36C25524R0061_1Amendment1.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C25524R0061 08-01-2024

Mike Carson; michael.carson1@va.gov 913-946-1119 09-03-2024

17:00 CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X 100

X

Y

621111

$16 Million

N/A

John Cochran VA Medical Center 915 Grand Blvd.

St. Louis MO 63106

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15

36C255

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

This solicitation is for non-personal services for on-site Radiation Oncology Physician Services during regular work hours, as defined in this solicitation and Performance Work Statement (PWS).

This requirement is being solicited under 38 U.S.C 8153 and Veterans Affairs Acquisition Regulation (VAAR) 873.

Schedule of Services begins on page _. Performance Work Statement begins on page __.

These services will be performed at the John Cochran VA Medical Center (VAMC) in St. Louis, MO.

See CONTINUATION Page

Mike Carson

VA-VHA-RPOC-2023-0085

36C25524R0061

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (JAN 2011)

C.4 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (NOV 2021)

C.5 52.216-18 ORDERING (AUG 2020)

C.6 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.8 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.9 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...57

C.10 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN

1997)

C.11 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.12 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.13 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.14 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.15 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.16 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.17 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.18 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.19 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.20 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.21 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.22 VAAR 852.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (OCT 2019)

C.23 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.24 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.25 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..78

C.26 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 VAAR 852.273-73 EVALUATION - HEALTH-CARE RESOURCES (NOV 2021)

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.6 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES—

REPRESENTATION (OCT 2020)

E.7 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.8 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.9 52.216-1 TYPE OF CONTRACT (APR 1984)

E.10 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.11 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020)

E.12 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.13 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.14 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.15 VAAR 852.273-70 LATE OFFERS (NOV 2021)

E.16 VAAR 852.273-71 ALTERNATIVE NEGOTIATION TECHNIQUES (NOV 2021) 105

E.17 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.18 52.207-3 RIGHT OF FIRST REFUSAL OF EMPLOYMENT (MAY 2006)

E.19 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C255 Mike Carson Department of Veterans Affairs Network Contracting Office (NCO) 15

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Invoices shall be submitted MONTHLY, in arrears

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Invoicing shall be in accordance with the requirements of The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

1 8/9/2024 http://www.fsc.va.gov/einvoice.asp

B.2 SCHEDULE OF SERVICES

The Contractor shall furnish all key personnel to provide services necessary to perform onsite Radiation Oncology Physician to eligible beneficiaries of the Department of Veterans Affairs, St.

Louis VAMC – John Cochran. A contractor providing on-site radiation oncology services must provide evidence the radiation oncology practice meets or exceeds the established clinical practice guidelines and standards.

All VHA Radiation Oncology Services are accredited by a nationally recognized accrediting body contracted through the National Radiation Oncology Program (NROP). As such any Contractor providing on-site radiation oncology services must adhere to all the policies and procedures; practice standards, guidelines, patient care operations; patient safety; quality assurance and quality management of radiotherapy planning, equipment, and delivery; and continuous quality improvement initiatives promulgated by the American College of Radiology, American Society for Radiation Oncology and American Association for Physicist in Medicine.

Place of Performance: Services shall be provided on site in Radiation Oncology Service, John Cochran VA Medical Center (VAMC) – VA St. Louis Healthcare System (VASTLHCS), 915 North Grand Blvd, St. Louis MO 63106-1621.

This is a Fixed Price, Indefinite Delivery Indefinite Quantity (FP-IDIQ) solicitation since it is impossible to determine with any certainty the amount of services that will be required under this contract. The period of performance for this contract will be a Base Year plus four (4) option years. There is no guarantee that option years will be exercised. The overall minimum value of services and overall maximum value of services to be provided under this contract are as follows:

A. The prices provided in the Price Schedule shall be inclusive of all Line Items defined in the PWS.

B. In accordance with FAR Clause 52.216-22, Indefinite Quantity, the guaranteed minimum contract amount is $1,000.00 applicable during the base period of the fiscal year in which the award is made and the total maximum amount shall not exceed $5,500,000.00 over the life of the contract.

Pricing Instructions:

The offeror is instructed to edit the number of Sub-Line Items (SLIN) to correspond with the number of key personnel submitted for the line item number (LIN). Affiliate Offerors shall include the “title” of the personnel submitted. Other commercial health care Offerors shall identify by title/position or level of experience the key personnel submitted. Also, renumber SLINs if adding or removing Key Personnel.

The Contractor shall propose a minimum of two (2) key personnel for LIN 0001 to be credentialed and be available for scheduling to meet the requirements of the contract.

