contractor.

5.3. Data quality assurance, comparative analysis, and reporting of observed surgical process and outcomes based on a nationally recognized ASC measures. This includes:

1. Ensure hospital reports are available to access readily in the contractor database which provides for continual viewing of aggregated facility data for comparison with other participating sites as well as DoD system aggregated data through established and ad hoc reporting capabilities.

2. Data quality audits shall be conducted to enhance reliability and validity ASC data.

5.4. Quarterly reports shall be provided every three (3) months to the COR, the ASCs, the Service Headquarters and the DHA to include a data analysis of morbidity and mortality (Deliverable 3). The contractor shall provide an Excel spreadsheet of the data in the report to support DoD with data display and reporting options.

5.5. Availability of Contractor Database for data entry by the CDAs. The contractor database is to be available 95% of the time excluding planned maintenance. The contractor shall acknowledge receipt of any technical support issue within eight (8) business hours and provide resolution within 48 hours of receipt. The correction of any deficiencies shall be at no cost to the Government.

5.6. Support Services for participation in benchmarking program membership shall be available to support staff and address questions and issues related to the participation and use of the products/database. Questions and support requests will be responded to or resolved within three business days.

OTHER TERMS, CONDITIONS, AND PROVISIONS

6.0 Other Terms, Conditions, and Provisions 6.1 Non-Disclosure /Non-Use Agreement The Contractor shall ensure that the Non-Disclosure/Non-Use Agreement (provided in Technical Exhibit 6) is signed by all staff assigned to or performing on this Task order before performing any work, including all subcontractors and consultants. The Non-Disclosure/Non-Use Agreement shall be cosigned by a corporate official (Contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of staff who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. Assignment of staff who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor.

6.2 Information Assurance/General Security Requirements The contractor shall comply with DoD Directive 8500.1, "Information Assurance (IA)," DoD Instruction 8500.2, "Information Assurance (IA) Implementation," DoD Directive 5400.11, "DoD Privacy Program," DoD 6025.18-R, "DoD Health Information Privacy Regulation," and DoD 5200.2-R, "Personnel Security Program Requirements." Follow the Defense Health Agency (DHA) Privacy Office guidelines for submittal of Automated Data Processor/Information Technology (ADP/IT) security clearances and ensure all contractor personnel are designated as ADP/IT-I, ADP/IT-II, or ADP/IT-III where their duties meet the criteria of the position sensitivity designations. Contact the DHA Privacy Office for guidance on the appropriate ADP/IT levels for personnel on the contract. The DHA Privacy Office procedures for personnel security are listed on the following website: www.tricare.mil/tma/privacy. (Technical Exhibit 3) 6.4.1 Dissemination of Information/Publishing There shall be no dissemination or publication, except within and between the Contractor and any subcontractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the DHA Program Manager (PM) or the Contracting Officer. DHA approval for publication will require provisions which protect the intellectual property and patent rights of both DHA and the Contractor.

6.5 Contractor Employees

6.5.1 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

6.5.2 Attendance at Meetings: Contractor personnel may be required to participate in meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel make their Contractor status known during introductions.

6.5.3 Use of Military Rank by Contractor Personnel: Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract under which they provide services.

6.6 Enterprise-wide Contractor Manpower Reporting Application (eCMRA) N/A CONTRACTOR MANPOWER REPORTING FOR CONTRACT 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 Defense Health Agency Healthcare Operations Directorate, Clinical Support Division via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.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 at help desk at: http://www.ecmra.mil

PART 7

APPLICABLE PUBLICATIONS

7.0 Applicable Publications (Current Editions)

7.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

PART 8

TECHNICAL EXHIBIT LISTING

8. Technical Exhibit List:

Technical Exhibit 1 – Quality Assurance Surveillance Plan (QASP)

Technical Exhibit 2 – Performance Requirements Summary

Technical Exhibit 3 – Standard HIPAA Language

Technical Exhibit 4 – Deliverables Schedule Technical Exhibit 5 – Organizational Conflict of Interest (OCI)

Technical Exhibit 6 – DHA Contractor Non-Disclosure Agreement (NDA)

TECHNICAL EXHIBIT 1

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Ambulatory Surgical Center Quality & Safety Improvement Program

1. Purpose

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored.

