S02 36C10X24R0038 MLRM External Clinical Review BPA.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

TBD

36C10X24R0038 06-03-2024

Chris Binkley Christopher.binkley@va.gov 07-02-2024

1000 EDT

36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

X

813920

Small Business $23.5 million

N/A

X

See B.2 Performance Work Statement

36C10X

Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section A.3 Contract Admin Data) Austin TX 78714-8917

1-(877)-489-6135

See CONTINUATION Page

The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Medical-Legal Risk Management (MLRM) External Clinical Review Blanket Purchase Agreement (BPA)

See Section E for all instructions associated with this solicitation.

Proposal Submissions due 7/02/2024 at 10:00 AM ET.

Questions: Submit all Questions by 06/11/2024 at 10:00 AM ET.

See CONTINUATION Page

X X

Caitlin Ruc Contracting Officer

36C10X24R0038

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

B.3 IT CONTRACT SECURITY

B.4 PRICE/COST SCHEDULE

B.5 BPA ORDERING PROCEDURES

SECTION C - CONTRACT CLAUSES

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

COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.5 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020)

C.6 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (JAN 2023) (DEVIATION)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) . 66

C.9 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (FEB 2024)

C.12 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 FAR 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT

2018)

E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.11 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

36C10X24R0038 | MLRM External Clinical Review BPA

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: TBD

b. GOVERNMENT: Strategic Acquisition Center - Frederick

Contracting Officer: Caitlin Ruc Email: Caitlin.Ruc@va.gov Phone: 202-281-0997

Contract Specialist: Christopher Binkley Email: Christopher.Binkley@va.gov Phone: (832) 260-2563

COR: Megan Carey Email: Megan.Carey@va.gov Phone: (202) 461-7638

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] Within 30 days upon delivery and acceptance by the

Government

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.

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

AMENDMENT NO DATE

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL mailto:Caitlin.Ruc@va.gov mailto:Christopher.Binkley@va.gov mailto:Megan.Carey@va.gov

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Purchase Order Number: TBD (please include this on all invoices)

Vendor Electronic Invoice Submission Methods:

Fax, email, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted data transmissions below.

• VA’s Electronic Invoice Presentment and Payment System – The Financial Services Center (FSC) in Austin, TX uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten- network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

• A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site is http://www.x12.org.

Vendor e-invoice Set-up information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center in Austin, TX for payment processing. If you have questions about the payment status of a properly submitted invoice, the e-invoicing program, or Tungsten, please contact the FSC at the phone number or email address listed below.

• Tungsten e-Invoice setup information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@tungsten-network.com

• VA TUNGSTEN Number: AAA544240062

• FSC e-Invoice contact information: 1-877-353-9791

• FSC e-Invoice email: vafsccshd@va.gov

• http://www.fsc.va.gov/einvoice.asp

COMMUNICATIONS:

• https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-electronic-submission-of-payment-requests

• http://fcw.com/articles/2012/11/27/va-epayments.aspx?s=fcwdaily

FINAL INVOICE SHALL BE MARKED FINAL

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@tungsten-network.com mailto:vafsccshd@va.gov http://www.fsc.va.gov/einvoice.asp https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-%20lectronic-submission-of-payment-requests https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-%20lectronic-submission-of-payment-requests https://www.federalregister.gov/articles/2012/11/27/2012-28612/va-acquisition-regulation-%20lectronic-submission-of-payment-requests http://fcw.com/articles/2012/11/27/va-epayments.aspx?s=fcwdaily

B.2 PERFORMANCE WORK STATEMENT

1. Introduction

1.1 Background

As the largest Federal provider of health care, the Veterans Health Administration’s (VHA) peer review program is a critical element of quality management and demonstrates the Agency’s commitment to providing the highest quality care possible for Veterans. To keep compliant with VHA Directive 1190 (Peer Review for Quality Management 11/21/2018) and VHA Directive 1099 (Medical Advisory Opinion Requests by General Counsel, 4/22/2020) and to foster a process for improving the rigor and objectivity of peer review, VHA seeks a national Contractor with proven expertise in performing peer review across all provider disciplines.

1.2 Scope

The Contractor shall provide external expertise and conduct a peer review of selected episodes of care. The Contractor shall use the provided platform (Electronic Health Record) for the review of medical records and report templates.

