MFT_PWS_Antomic_Pathology_Services.doc

PERFORMANCE WORK STATEMENT

ANATOMIC PATHOLOGY SERVICES

Medical Treatment Facility, David Grant Medical Center

Travis AFB, California

5 Oct 2016 Table of Contents

Section

Title

Description of Services

Contractor Responsibilities

Services Summary

General Information

Appendix A

Applicable Publications Appendix B

Standard Abbreviations and Terms

PERFORMANCE WORK STATEMENT

ANATOMIC PATHOLOGY SERVICES

Medical Treatment Facility, David Grant Medical Center

Travis AFB, California

1. DESCRIPTION OF SERVICES

1.1. The contractor shall provide all management, labor, tools, equipment, transportation, and materials necessary to provide comprehensive tests. Tests will be used in diagnosing and providing prognostic and therapeutic information for pathologic neoplasms. The services required include immunohistochemistry, flow cytometry, Fluorescence In Situ Hybridization (FISH), molecular markers, cytogenetics, next genetic sequencing as well as consultative services. Contractor shall provide transportation of specimens and materials, and all other services identified necessary to perform the testing listed in this Performance-based Work Statement (PWS) for the 60th Medical Group, David Grant Medical Center (DGMC), Department of Pathology, Laboratory and Pathology Flight, Travis Air Force Base. The contractor shall comply with the Joint Commission Organization (JC), all Federal, State, and local laws applicable to the performance of work including the Food and Drug Administration (FDA), and shall provide up to date CAP and CLIA licensure. The terms “must,” “shall” and “will” denote mandatory actions in this PWS. This includes all direct and indirect resources.

2. CONTRACTOR RESPONSIBILITIES

2.1. Specimen testing services required for 365 days a year, to include weekends, all federal holidays and down days 2.2.

2.3. Transportation of specimens to include all transport supplies. Specimen transport shall be implemented around laboratory schedule. In addition to Monday-Friday pick-ups, Saturday pick-ups should be available upon request. Pick-ups are delivered to the vendor within the same or next day.

2.4. Cover costs of sending specimens on for special consultations at the request of the laboratory, to include all reports from testing performed and any pertinent information to the case. >90% of the tests available should be performed by the company without being sent to a third party reference laboratory.

2.5. Specimen testing services for all tests within current test menu.

2.6. Provide the DGMC Laboratory the scheduled days of testing for the different test procedures with turnaround times listed in paragraphs 3.1-3.8

2.7. Single-site (one lab) specimen testing for easy and safer specimen tracking, for all tests with the exception of Cytogenetic testing.

2.8. The contractor shall incorporate DGMC’s laboratory patient accession numbering sequence on each report for tracking.

2.9. For Cytogenetic testing and/or testing not available, the contractor shall source a laboratory to perform the test and be responsible for shipping specimen to the source laboratory and provide all necessary information from shipment to reporting of results.

2.10. The contractor shall provide DGMC Laboratory with a Web-based result reporting that will allow DGMC Laboratory computers to receive results utilizing a standard Web browser, for example, Internet Explorer. The contractor’s website will also provide timely access to online high-resolution microscopic images, ability to check status of test results, and provide access to historic results which are available on-line indefinitely. The contractor’s website shall provide a password based system in which reports can be accessed by pathologist from any location at any time.

2.11.

2.12. Virtual analysis capability, allowing for slide images of IHCs, Flow Cytometry and FISH tests to be seen on-line that are able to be screened for diagnosis, allowing for immediate review of patient cases, cutting back diagnostic and turn-around time 50-75%. All web-based services should be free of charge with easy access to technical support service representatives.

2.11. Reports should be easily accessible electronically from the web-based reporting system and be downloadble as a PDF file or any format wherein the report can be transferred to the patient’s CoPath file via a “cut and paste” function.

2.13. Provide support to assist laboratory when implementing new in-house tests (such as ER/PR/Her2 for prognostic purposes) or if the pathologist would like to interpret a test. . Company to provide cross correlation studies and information to insure smooth process.

2.14. Access to extensive and experienced medical advisory staff available for consultations. Must include pathologists that have lectured and been published in the fields of breast cancer, soft tissue, immunohistochemistry and hematopathology. Full list of pathologists on staff requested for review.