Task Order Issuance Procedures:

The terms that apply to the issuance of Task Orders under this contract are set forth below:

Once a need arises, the Contracting Officer or his/her authorized designated Contracting Officer Representative (COR) will notify the contractor that a requirement exists. The Contracting Officer will then issue a task order. Orders may be issued electronically via e-mail, facsimile, or other authorized electronic means. The performance period for performance shall be set forth in each task order. Task order shall not exceed the total amount obligated. The total amount of all task orders shall not exceed as provided in FAR Clause 52.216-19(b)(2).

Period of Performance: BASE: November 01, 2024 to October 31, 2025

LIN

No. SLIN

Description Estimated Qty. Unit Unit Cost

Estimated Total

Annual Cost

0001 None Board Certified Radiation Oncology Physician Services 2080 HR

KEY PERSONNEL

0001a

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

0001b

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

ESTIMATED TOTAL FOR BASE YEAR: $____________________

OPTION YEAR 1: November 01, 2025 to October 31, 2026

LIN

No. SLIN

Description Estimated Qty. Unit Unit Cost

Estimated Total

Annual Cost

1001 None Board Certified Radiation Oncology Physician Services 2080 HR

KEY PERSONNEL

1001a

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

1001b

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

ESTIMATED TOTAL FOR OPTION YEAR 1: $____________________

OPTION YEAR 2: November 01, 2026 to October 31, 2027

LIN

No. SLIN

Description Estimated Qty. Unit Unit Cost

Estimated Total

Annual Cost

2001 None Board Certified Radiation Oncology Physician Services 2080 HR

KEY PERSONNEL

2001a

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

2001b

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

ESTIMATED TOTAL FOR OPTION YEAR 2: $____________________

OPTION YEAR 3: November 01, 2027 to October 31, 2028

LIN

No. SLIN

Description Estimated Qty. Unit Unit Cost

Estimated Total

Annual Cost

3001 None Board Certified Radiation Oncology Physician Services 2080 HR

KEY PERSONNEL

3001a

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

3001b

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

ESTIMATED TOTAL FOR OPTION YEAR 3: $____________________

OPTION YEAR 4: November 01, 2028 to October 31, 2029

LIN

No. SLIN

Description Estimat ed Qty. Unit Unit Cost

Estimated Total

Annual Cost

4001 None Board Certified Radiation Oncology Physician Services 2080 HR

KEY PERSONNEL

4001a

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

____ HR $______hr. $_________

4001b

Board Certified Radiation Oncology Physician

NAME: ____________

TITLE: ____________

NPI:______________

LEVEL OF EXPERIENCE:

ESTIMATED TOTAL FOR OPTION YEAR 4: $____________________

ESTIMATED TOTAL CONTRACT: $____________________

B.3 PERFORMANCE WORK STATEMENT

1. GENERAL

1.1 SERVICES REQUIRED: The VA Radiation Oncology Services are accredited by a nationally recognized accrediting body contracted through NROP. As such any Contractor providing on-site radiation oncology services must adhere to Guidelines & Technical Standards for Radiation Oncology promulgated by the American College of Radiology, American Society for Radiation Oncology and American Association for Physicist in Medicine: A contractor providing on-site radiation oncology services must provide evidence the radiation oncology practice meets or exceeds the established clinical practice guidelines and standards.

1.2. PLACE OF PERFORMANCE: Contractor shall furnish services at the St. Louis VAMC – John Cochran, 915 North Grand Blvd, St. Louis MO 63106-1621.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority VAAR 873 procedure findings.

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.9. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.10. VHA Directive 1605.01: Privacy and Release of Information

1.4.11. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.12. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

1.4.13. VHA Directive 1156 Accreditation of VHA Radiation Oncology Services/Sections

1.4.14. VHA Directive 1414 Stereotactic Body Radiotherapy

1.4.15. Privacy Act of 1974 (5 U.S.C. 552a) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm https://www.va.gov/vapubs/ https://www.va.gov/vhapublications/index.cfm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.16. US Nuclear Regulatory Commission for management and use of radioactive materials for medical use and radiation safety requirements, to include (but not limited to) 10 CFR Parts 19, 20, 30, 33, 35, and 71:

http://www.nrc.gov/reading-rm.html

1.5. ACRONYMS/DEFINITIONS:

1.5.1. AAPM: American Association of Physics in Medicine

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ABR: American Board of Radiology

1.5.4. ACR: American College of Radiology

1.5.5. ACO: Administrative Contracting Officer

1.5.6. ALARA: As Low as Reasonably Achievable (least & lowest radiation exposure possible)

1.5.7. AOA: American Osteopathic Association

1.5.8. ARRT(T): American Registry of Radiologic Technologists (T) in Radiation Therapy

1.5.9. ASTRO/APEx: American Society for Radiation Oncology/Accreditation Program for Excellence ® (https://www.astro.org/Daily-Practice/Accreditation)