· How monitoring will take place.

· Who will conduct the monitoring.

· How monitoring efforts and results will be documented.

2. Background

This QASP is a Government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the objectives included in the Performance Work Statement (PWS) for the Ambulatory Surgical Center Quality & Safety Improvement Program. The intent is to ensure that the contractor performs in accordance with the performance metrics and the Government receives the quality of services called for in the contract.

3. Objectives

This contract requirement is to provide memberships to an ambulatory surgical center (ASC) benchmarking program and program support for designated ASC Military Treatment Facilities (MTF). The contractor provides training for clinical data abstractors (CDA) and data collection tools. The contractor will provide data analysis with national comparative data and real time data for individual facilities, Services (Air Force, Army and Navy), and the Military Health System level aggregate data. The resulting vehicle will be a Firm Fixed Price (FFP) Contract. This contract is for a base year of 12 months, with four option periods of 12 months each. A properly executed QASP will assist the Government in achieving the objectives of this procurement.

This QASP does not detail how the Contractor accomplishes the work. Rather, the QASP is created with the premise that the Contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis to ensure that the QASP remains a valid, useful, and enforceable document. However, the Government will coordinate changes with the Contractor. Copies of the original QASP and revisions will be provided to the Contractor and Government officials implementing surveillance activities.

4. Government Roles and Responsibilities

The following Government personnel are responsible for overseeing and coordinating surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall ensure that the Contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

Assigned CO: Krishana M. Wright Organization or Agency: Defense Health Agency, Contract Operations Division (DHA-COD)

Telephone: 703-681-6786 Email: krishana.m.wright.civ@mail.mil

b. Contracting Officer’s Representative (COR) - The COR shall be responsible for technical administration of the contract and shall ensure proper Government surveillance of the Contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the CO, the COR shall provide corresponding documentation to the CO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The Contractor shall refer any changes they deem may affect contract price, terms, or conditions to the CO for action.

Assigned COR: Maria Feaster Telephone: 703-681-0081

Email: maria.e.feaster.civ@mail.mil

5. Contractor Representatives

The following employees of the Contractor serve as the Contractor’s Program Manager and Task Manager for this contract.

a. Program Manager

Telephone:

Email:

b. Task Manager

Telephone:

Email:

6. Methods of QA Surveillance

Various methods exist to monitor performance. The COR will use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the Contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR will be responsible for monitoring the Contractor’s performance in meeting a specific performance standard/AQL.

a. DIRECT OBSERVATION. Performed periodically or through 100% surveillance as needed.

b. PERIODIC INSPECTION. Done as required.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Based on complaints from leadership, division directors, Services and MTF representatives.

d. 100% INSPECTION.

Surveillance results may be used as the basis for actions (to include payment deductions) against the Contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the CO’s actions.

7. Ratings Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

8. Documenting Performance

a. ACCEPTABLE Performance.

The Government will document positive performance. A report template is attached. Any report may become a part of the supporting documentation history.

b. UNACCEPTABLE performance.

When unacceptable performance occurs, the COR shall inform the Contractor. This notification will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the Contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government will review the Contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions or other actions deemed necessary by the CO.

9. Frequency of Measurement

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR will meet with the Contractor to assess performance at a minimum of yearly to assess performance and provide a written assessment.

Performance Report

< This template will be used to formally document surveillance. >

1. CONTRACT NUMBER:

2. Prepared by:

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by:

Signature – Task Order Contracting Officer’s Representative

Date

Contract Discrepancy Report (CDR)

< This template will be used to formally document discrepancies. >

1. Contract Number:

2. TO: (Contractor Task Manager or on-site representative)

3. FROM:

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

5. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this CDR. >

Prepared by:

Signature – Task Order Contracting Officer’s Representative

Date

Received by:

Signature - Contractor Task Manager or on-site representative

TECHNICAL EXHIBIT 2

PERFORMANCE REQUIREMENTS SUMMARY

Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix below includes performance standards. The Government will use these standards to determine Contractor performance and will compare Contractor performance to the Acceptable Quality Level (AQL).