2.15. Provide a current order requisition form for all available immunohistochemistry (IHCs) and other testing to allow for quick and easy ordering capability . Full list of tests requested for review.

3. SPECIFIC TESTING

3.1. IHC Testing

3.1.1. The contractor shall provide extensive immunohistochemistry technical-only program, to include add-on ordering capability within the system (and interpretive services to include consultations if needed).

· IHC menu should be broad and include multiple IHC to help differentiate between different tumor sites and types. Targeted organ sites include brain, skin, soft tissue, bone, endocrine system, lung, bone marrow, lymph node, gastrointestinal, genitourinary, gynecologic, and hepatobiliary systems.

· For certain tests (androgen receptor, BCL1, BCL2, EGFR, Estrogen Receptor, Her2, Ki-67, MLH1, MSH2, MSH6, p21, p27, p53, PMS2, Progesterone Receptor, and Thymidylate Synthase), the program must provide automated scoring on most cancer markers.

· Company should have PD-L1 testing available.

· Turnaround time for Stain Only, no on-line review: 36 hours from time specimen is received by the contractor (includes slides being returned to DGMC).

· Turnaround time for Stain Only, with Image Analysis, with or without scoring option: 24 hours from time specimen is received by the contractor, the slides will be returned within 2 days.

· Turnaround time for prognostic markers by IHC for breast cancer cases: 48 hours from time specimen is received by the contractor, the slides will be returned within 2 days

3.2. Flow Testing

· The contractor shall provide extensive technical-only and/or interpretative services for flow cytometry. Reports should include complete flow workbook that includes list mode analysis and histograms. Services should include add-on ordering capability within the system and training at company facility by a company hematopathologist if desired.

· Contractor must have capability to do test on “washed” core biopies.

· Turnaround time will be 24 hours from time specimen is received by contractor.

· Turnaround time will be 48 hours for any additional flow testing to be added on.

3.3 PCR and Cytogenetics Testing

· PCR – Turnaround time will be 5 days from time specimen is received by the contractor.

· Cytogenetics – Turnaround time will be 7 to 12 days from time specimen is received by the contractor.

· If PCR or Cytogenetics testing is added on to Flow Test that has already been performed, the time starts from when test is added on.

3.4. FISH Testing

· The contractor shall provide a broad range of tumor-based tests which encompass multiple organ systems and which include but are not limited to breast at least Her2 FISH testing, bladder, lymph node/ hematologic, skin, soft tissue, lung and gastrointestinal systems,

· Turnaround time: 72 hours from time specimen is received by contractor

· FISH testing is added on to a Flow test that has already been performed, the turnaround time starts from when the test is added on.

3.6. Circulating Tumor Cells (plasma-based liquid biopsies for tumor mutations)

· Turnaround time : 2-7 days from time received by contractor.

3.7. Colon and Lung Cancer Panels

· The contractor shall provide KRAS, BRAF and EGFR testing for in the areas of Colon and Lung cancer with methodologies which include cell sensitivity down to 1%. Must have processing which allows for minimal QNS (quantity not sufficient) due to specimen size. Turnaround time: 5-10 days from time received by contractor..

· The contractor shall provide comprehensive lung cancer panel that includes markers from Immunohistochemistry to help differentiate between adeno and squamous in non-small cell lung cancer cases. Turnaround time: 24 hours from time received by contractor.

3.8 Next Generation Sequencing

· The contractor shall provide next generation sequencing (massive parallel sequencing) for solid tumors which encompass a variety (at least 5) organ systems.

· Report should include interpretation of findings, discussion of mutations and clinical implications and recommendations for possible clinical trials.

· An example of a de-identified positive patient report is requested.

· Turnaround time: variable, depends on case complexity

3. SERVICES SUMMARY

This section prescribes how the Government plans to (1) access contractor performance and, (2) manage the contract to obtain efficiencies, improved performance, and cost savings throughout its life cycle.

Must meet 100% of time.

4. GENERAL INFORMATION

4.1 ENVIRONMENTAL CONTROLS

The contractor shall be knowledgeable of and comply with all applicable Local, State, and Federal requirements regarding environmental protection. In the event environmental laws/regulations change during the term of this contract, the contractor is required to comply as such laws come into effect. If there is an increase or decrease in cost as a result of the change, the contractor shall inform the Contracting Officer pursuant to notice requirements and negotiate a modification to the contract.

