PWS Anatomic Pathology Services - 10Feb22.pdf

PERFORMANCE WORK STATEMENT

ANATOMIC PATHOLOGY SERVICES

Medical Treatment Facility, David Grant Medical Center

Travis AFB, California

10 Feb 2022

Table of Contents

Section Title

1 Description of Services 3

2 Contractor Responsibilities 3

3 Services Summary 6

4 General Information 7

Appendix A Applicable Publications 8

Appendix B Standard Abbreviations and Terms 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 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, nex 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 agrees to provide the specimen testing services for a minimum of 5 days a week, Monday – Friday, 52 weeks a year with availablity of weekend, AMC Family days and Federal Holiday pick ups, if needed.

2.2. Transportation of specimens to include all transport supplies. Courier pick-ups shall be implemented around laboratory schedule (0730-1630) and pickuped 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. 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 with the exception of some Cytogenetics testing and consultations)

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

2.5. 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. 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. 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

Laboratory Information System via a “cut and paste” function.

2.11. 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.

2.12. 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 in order to support emergency surgeries.

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 sytems.

• 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 (quarterly)

Test Description Quantity IHC Quantitative 150 IHC Morphometric Analysis, using computer aided technology 120 IHC Morphometric Analysis using computer aided technology-Tech 120 IHC by ISH 20 FISH testing 60 Special Stain 24

HPV ISH 24

Flow Cytometry Panel, BM, Global (31) 30 Flow Interpretation (16+ Mkrs) 30 Cytogenetics (Chromosome Analysis 20-25 cells w/Interpretation) 24 BRAF Mutation Analysis by PCR 6 EGFR Mutation Analysis by PCR 10 NGS ALK, NTRK, RET, ROS1 Fusion Profile 6 RAS/RAF Panel 6 Head & Neck Tumor Profile 3 Lymphoma Profile 3 Myeloid Disorders Profile 12 Breast Tumor Profile 3 Lung Tumor Profile 4 Melanoma Profile 4 Ovarian Tumpor Profile 2 Pancreas Tumor Profile 3 Thyroid Profile 3 Liquid biopsy - lung 6 Liquid biopsy - other than lung 12 Professional/Comprehensive consult 12

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 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/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 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 http://www.e-publishing.af.mil/ http://www.e-publishing.af.mil/ http://west.dtic.mil/whs/directives/

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

Appendix B

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 measureable outcomes.