PWS Anatomic Pathology_15 Nov 23_SAM.pdf

PERFORMANCE WORK STATEMENT (PWS)

ANATOMIC PATHOLOGY SERVICES

Medical Treatment Facility, David Grant Medical Center

Travis AFB, California

15 Nov 2023

TABLE OF CONTENTS

Section Title Page 1 Description of Services 3 2 Contractor Responsibilities 3 3 Specific Testing 4 4 General Information 7 5 Services Summary 8 6 Applicable Publications 8 7 Standard Abbreviations & Terms 10

8 HIPAA 10

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 oncology pathology testing services which includes logistics/transportation of specimens, shipping materials, requisition forms and access to a web-based platform reporting system necessary to provide comprehensive tests 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 testing services required include immunohistochemistry (IHC) and special stains, flow cytometry, Fluorescence In Situ Hybridization (FISH), cytogenetics, molecular markers, solid tumor profiling, next genetic sequencing and consultation services.

1.2. 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. The contractor shall provide the specimen testing services for a minimum of 5 days a week, Monday

– Friday, 52 weeks a year with availability of weekend, DHA Down Days and Federal Holiday pick-ups, if needed.

2.2. The contractor shall provide transportation of specimens to include all transport supplies. Courier pick-ups shall be implemented around laboratory schedule (0730-1630) and picked up daily prior to 1630.

As mentioned in section 2.1, weekend and holiday pick-ups will be available upon request. Pick-ups are delivered to the vendor within the same or next day.

2.3. The contractor shall 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. (I.E. Single-site (one lab) specimen testing for easy and safer specimen tracking, for all tests except for some Cytogenetics testing and consultations)

2.4. The contractor shall provide specimen testing services for all tests within current Test Menu.

2.5. The contractor shall provide the DGMC Laboratory the scheduled days of testing for the different test procedures with turnaround times listed in paragraphs 3.1-3.8

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

2.7. For testing temporarily not available due to reagent inventory issues, 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.

2.8. The contractor shall provide a Web-based result reporting that will allow DGMC Laboratory computers to receive results using a standard Web browser. The contractor’s website shall provide timely access to online high-resolution microscopic images, ability to check status of test requested, and indefinite access to historic results. Additionally, the contractor’s website must have a password-based system which can be accessed by the pathologist from any location at any time.

2.9. The contractor shall provide 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.

2.10. The contractor shall provide reports should be easily accessible electronically from the web-based reporting system and be downloadable as a PDF file or any format wherein the report can be transferred to the Laboratory Information System via a “cut and paste” function.

2.11. The contractor shall 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 ensure smooth process.

2.12. The contractor shall provide access to extensive and experienced medical advisory staff available for consultations. Provide list of pathologists on staff as related to the types of testing that we are requesting.

2.13. Provide current order requisition forms that allow for quick and easy ordering for the various methodologies and tests needed.

2.14. Provide 24/7 access to client services to support changes to testing, add-on testing, or rush cases to support emergency surgeries.

2.15 Provide and have available shipping materials and requisition forms.

3. SPECIFIC TESTING

3.1. Anatomic Pathology Services (IHC and Special Stain Testing)

• The contractor shall provide extensive Anatomic Pathology Services to include but not limited to special staining and IHC technical program with 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 for specific cancer types that involve approved therapy options.

• Turnaround time for Stain Only, no on-line review: 72 hours from time specimen is received by the contractor. Slides returned priority overnight.

• Turnaround time for Stain Only, with Image Analysis, with or without scoring option: 72 hours from time specimen is received by the contractor. Slides returned priority overnight.

• Turnaround time for prognostic markers by IHC for breast cancer cases: 72 hours from time specimen is received by the contractor, the slides will be returned within 2 days.

• Company should have special stain testing not performed at DGMC with a turnaround time of 72 hours from the time the specimen is received.

• All slides and materials to be returned to DGMC within 2 days of all testing being completed.

3.2. Flow Cytometry Testing and Panels

• 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.

• Contractor must have capability to do test on “washed” core biopsies.

• 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 Cytogenetics Testing

• The contractor shall provide testing that involves analysis of cells in fluid or tissue sample to identify changes in individual chromosomes that provide diagnostic insights regarding solid tumor cancers and hematologic malignancies.

• Turnaround time will be 6-8 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: 5-7 days from time specimen is received by contractor

• If 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.

3.5. Molecular Testing

• 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.

• NGS Analysis, PCR Analysis and some molecular testing turnaround time will be 5-21* days from time specimen is received by the contractor. *Depending on test ordered

3.6. Hematologic Profiling

• The contractor shall provide qualitative next generation sequencing for the detection of DNA alterations of various myeloid lymphoid disorders and somatic mutations in genes relevant to various solid tumor cancers of a multiple (at least 10) organ systems.

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

• Turnaround time: variable, depends on case complexity

3.7. Liquid Biopsy

• The contractor shall provide plasma testing for lung and solid tumors when the tissue is insufficient, unavailable, or not practical to obtain, or when results are needed more quickly than they can be obtained from tissue analysis.

• Turnaround time: 5-7 days from time received by contractor.