Under this Blanket Purchase Agreement (BPA), the Contractor shall perform the following:

• Peer Review for Quality Management o Audits o Facility Request Reviews

• Management Review o Management Review o Clinical Appeals

• Medical Advisory Opinions

• Executive Summaries

• Reports

• Inter-Rater Reliability (IRR) Studies

For each BPA Call Order, the Contractor shall provide staff to perform the services requested, comprehensive management, and supervision of contractor resources, and any required deliverables.

1.3 Estimated Reviews Per Year

The Government estimates 7,700 reviews per year, according to VHA's needs. The estimated target number of annual reviews per category is listed below:

• Peer Reviews o Approximately 4,300 Audit Reviews o Approximately 1,000 Facility-Requested Reviews

• Management Reviews o Approximately 700 Routine Management Reviews o Approximately 5 Clinical Appeals

• Medical Advisory Opinions o Approximately 1,700 Medical Advisory

Opinions

• Executive Summaries o Approximately 5 Executive Summaries

1.4 Applicable Documents \ References

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the most current versions or superseding publications of the following:

• 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002”

• 38 U.S.C. § 5705, “Confidentiality of Medical Quality Assurance Records” and its implementing regulations Title 38 Code of Federal Regulations §§ 17.500 through 17.511

• 38 U.S.C. § 7332, “Confidentiality of Certain Medical Records”

• 38 U.S.C. § 5701, “Confidential Nature of Claims”

• 38 U.S.C. § 5705, “Confidentiality of Medical Quality Assurance Records”

• Privacy Act and the Health Insurance Portability and Accountability Act of 1996

(HIPAA)

• Public Law 109-461, § 5725, “Contracts for Data Processing or Maintenance”

• Federal Information Processing Standards (FIPS) Publication 140-3, “Security Requirements For Cryptographic Modules”

• FIPS Pub 201-3, “Personal Identity Verification (PIV) of Federal Employees and Contractors,” January 2022

• 10 U.S.C. § 2224, "Defense Information Assurance Program"

• 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

• 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

• Department of Veterans Affairs (VA) Directive 0710, “Personnel Security and Suitability Program,” June 04, 2010

• VA Directive 6102, “Internet and Intranet Services,” August 5, 2019

• 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” February 20, 2001

• OMB Circular A-130, “Managing Information as a Strategic Resource,” July 28,

• An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

• Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7,

• Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

• VA Directive 6500, Managing Information Security Risk: VA Information Security Program, September 20, 2012

• VA Handbook 6500, Risk Management Framework for VA Information Systems– Tier 3: VA Information Security Program, March 10, 2015

• VA Handbook 6500.1, Electronic Media Sanitization, November 03, 2008

• VA Handbook 6500.2, Management of Data Breaches Involving Sensitive Personal Information (SPI), July 28, 2016

• VA Handbook 6500.3, Certification and Accreditation of VA Information Systems, February 03, 2014

• VA Handbook, 6500.5, Incorporating Security and Privacy in System Development Lifecycle, March 22, 2010

• VA Handbook 6500.6, “Contract Security,” March 12, 2010

• VA Technical Reference Model (TRM) (reference at VA Technical Reference Model)

• National Institute Standards and Technology (NIST) Special Publications

• VA Directive 6508, Implementation of Privacy Threshold Analysis and Privacy Impact Assessment, October 15, 2014

• VA Directive 6300, Records and Information Management, October 22, 2018

• VA Handbook, 6300.1, Records Management Procedures, March 24, 2010

• VHA Handbook 1100.17, National Practitioner Data Bank (NPDB) Reports, December 28, 2009.

• OMB Memorandum, “Transition to IPv6”, September 28, 2010

• VHA Directive 1099, VHA Medical Advisory Opinion Requests by Regional Counsel, April 22, 2020

• Federal Rules of Civil Procedure

• VHA Directive 1190, Peer Review for Quality Management, November 21,

• VHA Directive 1041, Appeal of VHA Clinical Decisions, September 28, 2020

• VHA Directive 1083, Notification of Medical Malpractice (Tort) Claims to Involved Staff and Notice of Employment Status to Office of General Counsel, February 9, 2023

• VHA Directive 1093, Delegation of Authority to Process Tort Claims, May 21,

• VHA Directive 1099, VHA Medical Advisory Requests by General Counsel, April 22, 2020

2.0 Task Requirements

2.1 Peer Review for Quality Management Review

A Peer Review for Quality Management is a critical review of care performed by a peer performed in accordance with all applicable laws, regulations, current VHA and VA policies, and VHA Directive 1190, or any superseding directives. Essential elements of Peer Review for Quality Management include:

• Peer evaluation of the care provided by individual clinicians within a selected episode of care.