4.2. Environmental Management System (EMS). Contractors shall perform work under this contract in a manner that is consistent with Travis AFB EMS and conforms to all applicable environmental laws, regulations and policies. Upon awarding of the contract, the Contracting Officer's Representative will direct the Contractor to review and post the Travis EMS Environmental Policy Letter in the workplace and review the EMS Awareness Training slide presentation; both items are located at the Travis AFB Environmental website at http://www.travis.af.mil/enviro. Within seven business days of the start date, the Contractor shall provide the Contracting Officer with a list of names of all employees who viewed the applicable training as well as the date training was completed. The Contractor shall provide information when necessary to demonstrate written conformance with these requirements upon request.

4.3. RECORDS, FILES, DOCUMENTS, DATA AND WORK PAPERS

All records, files, documents, data and work papers provided by the Government remain Government property. The FRED will provide guidance to the HCW who shall maintain and dispose of these records, files and documents in accordance with Air Fore Manual 33-363 and IAW applicable HIPAA requirements as stated in the HIPAA clause. HCWs will comply with all AFMS requirements for safe keeping, handling, release and disposal of any of the above information. These AFMS requirements shall include, but are not limited to: limiting access to government data, tracking information for origin to disposal, removal of personal identifiers and thoroughly destroying information when work is completed in accordance with Federal Law and DoD Regulations.

4.4. FEDERAL HOLIDAYS AND DOWN-DAYS

Federal Holidays

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Days

Thanksgiving Day

Christmas Day

Down-Days

Are posted during the year and a list can be provided to the contractor by the CO, upon request.

Appendix A

Applicable Publications

Publications and forms are available electronically through the internet. For example: http://www.e-publishing.af.mil/ is the Air Force’s e-publishing site and one way to obtain Air Force Instructions. DoD Directives can be found at http://west.dtic.mil/whs/directives/. Regulations are followed by a “-R” (e.g., DoD 5200.-R) and be located on a website by clicking on “publications” instead of “directives”. 60th Medical Group Instructions (60 MDGIs) can be located on the MTF website and can be provided to the contractor upon request.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS INSTRUCTIONS/DIRECTIVES

PUB NO.

TITLE

DoD 5200.01 Information Security Program and Protection of Sensitive Compartmented Information

DoD 5200.2-R

Personnel Security Program

DoDD 5400.11

Privacy Program

DoDD 5500.7 Standards of Conduct

DoDI 5400.7-R Freedom of Information Act

DoD 6025.5 Personal Services Contracts (PSCs) for Healthcare Providers

DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System

DoD 6025.18-R

Health Information Privacy Regulation Jan 03

DoD 6025.40 Military Health System Data Quality Management Controls Procedures

DoD 6040.41 Medical Records Retention and Coding at Military treatment Facilities

DoD 6040-42 Medical Encounter and Coding at Military Treatment Facilities

DoD 6040.42 Custody and Control of Outpatient Medical Records

DoDD 8500.1

Information Assurance

DoD 8580.02-R

HIPAA Security Rule

DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services

DoDI 6040.43

Custody and Control of Outpatient Medical Records

AIR FORCE INSTRUCTIONS/MANUALS

PUB NO.

TITLE

AFI 31-401

Information Security Program Management

AFI 31-501

Personal Security Program Management

AFI 33-119

Air Force Messaging

AFI 33-129

Web Management and Internet Use

AFI 33-200

Information Assurance (IA) Management

AFI 33-202V1

Network and Computer Security

AFI 33-322

Records Management Program

AFI 33-332

The Air Force Privacy and Civil Liberties Program

AFI 33-364

Records Disposition – Procedures and Responsibilities

AFI 34-242

Mortuary Affairs Program

AFI 36-1004

The Air Force Civilian Recognition Program

AFI 36-2201

Air Force Training Program

AFI 36-2910

Line of Duty (Misconduct) Determinations

AFI 36-3002

Casualty Services

AFI 40-102 TRAVISAFBSUP_1

Tobacco Use in the USAF

AFI 40-701

Special Needs Identification and Assignment Coordination

AFI 41-102

Air Force Medical Expense and Performance Reporting Systems (MEPRS) for Fixed Military Medical and Dental treatment Facilities