1.5.10. BAA: Business Associate Agreement

1.5.11. CAMPEP: Commission on Accreditation of Medical Physics Educational Programs (http://www.campep.org/default.asp)

1.5.12. CDC: Centers for Disease Control and Prevention

1.5.13. CEU: Certified Education Unit

1.5.14. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.5.15. CMD: Certified Medical Dosimetrist

1.5.16. CME: Continuing Medical Education

http://www.nrc.gov/reading-rm.html http://www.campep.org/default.asp

1.5.17. CMS: Centers for Medicare and Medicaid Services

1.5.18. CO: Contracting Officer

1.5.19. COR: Contracting Officer’s Representative

1.5.20. COS: Chief of Staff

1.5.21. CPARS: Contractor Performance Assessment Reporting System

1.5.22. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.23. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience or other qualifications.

1.5.24. DEA: Drug Enforcement Agency

1.5.25. EHR: Electronic Health Record – electronic health record system used by the

VA

1.5.26. FSMB: Federation of State Medical Boards

1.5.27. FTE: Full Time Equivalent VA’s standard definition is for full time working the equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.28. HHS: Department of Health and Human Services

1.5.29. HICPAC: Healthcare Infection Control Practices Advisory Committee- a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.

1.5.30. HIPAA: Health Insurance Portability and Accountability Act

1.5.31. IGRT: Image Guided Radiation Therapy is the process of frequent two and three-dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan.

1.5.32. IMRT: Intensity Modulated Radiation Therapy is the process of delivering highly conformal radiotherapy to the tumor while sparing the surrounding normal tissues by varying radiation intensity across treatment portals.

1.5.33. IROC: Imaging and Radiation Oncology Core

1.5.34. ISO: Information Security Officer

1.5.35. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.36. MU: Monitor Unit is a measure of machine output of a linear accelerator in radiation therapy.

1.5.37. NHPP: National Health Physics Program- NHPP provides regulatory oversight for the Nuclear Regulatory Commission master materials license issued to VHA to include permitting for use of materials, on-site inspections, and investigations of allegations, medical events, and incidents. In addition, we provide oversight for machine sources of ionizing radiation used for radiation therapy. Finally, we provide assistance and technical information for uses of ionizing radiation for healthcare diagnosis and treatment and non-human biomedical research.

(http://www.patientcare.va.gov/NHPP.asp)

1.5.38. NPI: National Provider Identifier. NPI is a standard, unique 10-digit numeric identifier required by HIPPA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers)

1.5.39. NROP: National Radiation Oncology Program

1.5.40. NRSC: National Radiation Safety Committee

1.5.41. POP: Period of Performance

1.5.42. PPD: Purified Protein Derivative

1.5.43. PWS: Performance Work Statement

1.5.44. QASP: Quality Assurance Surveillance Plan

1.5.45. QMP: Quality Management Program

1.5.46. SPE: Senior Procurement Executive

1.5.47. SRS: Stereotactic Radio Surgery: a minimally invasive form of surgical intervention which makes use of a three-dimensional coordinated system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery (SRS) etc.

1.5.48. SBRT: Stereotactic Body Radiotherapy

1.5.49. TJC: The Joint Commission

1.5.50. TLD: Thermoluminescent Dosimeter- a device that measures radiation dose

1.5.51. TMP: Therapeutic Medical Physicist

1.5.52. TRT: Therapeutic Radiologic Technologist (Interchangeable Names: Radiologic Therapy Technologist, Radiation Therapist) http://www.patientcare.va.gov/NHPP.asp

1.5.53. VA: Department of Veterans Affairs

1.5.54. VetPro: Is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.55. VHA: Veterans Health Administration

1.5.56. VISN: Veterans Integrated Services Network

1.5.57. VistA: Veterans Information Systems Technology Architecture

2. QUALIFICATIONS:

2.1. License: Contract physician(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia.

All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Contract physician(s) who have current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.2. Board Certification: All contract physician(s) shall be board certified. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.2.1. Radiation Oncology Physician: The Contractor shall provide American Board of Radiology (ABR) certified physicians in the area of Radiation Oncology and contract physicians shall maintain certification throughout the period of performance. In the event that Contractor’s Radiation Oncology Physician(s) is/are not directly employed by the treating facility, documentation must be provided to ensure adequate certification.

2.3. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Directive 1100.20 and VHA Directive

1100.21 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract physician(s) prior to obtaining approval by the Facility Medical Executive Board and Medical Center Director.

2.3.1. If a contract physician(s) and/or other contract provider(s) are not credentialed and privileged or have credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute approved by the government without any additional cost to the government.

2.4. Board Certified Radiation Oncology Physician Qualifications:

2.4.1. Must have MD/DO, graduated radiation oncology residency, board certified in radiation oncology from the ABR with a minimum of five (5) years clinical experience excluding residency. RO must also have the following expertise and knowledge on the following procedures, equipment and software:

2.4.1.1. 3D – Conformal Radiation Therapy (3D-CRT)

2.4.1.2. Intensity Modulated Radiation Therapy (IMRT)

2.4.1.3. Stereotactic Body Radiation Therapy (SBRT): minimum case experience of 10 documented cases within the last two years.

2.4.1.4. Stereotactic Radiosurgery (SRS): minimum case experience of 10 cases documented cases within the last two years.

2.4.1.5. Experience using Varian ARIA and Eclipse Treatment Planning System

2.4.2. Technical Proficiency: Contract physician(s) and other contract provider (s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed.

Contractor’s physicians and other contract provider (s) shall have knowledge of professional care theories, principles, practices, and procedures to serve radiation oncology patient population. Contractor’s physician and other contract provider (s) shall demonstrate knowledge of growth and development, and pathophysiology of disease processes specific radiation oncology patient population. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract physician(s) and other contract provider (s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.5. Continuing CME Radiation Oncologist Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contractors registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. CME hours shall be reported to the credential’s office for tracking. These documents are required for initial and renewal privileging. Failure to provide shall result in loss of privileges.

2.6. Training BLS (Physicians only), EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. Other training may become required. VA will communicate any changes to the training requirement to the contractor.

Training (The following training is mandatory per VHACO for Contracted Physicians)

Frequency (once a year, etc.)

Annual Hours

BLS 4 1 hour

Active Threat Training 1 1 hour

Blood Administration:

Complications

Blood Administration:

Administration (all contract employees who administer blood components)

1 1 hours

EHR 1 3 hour

Government Ethics 1 1 hour

Hospice and Palliative Care for VA Clinicians

1 0.75 hour

Military Sexual Trauma (MST) for Medical Providers

1 1 hour

Moderate Sedation In- Service Training

1 2 hours

PACT Act 2022 Toxic Exposure Screening (TES)

1 0.5 hour

Patient Abuse 1 0.25 hour

Patient Rights 1

Patient Safety 1 1 hour

Prevention/Management of Disruptive Behavior/Violence Prevention Level I

1 1 hour

Prevention of Workplace Harassment/No Fear Act

1 0.5 hour

Suicide Prevention: Suicide Risk Management Training for Clinicians

1 1 hour

SUX Infection Control and Blood Borne Pathogens

VA Core Values Training (ICARE Recommitment)

1 0.5 hour

VA Privacy and Information Security Awareness and Rules of Behavior

1 1 hour

VHA MRI Safety Training Level 1 Training (all who enter MRI suites)

1 0.5 hour

VHA Privacy and HIPAA Focused Training

1 1 hour

VISTA Imaging 1 1 hour

2.7. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC.):

Contractor shall provide proof of the following for physicians within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

2.7.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractor’s physician(s) upon hire in accordance with CDC guidance. (This is applicable to all health care workers). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results.

2.7.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.7.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor physicians {This is applicable to all health care workers}.

2.7.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor physicians {This is applicable to all health care workers}.

2.7.5. INFLUENZA: Contractors shall provide proof that all Contractor physicians have received the annual Influenza vaccine unless it is contraindicated. If the Contractor physician has a medical contraindication to the vaccine, they shall be required to wear a mask during the Influenza season. {This is applicable to all health care workers}.

2.7.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO

BLOODBORNE PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor’s physician(s) {This is applicable to all health care workers}; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.7.7. The facility shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

2.8. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.9. DEA: Contractor shall provide copy of current DEA certificate.

2.10. Conflict of Interest: The Contractor and all contract physician(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest - and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.11. Citizenship related Requirements:

2.11.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.11.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.11.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.11.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.11.5. The Contractor agrees to obtain a similar certification from its subcontractors.

The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.12. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.12.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contract physician(s) is not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.12.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.13. Clinical/Professional Direction: The qualifications of Contractor personnel are subject to review by VA Medical Center COS or his/her clinical designee and approval by the Medical Center Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional direction of all clinical personnel covered by this contract will be provided by the facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.14. Non-Personal Healthcare Services: The parties agree that the Contractor and all contract physician(s) and other contract provider (s) shall not be considered VA employees for any purpose.

2.15. Inherent Government Functions: Contractor and Contract physician(s) and other contract provider (s) shall not perform inherently governmental functions.

This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the http://oig.hhs.gov/exclusions/index.asp interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.16. No Employee Status: The Contractor shall be responsible for protecting Contract physician(s) and other contract provider (s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.16.1. Professional liability insurance

2.16.2. Health examinations to meet requirements in 2.7 STANDARD

INFECTION CONTROL MEASURES (PPD, IMMUNIZATONS, ETC)

2.17. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract physician(s) and other contract provider (s). When a Contractor or contract physician(s) and/or other contract provider (s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract physician(s) or other contract provider (s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.18. Key Personnel:

Contractor shall provide the number of qualified staff as is necessary to perform the services required under this contract, at the staffing level determined to be professionally acceptable by the Facility Chief of Staff and in accordance with American College of Radiology staffing guidelines.

2.18.1. The VA Full Time Equivalency (FTE): FTE for the services required is one (1).

2.18.2. The minimum number of Board-Certified Radiation Oncology physicians required to be on site on a daily basis is one (1) as defined in paragraph Hours of Operation in this section.

2.18.3. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations and additional coverage as required. In the event a scheduled physician is unable to complete an assigned shift, the contractor shall provide replacement physician coverage within 2 hours and notify the Contracting Office Representative (COR) immediately of the schedule change. The Chief of Radiation Oncology will have final call on whether the replacement is necessary for the shift.

2.19. Emergency Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions.

2.19.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes.

The contract will be modified to reflect any approved changes of key personnel.

2.19.2. For temporary substitutions where the key person shall not be reporting to work for 10 consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

2.19.3. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives.

Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contract physician(s), s/he may request, without cause, immediate replacement of said contract physician(s).

2.19.4. The CO and COR shall deal with issues raised concerning Contract physician(s) conduct. The final arbiter on questions of acceptability is the CO.

2.20. Contingency Plan: Continuity of care and uninterrupted operations of a Radiation Oncology Program are essential components of this contract and will be primary factors in Contractor’s assignment of staff and frequency of substitutions. The Contractor shall have a contingency plan in place to be utilized if the contract physician(s) and other contract provider (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract

3. VA HOURS OF OPERATION/SCHEDULING:

3.1. VA Business Hours: 7:00am – 4:30pm CST

3.2. Work Schedule: 7:30am – 4:30pm CST, no more than eight (8) hours a day.

3.2.1. Patients must be seen by a contract physician(s) on-site at Facility in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

3.2.2. Contract Physicians shall be available and present in clinic during normal Facility clinic hours, and may be revised, as deemed appropriate for patient care by the Chief of Staff. Currently, normal clinic hours are Monday through Friday, 7:30 a.m. to 4:30 p.m.

3.2.3. Off-hours Coverage: Off hours and on call coverage is not required for this contract.

3.2.4. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs (no services will be required on below listed days):

• New Year’s Day

• President’s Day

• Martin Luther King’s Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared to be a national holiday.

3.2.5. Cancellation/Rescheduling: Unless a state of emergency has been declared, the Contractor shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

4.1. SERVICES REQUIRED: 2080 hours/1FTE Radiation Oncologist per year.

4.2. Standards of Practice: The medical practice and patient care provided by Contractor shall be evidence based best practices that meet or exceed all standards of professional practice and performance measures applicable to (Facility) medical professionals, including, but not limited to, NHPP, AAPM and TJC standards and national recognized accrediting body current practice guidelines in radiation oncology.

Contractor’s care shall cover the range of services as would be provided in a state-of-the-art civilian medical treatment facility. Contractor shall provide evidence the Contractor’s radiation oncology standard of care is of a quality that meets or exceeds currently recognized VA and nationally recognized accrediting body national standards as established by:

4.2.1. Applicable Radiation Oncology practice guidelines and standards promulgated by ACR, ASTRO, and AAPM.

4.2.2. The professional standards of the TJC or equivalent accreditation:

http://www.jointcommission.org/standards_information/hap_requirements.aspx http://www.jointcommission.org/standards_information/hap_requirements.aspx

4.2.3. The requirements contained in this PWS.

4.3. MEDICAL RECORDS

4.3.1. Authorities: Contract physician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.3.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.3.4.

4.3.3. Disclosure: Contract physician(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract; however, Contractor shall obtain permission from the VA before disclosing any patient information outside VA.

VA authorizes the Contractor to discuss patient health information for coordination of care within community health care providers in compliance with VA regulations, HIPAA, and VHA Directive 1605.1, Privacy and Release of Information.