• Identification of learning opportunities for practice improvement and any related improvement actions recommended by the peer review process.

• Confidential communication back to the clinicians who were peer reviewed regarding the results and any recommended actions to improve their clinical practice. This communication cannot include the initiation of any administrative actions (e.g., modification of clinical privileges).

• Identification of system and process issues that may need to be changed.

Peer Reviews shall be performed by providers in all identified specialties and subspecialties as described in Attachment A - Specialties, with a panel of sufficient size in each discipline to meet the volume and demand of VHA (see Historical Data, Attachment A1). The review panel shall include non-physician Providers, such as Physician Assistants (PA), Advanced Practice https://www.oit.va.gov/Services/TRM/SearchPage.aspx https://www.oit.va.gov/Services/TRM/SearchPage.aspx

Nurses (APRN), Certified Registered Nurse Anesthetists (CRNA), Psychologists, Pharmacists, Registered Nurses, Licensed Vocational Nurses, Social Workers, and other providers.

Depth in key specialties such as Cardiothoracic Surgery, Interventional Cardiology, Vascular Surgery, Neurosurgery, Oncology, Ortho-Spine, and Mental Health is critical to meeting the needs of VHA.

All specialties must have at least 1 reviewer and must have a depth that is reasonably sufficient to maintain the workload provided for all review and specialty categories.

Panel Requirements are subject to change based on emerging practices.

Intermittently, a specialty may be in higher, immediate demand due to Government need.

The Contractor shall have a strategy for expanding the panel size to meet emerging practices, such as transplant services.

The Contractor shall provide a roster of all reviewers (listing status, name, credential, and any specialties, subspecialties, or dual board certifications), and any specialty vacancies. The Contractor shall provide a new list monthly to identify added reviewers and attestation of the Health and Human Services Office of Inspector General List of Excluded Individuals and Entities (LEIE). Documentation of each reviewer’s screen through the LEIE is required upon hire and then monthly.

• Status definitions:

o Active – able to login to the VA network, able to log in to JLV, a current working PIV card, and able to start a case at the time of assignment.

o Inactive – fully onboard yet unable to access VA network or JLV due to an extended time (more than 28 days) of not logging in.

o Pending – onboarding, in progress with a background check, VA account creation, PIV card receipt, and orientation by the vendor.

o Leave of Absence – a temporary break from working for this contract.

o Removed – permanently no longer working for this contract.

Medical Records that do not originate at a VA facility may need to be evaluated to effectively review a case.

On a case-by-case basis, there may be administrative reasons to extend a deadline for a review. The Government will notify and modify dates if the need arises.

On a case-by-case basis, there may be a need for a Modified Document Request. This occurs when there are additional questions or explanations in a written review provided after it has been accepted by the Government. This level of oversight shall be considered part of the quality assurance process. If such a review is initiated, resolution is required within 10 business days. If the clarification request occurs more than 30 business days after the original case was accepted or are more than five (5) questions, the Government has the discretion to order a new case.

All cases receive secondary consideration from the facilities in which they derive. If that facility requests additional consideration due to perceived inaccuracies, a reconsideration at the cost of the vendor is required.

The vendor shall access the patient record in Joint Longitudinal Viewer (or like system). The vendor shall verify the credentials and specialty of the provider under review for each case before assigning a reviewer. Any incompatible peer matches shall be reported as part of the quality assurance surveillance plan.

Medical Advisory Opinions are protected from legal discovery, and the Contractor shall not be required to be deposed. Management Reviews and Clinical Appeals may not be protected from legal discovery under the Freedom of Information Act (FOIA), but the Contractor shall not be required to be deposed as part of a FOIA document release.

An attorney may supply additional information not requested by the reviewer to the Contractor on business days 11-15 of an active, in-progress case. This shall result in the due date being extended by 5 business days.

The most recently published templates are to be used exclusively.

The only permissible Electronic Health Record is the Joint Longitudinal Viewer (or like system).

Any use of the word “Veteran” must ensure the “V” in Veteran is capitalized.

2.1.1 Audit Reviews

Audit reviews are secondary reviews of a sample of episodes of care that have undergone internal Peer Review for Quality Management.

See Attachment E for an example of an Audit Review template.

The Contractor shall include all required information as seen in Attachment E1.