AFI 41-104

Professional Board and Nation Certification Examinations

AFI 41-106

Medical Readiness Program Management

AFI 41-210

TRICARE Operations and Patient Administration Functions

AFI 44-102

Medical Care Management

AFI 41-117

Medical Service Officers Education

AFI 44-119

Medical Quality Operations

AFI 48-105

Surveillance, Prevention, and Control of Diseases and Conditions of Public Health or Military Significance

AFI 48-110

Immunizations and Chemoprophylaxis for the Prevention of Infectious Diseases

AFI 33-360

Publications and Forms Management

AFMAN 33-152

User Responsibilities and Guidance for Information Systems

AFMAN 33-363

Management of Records

60 MDG/Unit-Specific Operating Instructions/Protocols/Guidelines

MDGT 44-094

Medical Staff Peer Review

MDGI 44-39

Background Investigation of Persons Providing Care to Children

MDGT 44-43

Medical Staff Guide

MDGI 44-61

Emergency Cardiovascular Care (ECC) Program

MDGI 31-02

Notification, Dissemination, Protection, Reproduction, Destruction and Removal of Messages and Classified Information

Publications Code:

AFI--Air Force Instruction

AFMAN--Air Force Manual

AFP--Air Force Pamphlet

AF Form--Air Force Form

DD Form--Department of Defense Form

MDGI – Medical Group Instruction

Appendix B

Standard Abbreviations and Terms

Abbreviation and acronyms

· CC: Commander

· CO: Contracting Officer

· COR: Contracting Officer Representative

· FRED: Functional Requirements Evaluator Designee

· HCW: Health Care Worker.

· MTF: Medical Treatment Facility

· PWS: Performance Work Statement

· QC: Quality Control

· SS: Services Summary

Terms

Commander (CC) - MTF Commander, Flight Commander or other activity head, or a designated representative, e.g., Contracting Officer’s Representative (COR) or Department Head, of the activity designated in contract.

Contracting Officer (CO) – The CO has the overall responsibility for contract administration and is the primary focal point for formal government-contractor interface. The CO is responsible for monitoring contract compliance and resolving disagreements regarding interpretation of contract terms and conditions. The two primary functions of the CO with regard to surveillance are to authorize changes to the contract and to approve payment. Payment is authorized based on documented objective evidence provided by the COR that contractor performance meets the performance standards specified. The CO is also responsible for approving the QASP.

Contracting Officer’s Representative (COR) - A systematic program designed to provide insight into the service provider’s processes. The program focuses on existing data/systems to obtain process improvement and enhance performance.

Contractor - The company identified in block 15A of Standard Form 33. The Contractor is an independent contractor and is responsible for its own liability. Contractor refers to the prime Contractor. The prime Contractor retains responsibility for any teaming partner or subcontractor and shall be accountable for their performance.

Functional Requirements Evaluator Designee (FRED) - Individual/s who are appointed to provide technical surveillance over contracted healthcare workers and who will provide feedback on a regular basis to the COR.

Medical Treatment Facility (MTF) - Air Force hospitals or clinics, including all activities providing outpatient and/or in-patient healthcare services for authorized personnel.

Performance Work Statement (PWS) - The standard of work that describes the core requirements in clear, specific, and objective terms with measureable outcomes.

Services Summary (SS) - Prescribes how the Government plans to (1) assess contractor performance and, (2) manage the contract to obtain efficiencies, improved performance, and cost savings throughout its life cycle.

�Replace with current date.

�Doesn’t flow. Recommend: weekends and all federal holidays and family down days.

�Doesn’t flow. Pick u is to be Mon-Fri or optimal testing? What defines optimal testing?

�What turnaround times? Where are they located? Where below?

�Pick list of all available IHC’s and other testing? Bid schedule should list ALL testing required not a list to pci and choose from. This is a firm fixed price contract not a BPA.

�What is “most comprehensive”? What if a more comprehensive test is developed down the road, is the contractor required to use the new one then? Will the contractor incur additional costs which would in turn be passed on to the Government?

�There is no turn around time listed in paragraphs 2.2 – 2.8.