3.8. Workload Estimate for Panels and Tests (Annual) *

Test Description Annual Quantity

(EA)

IHC 120

ISH 60

IHC panels (MMR or Breast Triple, etc) 36 Special Stain 24 Flow Cytometry with Interpretation 40 FISH testing 20 Cytogenetics Study with Interpretation 24 Molecular tests (KRAS/BRAF) 6 Molecular tests (NGS ALK/NTRK) 6 Molecular tests (RAS/RAF Panel) 6 Head & Neck Tumor Profile 3 Lung Tumor Profile 15 Gastric Tumor Profile 1 GI Predictive Profile 1

Melanoma Profile 4 Ovarian Tumor Profile 3 Pancreas Tumor Profile 3 Thyroid Profile 3 Lymphoma Profile 3 Breast Tumor Profile 3 PD-L1 tests 24

Bone Marrow Evaluation with full diagnostic morphology consult 30 Lymphoma Consult 12 Colorectal Cancer Focus Panel 3 InVisionFirst-Lung Liquid Biposy 1 BRCA1 and BRCA 2 Focus Panel 5 NeoTYPE Discovery Profile for Hematologic Cancer 1 Full Focus Cancer Panle (Germline) 25

* Estimates based off previous 12 months usage, this data might not be reflective of current/future needs and testing should not be limited to these quantities. Test availability is per the Official Price List designated by Contracting.

4. GENERAL INFORMATION

4.1. 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.

4.2. FEDERAL HOLIDAYS AND DOWN-DAYS

Federal Holidays New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day

Veterans Days Thanksgiving Day Christmas Day

Down-Days If applicable and granted by a higher authority (eg DHA/Commander), are days where non-essential services are reduced. The Laboratory is a 24/7 operation and in the event of a Down Day, pick-ups will continue to occur according to the schedule as referenced in 2.2.

5. SERVICES SUMMARY

Performance Objective Reference Performance Threshold Weekday Courier Pickup during laboratory hours

Paragraph 2.2 100% of the time

24/7 access to client services Paragraph 2.14 100% of the time 24/7 result access online Paragraph 2.8 100% of the time Meets turnaround times each month

Paragraphs 3.1 - 3.7 100% of the time

Maintains CLIA/CAP accreditation and provides copies to DGMC

Paragraphs 1.2 Must maintain accreditations 100% of the time.

Availability of Shipping Materials and Requisition Forms

Paragraph 2.15 100% of the time

6. 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/MANUALSINSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDM 5200.01 Information Security Program DoDM 5200.2 Procedures for the DoD Personnel Security Program DoD 5400.11-R Privacy Program DoDD 5500.7 Standards of Conduct DoDD 5400.7-R Freedom of Information Act DoDI 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 DoDI 6025.18-R Health Information Privacy Regulation http://www/ http://west/

DoDI 6040.40 Military Health System (MHS) Data Quality Management Controls Program DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities DoDI 6040.42 Management Standards for Medical Coding of DoD Health Records DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DoDD 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 33-129 Web Management and Internet Use AFI 33-202 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 36-2201 Air Force Training Program AFI 36-2910 Line of Duty (Misconduct) Determinations AFI 36-3002 Casualty Services 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 17-1304 Cybersecurity AFMAN 33-152 User Responsibilities and Guidance for Information Systems AFMAN 33-363 Management of Records

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

MDGI 33-10 Health Information Assurance Policy MDGI 44-094 Medical Staff Peer Review MDGI 44-39 Background Investigation of Persons Providing Care to Children MDGI 44-61 Emergency Cardiovascular Care (ECC) Program MDGI 31-02 Security Program Management

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 DoDD – DoD Directive DoDI – DoD Instruction DoDM – DoD Manual MDGI – Medical Group Instruction

7. STANDARD ABBREVIATIONS AND TERMS

Abbreviation and acronyms

• MTF: Medical Treatment Facility

• PCR: Polymerase Chain Reaction

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.

Contractor - 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.

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 measurable outcomes.

8. HIPAA STATEMENT

Health Insurance Portability and Accountability ACT (HIPAA)/Maintenance of Patient Privacy

• The Government shall continue to have exclusive possession, control, and all rights regarding any and all government health information regardless of form or recording media that is used, produced, or derived by the Contractor and its subcontractors in the performance of this contract in the government furnished premises.

• No protected health information shall be removed from the government furnished premises, copied, or transmitted from the government furnished equipment except as expressly authorized by the Government.

The Contractor shall within 3 days return to the Government any and all health information related to its performance of this contract that may come into its possession or control. Until the health information is returned, the Contractor shall protect it in accordance with the Privacy Act of 1974, HIPAA, the privacy regulations of the United States Department of Health and Human Services (DHHS)(42 CFR 160 and 164), and Department of Defense Regulation 6025.18-R. Additionally, the Contractor shall not disclose any health information to anyone except as expressly authorized by the Government, and it shall include these information protection requirements in any and all of it subcontracts related to the performance of this contract. The Contractor and its subcontractors shall also comply with all of the following general requirements of HIPAA that may be more protective of government health information than this contract.

• Except as otherwise limited in this Agreement, 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.

• Except as otherwise limited in this Agreement, 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.

• The Contractor shall immediately notify the Government about any use or disclosure of health information permitted by federal privacy regulations and this contract.

• The Contractor shall have written agreements with all its subcontractors in the performance of this contract, which shall include these HIPAA requirements and any information protection requirements of this contract.

• The Contractor shall allow the U.S. Department of Health and Human Services access to the Contractor’s books, practices, and records relating to health information in the Contractor’s possession or control pursuant to this contract.

• The Contractor shall return any and all health information in its possession or control to the Government after termination of this contract for any reason or completion of the term of this contract and any and all extensions.

• A breach by the Contractor of this clause may subject the Contractor to termination under any applicable default or termination provision of this contract.