2.1.2 Facility-Requested Reviews

A Facility-Requested Review (FRR) is an external peer review of an episode of care where the facility desires external expertise (e.g., when there are no qualified local peers or if there is a conflict of interest to complete locally).

See Attachment E for an example of a Facility-Requested Review template (same example as for Audit Review template).

The Contractor shall include all required information as seen in Attachment E2.

2.1.3 Management Reviews

A Management Review is any review that is conducted for purposes other than confidential quality assurance. Management Reviews are not confidential and privileged under 38 U.S.C. 5705 and its implementing regulations and are not considered QM activities. These reviews may require a focused review of a specific clinical discipline and/or a comprehensive review of care. These reviews may or may not name a specific provider.

See Attachment F for an example of a Management Review template.

The Contractor shall include all required information as seen in Attachment F1.

2.1.4 Medical Advisory Opinions

Clinical reviews to provide medical advisory opinions related to the standard of care determinations. A medical advisory opinion is an essential component of the VA Office of General Counsel’s (hereafter referred to as General Counsel) decision to settle or deny a claim. VA regulations, at Title 38 Code of Federal Regulations (CFR) § 14.602(b), provide that Regional Counsel staff are guided by the views of the Under Secretary for Health as to the standard of medical care and treatment, the nature and extent of the injuries, the degree of temporary or permanent disability, the prognosis, the necessity for future treatment or physical rehabilitation, and any other pertinent medical aspects of a claim. Medical advisory opinions are generally protected from discovery in litigation and are exempt from disclosure under the Freedom of Information Act (FOIA) exemption 5 (Title 5 United States Code (U.S.C.) § 552(b)(5)), by the attorney work-product doctrine codified in Rule 26(b)(3), Federal Rules of Civil Procedure. They are not, however, considered confidential and privileged quality assurance records under 38 U.S.C. § 5705. No disclosure should be made of such opinions without the approval of the Regional Counsel or General Counsel. The opinions are qualitatively different from a peer review. Medical issues not identified by General Counsel, but which the reviewer believes are relevant to the episode of care under review should be identified by the reviewer, even if the medical issue was not specifically identified by the General Counsel attorney.

In creating MAOs, the Contractor shall:

1) Use layman terms for medical terms/procedures (i.e., angiogram (x-ray photograph of blood or lymph vessels), arthroplasty (the surgical reconstruction or replacement of a joint)).

2) Provide descriptions of drug categories for medications (i.e., sedative, anti-convulsive, high blood pressure medication) and if dosage is high, normal, or low. For example:

Dilantin (anti-seizure medication), patient was on 10 mg of XXXX (dosage within normal range).

3) Include the range of normal limits for lab results (i.e., blood glucose of 78 (normal range 72-99 mg/dL), hemoglobin 5g/dL level (normal 12-17g/dL)).

4) Provide any other explanations to take technical terms and put them into context for a non-clinical audience.

5) Include internet hyperlinks to any provided references.

See Attachment G for an example of a Medical Advisory Opinions template.

The Contractor shall include all required information as seen in Attachment G1.

2.1.5 Clinical Appeals

Clinical Appeals are reviews that provide recommendations regarding appropriate and/or reasonable and necessary clinical service that was provided and/or denied by VHA. These Clinical Appeals may include caregiver support reviews. These reviews are not considered confidential and privileged quality assurance records under 38 U.S.C. § 5705.

See Attachment H for an example of a Clinical Appeals template.

The Contractor shall include all required information as seen in Attachment H1.

2.1.6 Executive Summaries

Executive summaries may be requested for both protected and non-protected reviews. These summaries shall be for the synthesis of multiple cases.

A reviewer in the specialty in question shall prepare the summary. The Contractor shall provide analysis and summation of trends, commonalities, and/or discordant findings. These summaries shall be at least 2 pages (not including any cover page) and enough to adequately summarize the complexities of the evaluation.

The Contractor shall include all required information as seen in Attachment I.

2.1.7 Reports

A no more than 2-page summary of work performed under the task order at the end of the call order or every 90 business days, whichever is shorter.

The Contractor shall include all required information as seen in Attachment J.

2.1.8 InterRater Reliability (IRR) Studies

Peer reviewers for the Contractor shall undergo a process of inter-rater reliability testing, based on accepted industry standards and a strategy approved by the Contracting Officer’s Representative (COR). This strategy must include what is considered passing, what is failing, remediation and reassessment protocols, and when removal from the panel is warranted.