1. ASC Membership Participation Agreements annual renewal

TECHNICAL EXHIBIT 3

STANDARD HIPAA LANGUAGE

Personally Identifiable Information(PII), Protected Health Information (PHI),and Federal Information Requirements (Revised April 2, 2014)

1. General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Privacy and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and DoD issuances. In general, the Contractor shall comply with the specific requirements set forth in this section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein.

This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

For purposes of this Section, the following definitions apply.

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (May 8, 2007 thru Change 1 September 1, 2011) and DoD 5400.11-R (May 14, 2007).

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, 78 FR 5566-5702 (January, 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD 6025.18-R (January 24, 2003), DoDI 6025.18 (December 2, 2009), and DoD 8580.02-R (July 12, 2007).

DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate (NCRMD).

Service-Level Privacy Office means a privacy office of one of the military Services (Army, Navy, or Air Force). The Service-Level Privacy Offices have authority over Privacy Act and HIPAA compliance by the military Services. [This definition is applicable to this Contract if the Government party to this Contract is one of the Services or a Service component. In that case, this Section may need Service-specific provisions in addition to this definition.] Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of a breach in 45 CFR 164.402.

2. Records Management When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 U.S.C. Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B – Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI-15), “OSD Records and Information Management Program” (May 3, 2013).

3. Freedom of Information Act (FOIA) The Contractor shall comply with the following procedures if it receives a FOIA request and immediately contact the DHA FOIA Officer for evaluation/action:

The Contractor shall inform beneficiaries that DHA FOIA procedures require a written request addressed to the DHA Freedom of Information Service Center, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042-5101 (or email requests addressed to FOIARequests@tma.osd.mil), and that the request shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. Although the administrative time limit to grant or deny a request (ten working days after receipt) does not begin until the request is received by DHA, the Contractor shall act as quickly as possible.

In response to requests received by the Contractor for the release of information, unclassified information, documents and forms which were previously provided to the public as part of routine services shall continue to be made available in accordance with previously established criteria. All other requests from the public for release of DHA records and, specifically, all requests that reference the Freedom of Information Act shall be immediately forwarded to DHA, ATTENTION: Freedom of Information Officer, for appropriate action. Direct contact, including interim replies, between TRICARE contractors and such requestors is not authorized. The Contractor shall process requests by individuals for access to records about themselves in accordance with directions from the DHA Freedom of Information Service Center. If such a requestor specifically makes the request under the Privacy Act or does not make clear whether the request is made under FOIA or the Privacy Act, the Contractor shall process the request in accordance with directions from the DHA Privacy Office. If requestor specifically seeks PHI under HIPAA, the Contractor shall follow paragraph 8.1.6, relating to individual rights of access to PHI.

4. Systems of Records In order to meet the requirements of the Privacy Act and the DoD Privacy Act Issuances, the Contractor shall identify to the DHA Contracting Officer (CO) systems of records that are or will be maintained or operated for DHA where records of PII collected from individuals are maintained and specifically retrieved using a personal identifier. Upon identification of such systems to the CO, and prior to the lawful operation of such systems, the Contractor shall coordinate with the DHA Privacy Office to complete systems of records notices (SORNs) for submission and publication in the Federal Register as coordinated by the Defense Privacy and Civil Liberties Office, and as required by the DoD Privacy Act Issuances.

Following proper SORN publication and Government confirmation of Contractor authority to operate the applicable system(s), the Contractor shall also comply with the additional systems of records and SORN guidance, in coordination with the DHA Privacy Office, regarding periodic system review, amendments, alterations, or deletions set forth by the DoD Privacy Act Issuances, Office of Management and Budget (OMB) Memorandum 99-05, Attachment B, and OMB Circular A-130. The Contractor shall promptly advise the DHA Privacy Office of changes in systems of records or their use that may require a change in the SORN.

5. Privacy Impact Assessment (PIA) The Contractor shall provide for the completion of a PIA for any applicable systems that collect, maintain, use or disseminate PII or PHI about members of the public, federal personnel, contractors, or in some cases foreign nationals. The Contractor shall establish practices that satisfy the requirements of DoDI 5400.16, “DoD Privacy Impact Assessment (PIA) Guidance.” (February 12, 2009).

To begin the PIA process, the Contractor shall use the DoD-approved PIA Template, DD Form 2930. The Contractor shall use the DHA PIA Guide to complete the DD Form 2930. The Contractor should send completed DD Form 2930s to the DHA Privacy Office for review and approval, with a copy to the CO.

6. Data Sharing Agreement (DSA) (Applies if contract requirements involve PII/PHI or de-identified data that would be PII/PHI) The Contractor shall consult with the DHA Privacy Office to determine if the Contractor must obtain a Data Sharing Agreement (DSA) or Data Use Agreement (DUA), when MHS data that is managed by DHA will be accessed, used, disclosed or stored, to perform the requirements of this Contract. The Contractor shall comply with requests for additional documentation by the DHA Privacy Board when requesting PHI for research.

In addition, the Contractor shall submit any research requests for MHS data that include PHI to the DHA Privacy Board in order to be reviewed for HIPAA compliance.

The Contractor shall comply with the permitted uses established in a DSA/DUA to prevent the unauthorized use and/or disclosure of any PII/PHI, in accordance with the HIPAA Rules and the DoD HIPAA Issuances. Likewise, the Contractor shall comply with the DoD Privacy Act Issuances.

To begin the data sharing request process, the Contractor shall submit a Data Sharing Agreement Application (DSAA) to the DHA Privacy Office. If the application is approved, the requestor shall enter into one of the following agreements, depending on the data involved:

DSA for De-Identified Data

DSA for PHI

DSA for PII Without PHI

Data Use Agreement for Limited Data Set.

DSAs are active for one year, or until the end of the current option year, whichever comes first. If the DSA will not be renewed, the Contractor shall provide a Certificate of Data Disposition (CDD) to the DHA Privacy Office.

7. Privacy Act and HIPAA Training The Contractor shall ensure that its entire staff, including subcontractors and consultants that perform work on this Contract receive training on the Privacy Act, HIPAA, the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) Reorganization Act, 42 U.S.C. 290dd-2, and the ADAMHA implementing regulations, 42 CFR Part 2.

The Contractor shall ensure all employees and subcontractors supply a certificate of all training completion to the Contracting Officer’s Representative (COR) within 30 days of being assigned and on an annual basis based on the trainee’s birth month thereafter (Deliverable 4).

8. HIPAA Business Associate Provisions

8.1 Business Associate – General Provisions

The Contractor meets the definition of Business Associate, and DHA meets the definition of a covered entity under the HIPAA Rules and the DoD HIPAA Issuances. Therefore, a Business Associate Agreement (BAA) between the Contractor and DHA is required to comply with the HIPAA Rules and the DoD HIPAA Issuances. This paragraph 8 serves as the required BAA. As a Business Associate, the Contractor shall comply with the HIPAA Rules and the DoD HIPAA Issuances applicable to a business associate performing under this Contract.

8.1.1 Catch-All Definition: The following terms used, but not otherwise defined in paragraph 8.1, shall have the same meaning as those terms have in the DoD HIPAA Issuances: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information (Unsecured PHI), and Use.

8.1.2 The Contractor shall not use or further disclose PHI other than as permitted or required by the Contract or as Required by Law.

8.1.3 The Contractor shall use appropriate safeguards, and comply with the HIPAA Security Rule with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Contract.

8.1.4 The Contractor shall report to DHA any breach of which it becomes aware, and shall proceed with breach response steps as required by Paragraph 9.