Findings shall be made available to the COR at the end of the call order.

The Contractor shall include all required information as seen in Attachment K.

2.1.9 Kick-Off Meeting

The Contractor shall not commence performance on the tasks in this Performance Work Statement (PWS) until the Contracting Officer has conducted a kick-off meeting or the Contracting Officer has advised the Contractor that a kick-off meeting is waived. The kick-off meeting shall be held via teleconference and shall last approximately one hour.

2.1.10 Weekly Meetings

The Contractor shall meet with the program office once per week during the ramp-up phase, or as often as needed to accomplish the ramp-up. The COR shall assess the effectiveness of the Contractor and may decrease the frequency of teleconference meetings.

2.1.11 Monthly Meetings

The Contractor shall meet with the program office once per month to discuss reviews and technical aspects as needed (e.g., errors in reports, one-off discussion points, panel depth concerns, individual onboarding updates and concerns).

3.0 Deliverables

Deliverables are due to Office of Medical-Legal Risk Management (MLRM) Monday through Friday, No Later Than (NLT) 5:00 PM, Eastern Time (ET). Any deliverable submitted after 5:00 PM, ET shall be considered as received the following business day.

The Government reserves the right to reassign cases to another Contractor when no action, such as assignment of a reviewer or a note in the system of record, has been taken within four (4) business days of the Contractor receiving the case, or on a case-by-case basis when there is evidence the Contractor does not have the reviewer capacity, specialty, and/or timeliness to meet the due date.

The Government may authorize an extension to a case when an assigned Reviewer cannot successfully login. To be considered, the vendor must provide a summary of the problem and the Enterprise Service Desk ticket number in the request. Extensions shall not be granted if the Reviewer fails to maintain VA systems access.

See the Deliverable Schedule for each type.

Section Deliverable Format Due Date/Time PWS, 2.1 Reviewer Roster

Excel First Business Day of the month

PWS, 2.1.1 Audit Reviews PDF 15 Business days after start date

PWS, 2.1.2 Facility-Requested Reviews PDF 15 Business days after start date

PWS, 2.1.3 Management Reviews PDF 15 Business days after start date

PWS, 2.1.4 Medical Advisory Opinions Word 15 Business days after start date

PWS 2.1.5 Clinical Appeals PDF 15 Business days after start PWS, 2.1.6 Executive Summaries PDF 3 Business Days after the last review’s completion PWS, 2.1.7 Reports PDF End of Call Order or every 90 business days, whichever is shorter

PWS, 2.1.8 InterRater Reliability Plan PDF During Kick Off PWS, 2.1.8 InterRater Reliability Findings Word End of Call Order PWS 2.1.9 Kick-off Meeting teleconference Within 20 business days of award PWS 2.1.10 Weekly Meetings teleconference Once per week

PWS, 2.1.11 Monthly Meetings teleconference As agreed upon by Vendor, Program Manager, and COR

B.4, 2.e Resigned or Removed Reviewers or Staff Notification of resigned reviewers

Email Immediately as needed

B.4, 5.d Information System Hosting, Operation Maintenance, or Use self-assessment

PDF Annually

B.4, 10 Contractor Rules of Behavior signed acknowledgment

PDF At Onboarding

Attachment B VA Form 0752 – NDA PDF At Onboarding Attachment B Reviewer Conflict of Interest

Attestation PDF At Onboarding

4.0 Personnel Requirements/Responsibilities

• On a case-by-case basis, at the discretion of MLRM, the Medical Director and/or the original reviewer/specialist shall be available for a teleconference call with the Veterans Integrated Service Network (VISN), medical center, or MLRM office staff for case discussion.

• On a case-by-case basis, at the discretion of MLRM, the Contractor may need to make the reviewer or Medical Director available to confer with the Department of Veterans Affairs, Office of General Counsel (OGC), or any other legal entity representing the Department of Veterans Affairs, for further clarification of information contained in a Medical Advisory Opinion review. For example, if the reviewer’s opinion is ambiguous or an opinion is provided by the claimant, it may become necessary for the OGC, or any other legal entity representing the Department of Veterans Affairs, to consult with the reviewer or Medical Director.

• These calls shall be billed in 6-minute increments at $100.00 per increment.

• These calls shall be coordinated through MLRM. Points of clarification shall be submitted to the Medical Director in advance of the call to allow sufficient time for preparation and determination if the reviewer must be in attendance.

• Any calls not coordinated through MLRM are not billable.

4.1 Peer Reviewer Qualifications

The Contractor shall verify eligibility of reviewers via current URAC credentialing standards.

Review Curriculum Vitae must be made available to COR upon request. Should the VHA Directive for Peer Review for Quality Management be updated during contract performance, the Contractor shall perform reviews according to the revised standards for levels of care.

Peer Reviewers shall:

• Not be employees or contractors of VHA providing direct care to Veterans;

(limited exceptions may be considered on a case-by-case basis);

• Possess the relevant clinical expertise necessary to make accurate evaluations of the decisions being reviewed;

• Be able to make a fair and credible assessment of the actions taken by a clinician relative to the episode of care under review;

• Possess knowledge of current evidence-based standards of care relevant to the case under review;

• Complete training regarding the peer review process, the responsibilities of the peer reviewer, and the associated legal and ethical requirements. Guidance shall be provided by MLRM.

• Have no direct involvement with the care in question;

• Have no conflicts of interest or other factors that might influence the ability to perform objective, impartial, accurate, and informed review;

• Not be excluded from receiving payment from any Federal healthcare program confirmed through screening through the Health and Human Services Office of Inspector General List of Excluded Individuals and Entities.

• Once fully onboarded: Able to login to the VA network, able to log in to JLV, have a current working PIV card, and able to start a case at the time of assignment.

Only active Contractor personnel may be assigned to or work on VHA cases.

4.1.1 Physician Reviewers

• Shall be board-certified in the specialty they are reviewing according to the American Board of Specialties or equivalent (e.g., American Board of Physician Specialties).

• Shall be in active practice, within the Reviewer’s specialty, at least 20 hours per month. Short-term exceptions to this requirement shall be considered on a case-by-case basis by the COR.

4.1.2 Non-Physician Reviewers

• Must be licensed by a state licensing board if required, or hold a certification according to industry standards; and

• In active practice, within the Reviewer’s specialty, at least 20 hours per month.

Short-term exceptions to this requirement shall be considered on a case-by-case basis by the COR.

4.2 Medical Director Responsibilities

The Medical Director shall:

• Be a physician.

• Represent knowledge and ability to perform oversight in the following disciplines: medicine, surgery, mental health, nursing, and primary care.

• Have access to consult with personnel with a requested medical specialty on an ad hoc basis.

• Review the cases for clinical sufficiency and serve as a resource for clinical guidance.

• Review the credentialing files and provide any other medical guidance for clinical oversight.

• Participate in reconciliation calls and other conference calls at the request of

VHA.

4.3 Contractor/Key Personnel

Conflict of Interest: The Contractor is responsible for identifying and communicating to the CO and/or COR conflicts of interest at the time of proposal and during the entirety of contract performance. Reviewers assigned to this contract must disclose a conflict of interest with any other VA or VHA contract that involves the review of protected patient records or protected review materials such as peer review determinations. If conflict is found, reviewer’s involvement shall be determined by the Government.

All Contractor personnel are subject to immediate removal from performance of this contract if they are involved in a violation of the law, VA security, confidentiality requirements, and/or other disciplinary reasons. The Government reserves the right of refusal to any Contractor personnel on the roster.

Key Personnel: Certain skilled experienced professional and/or technical personnel are essential for meeting the requirements. These individuals are defined as “key personnel”. A list of key personnel shall be included on the monthly roster deliverable.

Personnel assigned by the Contractor to the performance of work on this contract’s requirements shall be acceptable to VHA in terms of personal and professional conduct and technical knowledge.

Employment and staffing difficulties shall not be justification for failure to meet the timeliness metric in the QASP.

Team members that are included in Key Personnel and their qualifications must include:

• Project Manager o Have a minimum of five (5) years of experience managing programs, projects, or contracts of comparable size, scope, and complexity to this procurement o Have experience with government contract oversight o Have a Master’s degree

• Medical Director o Be a Physician o Have a minimum of ten (10) years of experience o Represent knowledge and ability to perform oversight in the following disciplines:

Medicine, Surgery, Mental Health, Primary Care, Emergency Medicine o Have access to consult with personnel with a requested medical specialty on an ad hoc basis o Serve as a resource for clinical guidance o Ensure the clinical sufficiency of cases by having some method of periodic review o Review the credentialing files and provide any other medical guidance for clinical oversight o Participate in calls at the request of VHA

• IT Support and Information Security personnel

• Quality Assurance o Not required to be a licensed clinician

Additional information is referenced in section C.9, Key Personnel.

5.0 General Requirements

5.1 Type of Contract

This Performance Work Statement (PWS) is for a Blanket Purchase Agreement (BPA). BPA Call Orders shall be issued on a firm-fixed-price basis.

5.2 Period of Performance

The period of performance of this BPA is for five years (October 1, 2024, through September 30, 2029). Each BPA Call Order shall specify the period of performance to govern that Call Order.

MLRM Business Hours:

MLRM administrative office is open Monday through Friday, 8:00 am – 5:00 pm ET.

Federal Holidays:

Contractor key personnel is not required to work on Federal holidays or weekends. A list of applicable days can be found on the Office of Personnel Management website at www.opm.gov.

5.3 Place of Performance

http://www.opm.gov/

Tasks under this PWS shall be performed at Contractor facilities.

5.4 Access Requirements

All Contractor personnel that require logical access or physical access must obtain VA-issued PIV Badges to support this requirement. PIV badges shall be obtained in accordance with Homeland Security Personnel Directive (HSPD) requirements.

Contract personnel includes prime, sub, or independent personnel.

NOTE: In order to meet the business needs of the Government, logical access is required for all contract personnel.

This could require at least two trips to a PIV badge office. (listing at: Nationwide PIV Card Office Locations - Office of Operations, Security, and Preparedness (va.gov) https://www.osp.va.gov/Badge_Office_Locations.asp )

This shall mean creating and maintaining a Talent Management System profile for required annual training.

• Course 10203 - Privacy and HIPAA Training – Approximately 1 hour

• Course 10176 - VA Privacy and Information Security Awareness and Rules of Behavior

– Approximately 1 hour.

All Contractor personnel are required to maintain their access to VA systems in order to be considered active. Only active Contractor personnel may be assigned to or work on VA cases.

This shall mean maintaining an active directive account, maintaining login access, and maintaining remote access. This can be accomplished by completing the mandatory training on time and logging into the VA system at least once every 28 days.

PIV card readers shall be required non-Government furnished equipment.

Any and all requests from VHA officials regarding background checks, security, or internet access must be responded to in a timely manner, as prescribed in any notice from any such individual.

Failure to maintain access shall result in the inability to accept work products until that access is restored. Work cannot be assigned to a reviewer that does not have active access.

See Attachment B – Onboarding for additional information.

5.5 Travel

The Government does not anticipate travel. Program-related meetings or conferences shall be conducted by conference call throughout the period of performance. The Government will not pay for travel.

5.6 Performance Requirements

The Contractor’s performance shall be evaluated based on the Quality Assurance Surveillance Plan (Attachment C).

Replacement Cases – If a case is unable to be completed the Government can cancel and replace a case.

https://www.osp.va.gov/Badge_Office_Locations.asp

See Attachment D – Workflow.

5.7 Government Furnished Property/Information

Government-Furnished Property is not applicable to this acquisition.

The Government will provide the Contractor with necessary procedural guides, business rules, reference materials, and program documentation to meet task objectives.

5.8 Protected Health Information (PHI) / Personally Identifiable Information (PII)

The Contractor shall abide by all Government requirements for dissemination of Protected Health Information (PHI) and Personally Identifiable Information (PII). Approved mechanisms are available from the Contracting Officer or COR.

6. Contract Administration

6.1 Ceiling

The estimated ceiling of this BPA across 5 years is $50,000,000.

6.2 Authorized Entities

The VA authorizes the following entities to place call orders against this BPA:

Warranted Contracting Officers of The Strategic Acquisition Center, Frederick.

B.3 IT CONTRACT SECURITY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel will be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor will request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with the latest version of the VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS).

Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately via email when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract will be used only for those purposes and will not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d)(1).

b. VA information should not be co-mingled with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. No co-comingling requires that VA data be stored on disk drives, tape cartridges, and/or storage media that are separate from those used for non-VA data. The contractor must ensure that VA’s information/disk drives/tape cartridges/storage media are returned to the VA or destroyed in accordance with VA’s sanitization requirements, as specified by the COR. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. When requested by the COR, any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and the latest version of VA Handbook 6500.1, Electronic Media Sanitization. If the COR directs the contractor/subcontractor to perform the data destruction, self-certification by the contractor/subcontractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor will not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it will be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140- 2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, will meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor will not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor will immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities…