36C10X19Q0200-0001000.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION

OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADM

INISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and d ate specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 3

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO

MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

NONE

36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703 36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703 To all Offerors/Bidders

36C10X19Q0200 08-14-2019

X X X Tuesday, September 3, 2019 at 13:00 ET X The purpose of this Amendment 00001 is to 1) provide Government Responses to Vendor Questions;

2) provide a revised conformed RFQ Sections B.2 "Price Schedule", B.3 "Performance Work Statement", B.5 "BPA Ordering Procedures", and E.2 "FAR 52.212-2 Evaluation Commercial Items (Oct 2014)”; and extend the due date for quotes to Tuesday, 09/03 at 13:00 ET.

All other terms and conditions remain unchanged.

See continuation pages for Vendor questions and Government responses and confo rmed RFQ sections. Changes are highlighted in yellow.

Corey Mann Contracting Officer

Instructions to Offerors, P 59

Please clarify whether Volume I.a and Volume I.b are to be submitted as two separate files or combined into a single file (i.e., Volume I).

In addition, if Volume I.a and Volume I.b are to be submitted as two separate files, please confirm that Attachment L should not be included in Volume I.b, as it is already included in Volume I.a.

Volume I.a and Volume I.b are to be submitted as separate volumes as instructed in E.1(m).

Attachment L, Technical Evaluation Matrix is intended to be the Volume 1.a submission. Attachment L is not listed as a requirement under Volume I.b.

Peer Review for Quality Management Review

p. 23 Reference: “Medical Records that do not originate at VA facility may need to be evaluate…”

Q. Since non-VA providers are not subject to VA peer review, how does the Government anticipate the evaluation of those non-VA medical records?

The non-VA records will be used as needed to complete the review. If non-VA records were on hand for the VA provider under review and could have influenced their decision making, those records may be necessary to create an accurate and complete review.

Peer Review for Quality Management Review

p. 23 Reference: “The vendor shall verify credential and specialty...before assigning a reviewer”

Q. How does the Government plan for the Contractor to have access to the Electronic Health Record before assigning a case to a reviewer?

Q. How is this reflected in the workflow and timeline?

1. Electronic records will be released to the designated Administrative personnel before they are released to a reviewer. This will allow such designated Administrative personnel to verify credential and specialty.

2. It is reflected in “Vendor Reviews Case” in the workflow. The start date is determined by the government.

Q. Are deliverables due on Government business days, Monday through Friday?

Yes, deliverables are due on Government business days.

Q. Who does the Government define as contractor personnel that require logical access…”?

1. Personnel that require logical access are defined as those personnel who require remote access to VA data systems as described in PWS B.4 #20 on p. 41.

Contract Employees Who Require Physical or Logical Access

p. 41 – 42 and Attachment B Reference: “…requiring PIV access on board…”

Q. Approximately how long does it take for Contractor staff to go through on-boarding process and get PIV access?

Q. How does the Government propose Offerors should reflect costs associated with onboarding, including, but not limited to, the time associated with obtaining a PIV card, be reflected in Pricing since there is no specific Contract Line Item?

1. The PIV access/onboarding process is dependent on a multitude of factors, including paper vs. electronic fingerprints, Background Investigations, previous (if any) government clearances held, and responsiveness of contractor.

2. The Offeror should build the costs associated with onboarding into their deliverable pricing.

Contract Employees Who Do Not Require Physical or Logical Access

p. 42 and Attachment B Reference: “estimation of process…contractors not requiring PIV access…”

Q. Approximately how long does it take for Reviewers to go through on-boarding?

The PIV access/onboarding process is dependent on a multitude of factors, including paper vs. electronic fingerprints, Background Investigations, previous (if any) government clearances held, and responsiveness of contractor.

BPA Ordering Procedures p.43- 44 Reference: “A. 2. If a BPA Call is issued via procedures in D.1.a. or D.1.b. above…” and “D.1.c…”

Q. D.1.a, D1b. and D.1.c. does not appear to be in the Solicitation The references should read “A.1.a and A.1.B” and “A.1.c.” The PWS Section is updated to reflect this change.

Attachment D / Workflow References:

• “Due dates – Audits – 15 Business days;

• Facility Requested Reviews – 10 Business Days

• Management Reviews – 10 Business Days”

Q. 3.0, Deliverable grid, and Attachment D, Workflow, do not indicate when the government start date begins and if the start date is adjusted until supplemental documents are received and/or adjusted if demographic data from VA needs to be corrected/revised. Please clarify.

The Government sets the start date. The start date will never be set without receipt of supplemental documents and therefore will not need to be adjusted.

Vendors are not provided with demographic information; only patient name, provider name, a date range, and a handful of questions to answer.

Attachment D / Workflow Reference: “Vendor Reviews Case” identified as Vendor task – “The vendor shall verify credential and specialty...before assigning a reviewer” is not included in workflow.

Q. How does the Government anticipate this step being incorporated into the workflow?

Electronic records will be released to the designated Administrative personnel before they are released to a reviewer. This will allow such designated Administrative personnel to verify credential and specialty.

This is reflected in “Vendor Reviews Case” in the workflow.

• 4.2, Peer Review Qualifications – Pg. 26;

• 8, Training – Pg. 36;

• 12, Cyber and Information Security Requirements for VA IT Service (d) – Pg. 38;

• 20, Contractor Employees Who Require Physical or Logical Access (f) – Pg. 42; and

• 21 Contractor Employees Who Do Not Require Physical or Logical Access (e) – Pg. 42

The sections/titles identified in the columns to the left all pertain to training associated with this solicitation.

Q. Because of the extent of training required, how does the Government propose Offerors should reflect costs associated with training?

The Offeror should build the costs associated with training into their deliverable pricing.

Instructions to Offerors, Vol. II Past Performance - page 61 of 73

Reference: The RFQ states in part: "The offeror shall complete Attachment M: Past Performance References in its entirety, listing a total of three contracts/orders completed during the past three years or currently being performed that are similar to the solicitation size, scope and/or complexity.

Q. For purposes of the Past Performance evaluation, how is VHA defining "solicitation size, scope and complexity" of the contracts/orders identified by an offeror?

The VA defines size, scope, and complexity as follows:

Size: similarity of reference in dollar value to the current requirement.

Scope: similarity of the type of work performed under the reference to the type of work outlined in the PWS.

Complexity: similarity of the complexity of the work performed under the reference to the work outlined in the current requirement.

Instructions to Offerors, Vol. II Past Performance - page 61 of 73

Reference: The RFQ defines a major subcontract as "20% of the total contract effort."

Q. How will VHA evaluate whether a subcontractor is to perform 20% of the total contract effort? What metrics will VHA use for that evaluation?

Proposed subcontractors should be listed in Volume III – Socioeconomic Considerations along with the percentage of total contract effort to be performed by the subcontractor as measure in total contract value.

FAR 52.212-2 Evaluation - Commercial Items (Oct 2014), page 64 of 73 How many BPAs does the Government anticipate will be awarded pursuant to the RFQ? (Section E.2 states in part: "The Government intends to award a multiple-award Blanket Purchase Agreement (BPA) . . . .").

As stated in Section E.2 of the RFQ, The Government reserves the right to establish as many or as few BPA’s as determined appropriate based on the results of this competition.

Factors to be Evaluated, Pg. 65 Will Price be evaluated on the total contractor proposed cost for all quantity of services priced out for all five years of the contract?

The price will be evaluated based on the complete price scheduled found in PWS Section B.2. Estimated quantities are provided for all 5 years.

Q. Should this read 5-years?

Q. The Offeror will not know the value until the Blanket Purchase Agreement (BPA) and Call Orders are awarded. How should we respond?

Q. The section also asks for the participation as a Prime Contractor. Again, the contractor will not know the value until the Blanket Purchase Agreement (BPA) and Call Orders are awarded. How should we respond to these issues?

1. Yes, this should be five years.

2. Vendors should use the estimated quantities provided in the Price Schedule to determine the value to be subcontracted.

3. Vendors should use the estimated quantities provided in the Price Schedule to determine the value to be subcontracted.

The estimated quantities shown in B.2, Price Schedule, are annual estimates only. The quantities in each Call will vary dependent on the requirement for the individual Call.

Attachments F “Review Template MAN”, A “Specialties”, and B “Onboarding Documents” are attachments referenced in the PWS tasks and included for clarity of the requirements.

Could the government please describe the criteria to be applied to ensure “an equitable manner”?

How will the government make the determination if multiple BPA holders can provide the “required specialist(s)”?

The Government intends to ensure equitable distribution via the total dollars obligated during each period to each contractor. However, other methods may be utilized based on information gathered during performance.

For Audits: There is an algorithm in the assignment code that is load-sensitive, allowing for equity in assignments. Which ever vendor has the lightest load will be next in queue.

For Non-Audits: It will depend on the requirements of the project. For example: If a large project demands the same reviewer for 30 cases, then the remaining vendors would be above it in queue for next projects.

The RFQ states that “certified cost or pricing data are not required for individual Calls”.

The RFQ also states that each CQR response should include “quote”.

Could the government please clarify what will comprise a “quote”?

The references should read “A.1.a and A.1.B” and “A.1.c.” The PWS Section is updated to reflect this change.

Should the Government issue a call requiring a quote, the Call Quote Request will include instructions for the creation of the call level quote. In accordance with A.1.c, these quotes, in general, will be evaluated by analysis of price, availability of specialist(s) require for reports under the Call, Key Personnel, and the current workload/capacity of the BPA holders. Other evaluation factors may be used if deemed appropriate by the Contracting Officer. Therefore vendors may expect the quote the be comprised of such information.

Could the government please define how credit will be applied to this factor, specifically, what is meant by “receive some evaluation credit”?

The Government will not provide the definitions of the evaluation ratings as part of the solicitation.

Question: With a solicitation issue date of 8/14/2019 and a due date of 8/27/2019, ten (10) working days does not allow bidders much time to prepare and submit a comprehensive, well thought out bid, especially if bidders need to reach out to subcontractors/partners for the solution. Would the Department consider an extension on the due date (e.g., September 6th?

The due date for quotes is hereby extended until Wednesday, September 3, 2019 at 01:00 PM/ET

Instructions to Offerors, P 59-60

RFP Text: Quotations submitted in response to this solicitation shall contain the following separate volumes.

Question: Does the Department want Volume I.a and I.b submitted as two separate volumes or should the bidder combine volumes I.a and I.b into one volume and submit the combined information as Volume I?

Volume I.a and Volume I.b are to be submitted as separate volumes as instructed in E.1(m).

B.2 PRICE SCHEDULE

ITEM INFORMATION

Year One October 1, 2019 – September 30, 2020

Peer Review for Quality Management - Year 1 Contract Period: Base POP Begin: 10-01-2019 POP End: 09-30-2020

0001A

Audit Review (Tier 1)

0001B

Audit Review (Tier 2)

0001C

Audit Review (Tier 3)

0001D

Facility-Requested Review (Tier 1)

0001E

Facility-Requested Review (Tier 2)

0001F

Facility-Requested Review (Tier 3)

Management Reviews - Year 1

0002A

Routine Management Reviews (Tier 1)

0002B

Routine Management Reviews (Tier 2)

0002C

Routine Management Reviews (Tier 3)

0002D

Medical Advisory Opinion (Tier 1)

0002E

Medical Advisory Opinion (Tier 2)

0002F

Medical Advisory Opinion (Tier 3)

0002G

Clinical Appeals (Tier 1)

0002H

Clinical Appeals (Tier 2)

0002I

Clinical Appeals (Tier 3)

Executive Summary Reports- Year 1

0003A

Executive Summary Reports (Step 1)

0003B

Executive Summary Reports (Step 2)

0003C

Executive Summary Reports (Step 3)

End of Call/90 day Reports- Year 1

Inter-Rater Reliability (IRR) Studies- Year 1

Year Two October 1, 2020 – September 30, 2021

Peer Review for Quality Management - Year 2 Contract Period: Year 2 POP Begin: 10-01-2020 POP End: 09-30-2021

1001A

Audit Review (Tier 1)

1001B

Audit Review (Tier 2)

1001C

Audit Review (Tier 3)

1001D

Facility-Requested Review (Tier 1)

1001E

Facility-Requested Review (Tier 2)

1001F

Facility-Requested Review (Tier 3)

Management Reviews - Year 2

1002A

Routine Management Reviews (Tier 1)

1002B

Routine Management Reviews (Tier 2)

1002C

Routine Management Reviews (Tier 3)

1002D

Medical Advisory Opinion (Tier 1)

1002E

Medical Advisory Opinion (Tier 2)

1002F

Medical Advisory Opinion (Tier 3)

1002G

Clinical Appeals (Tier 1)

1002H

Clinical Appeals (Tier 2)

1002I

Clinical Appeals (Tier 3)

Executive Summary Reports- Year 2

1003A

Executive Summary Reports (Step 1)

1003B

Executive Summary Reports (Step 2)

1003C

Executive Summary Reports (Step 3)

End of Call/90 day Reports- Year 2

Inter-Rater Reliability (IRR) Studies- Year 2

Year Three October 1, 2021 – September 30, 2022

Peer Review for Quality Management - Year 3 Contract Period: Year 3 POP Begin: 10-01-2021 POP End: 09-30-2022

2001A

Audit Review (Tier 1)

2001B

Audit Review (Tier 2)

2001C

Audit Review (Tier 3)

2001D

Facility-Requested Review (Tier 1)

2001E

Facility-Requested Review (Tier 2)

2001F

Facility-Requested Review (Tier 3)

Management Reviews - Year 1

2002A

Routine Management Reviews (Tier 1)

2002B

Routine Management Reviews (Tier 2)

2002C

Routine Management Reviews (Tier 3)

2002D

Medical Advisory Opinion (Tier 1)

2002E

Medical Advisory Opinion (Tier 2)

2002F

Medical Advisory Opinion (Tier 3)

2002G

Clinical Appeals (Tier 1)

2002H

Clinical Appeals (Tier 2)

2002I

Clinical Appeals (Tier 3)

Executive Summary Reports- Year 3

2003A

Executive Summary Reports (Step 1)

2003B

Executive Summary Reports (Step 2)

2003C

Executive Summary Reports (Step 3)

End of Call/90 day Reports- Year 3

Inter-Rater Reliability (IRR) Studies- Year 3

Year Four October 1, 2022 – September 30, 2023

Peer Review for Quality Management - Year 4 Contract Period: Year 4 POP Begin: 10-01-2022 POP End: 09-30-2023

3001A

Audit Review (Tier 1)

3001B

Audit Review (Tier 2)

3001C

Audit Review (Tier 3)

3001D

Facility-Requested Review (Tier 1)

3001E

Facility-Requested Review (Tier 2)

3001F

Facility-Requested Review (Tier 3)

Management Reviews - Year 4

3002A

Routine Management Reviews (Tier 1)

3002B

Routine Management Reviews (Tier 2)

3002C

Routine Management Reviews (Tier 3)

3002D

Medical Advisory Opinion (Tier 1)

3002E

Medical Advisory Opinion (Tier 2)

3002F

Medical Advisory Opinion (Tier 3)

3002G

Clinical Appeals (Tier 1)

3002H

Clinical Appeals (Tier 2)

3002I

Clinical Appeals (Tier 3)

Executive Summary Reports- Year 4

3003A

Executive Summary Reports (Step 1)

3003B

Executive Summary Reports (Step 2)

3003C

Executive Summary Reports (Step 3)

End of Call/90 day Reports- Year 4

Inter-Rater Reliability (IRR) Studies- Year 4

Year Five October 1, 2023 – September 30, 2024

Peer Review for Quality Management - Year 5 Contract Period: Year 5 POP Begin: 10-01-2023 POP End: 09-30-2024

4001A

Audit Review (Tier 1)

4001B

Audit Review (Tier 2)

4001C

Audit Review (Tier 3)

4001D

Facility-Requested Review (Tier 1)

4001E

Facility-Requested Review (Tier 2)

4001F

Facility-Requested Review (Tier 3)

Management Reviews - Year 5

4002A

Routine Management Reviews (Tier 1)

4002B

Routine Management Reviews (Tier 2)

4002C

Routine Management Reviews (Tier 3)

4002D

Medical Advisory Opinion (Tier 1)

4002E

Medical Advisory Opinion (Tier 2)

4002F

Medical Advisory Opinion (Tier 3)

4002G

Clinical Appeals (Tier 1)

4002H

Clinical Appeals (Tier 2)

4002I

Clinical Appeals (Tier 3)

Executive Summary Reports- Year 5

4003A

Executive Summary Reports (Step 1)

4003B

Executive Summary Reports (Step 2)

4003C

Executive Summary Reports (Step 3)

End of Call/90 day Reports- Year 5

Inter-Rater Reliability (IRR) Studies- Year 5

B.3 PERFORMANCE WORK STATEMENT

Clinical Peer Review Blanket Purchase Agreement (BPA)

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 provide the highest quality care possible for Veterans. Past audits of peer review conducted internally by VHA staff identified opportunities for improving the peer review process within VHA. To facilitate implementation of the requirements of VHA Directive 1190 and to develop a process for improving the rigor and objectivity of peer review, VHA seeks a national Contractor with proven expertise in conducting 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 review of medical records and report templates.

Under this Blanket Purchase Agreement (BPA), the contractor shall conduct the following:

· Peer Review for Quality Management

· Audits

· Facility Request Reviews

· Management Review

· Management Review

· Medical Advisory Opinion

· Clinical Appeals

· 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 6,000 reviews per year, divided between Peer Reviews and Management Reviews, according to VA's needs. The estimated target number of annual reviews per category is listed below:

· Peer Reviews

· Approximately 4250 Audit Reviews

· Approximately 1000 Facility-Requested Reviews

· Management Reviews

· Approximately 700 Routine Management Reviews

· Approximately 45 Medical Advisory Opinions

· Approximately 5 Clinical Appeals

1.4 Applicable Documents

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with 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 17l.511.

· 38 U.S.C. §7332, “HIV Infection and Sickle Cell Anemia Medical Records”.

· 38 U.S.C. §5701, “VA Claims Confidentiality Statute”.

· 38 U.S.C. §5705, “Confidentiality of Healthcare Quality Assurance Review Records”.

· Federal Information Security Management Act (FISMA).

· Privacy Act and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

· Public Law 109-461, 5725, Confidentiality of Drug Abuse, Alcoholism and Alcohol Abuse.

· Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements For Cryptographic Modules”

· FIPS Pub 201, “Personal Identity Verification of Federal Employees and Contractors,” March 2006

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

· Software Engineering Institute, Software Acquisition Capability Maturity Modeling (SA CMM) Level 2 procedures and processes

· 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 Suitability and Security Program,” June 04, 2010

· VA Directive 6102, “Internet/Intranet Services,” July 15, 2008

· 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

· OMB Circular A-130, “Management of Federal Information Resources,” November 28, 2000

· 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE”

· 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, 1998

· 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 https://www.voa.va.gov/)

· 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, February 26, 2009

· 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 2007-028, VHA Medical Advisory Opinion Requests by Regional Counsel, September 17, 2007

· Federal Rules of Civil Procedure, Rule 26(b)(4)

· VHA Directive 1190, Peer Review for Quality Management, November 21, 2018

· VHA Directive 1041, Appeal of VHA Clinical Decisions, October 24, 2016

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 conducted in accordance with all applicable laws, regulations, current VHA policies, and VHA Directive 1190. 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 initiation of any administrative actions (e.g., modification of clinical privileges).

· Identification of system and process issues that may need Peer Reviews shall be conducted 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 the VA. The review panel shall include non-physician Providers, such as Physician Assistants (PA), Advanced Practice Nurses (APRN), and Certified Registered Nurse Anesthetists (CRNA), Psychologists, Pharmacists, Registered Nurses, Licensed Vocational Nurses, Social Workers, and other providers.

Depth at key specialties such as Cardiothoracic Surgery, Interventional Cardiology, Vascular Surgery, Neurosurgery 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 categories.

Panel Requirements 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.

Contractor will provide a roster of all reviewers (listing 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 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.

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 additional medical director oversight in a written review. This level of oversight shall be considered part of the quality assurance process.

For every case, the vendor will be given access to the patient record in Community Viewer (or like system). The vendor shall verify credential and specialty of the provider under review for each case before assigning a reviewer. Any incompatible peer matches will be reported as part of the quality assurance surveillance plan.

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 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 Facility-Requested Review template.

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

2.1.3 Management Review

Management Reviews are not confidential and privileged under 38 U.S.C. §5705 and it’s implementing regulations and are not considered Quality Management activities These reviews may require a comprehensive review of care and/or a focused review of a specific clinical discipline.

See Attachment F for Management Review template.

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

Outside of routine management reviews, there are two specialized groups of management reviews:

2.1.4 Medical Advisory Opinion

Clinical reviews to provide medical advisory opinions related to standard of care determinations. A medical advisory opinion is an essential component of the VA General Counsel’s 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.

See Attachment G for Medical Advisory Opinions template.

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

2.1.5 Clinical Appeals

Clinical reviews provide recommendations regarding appropriate and/or reasonable and necessary clinical service 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 F for Clinical Appeals template.

The Contractor shall include all required information as seen in Attachment F2.

2.1.6 Executive Summaries

Executive summaries may be requested for both protected and non-protected reviews. These summaries will be for 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 that call or every 90 days, whichever is shorter.

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

2.1.8 Inter-Rater 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.

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 will be held via teleconference and will 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 will 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 one per month to discuss Users and technical aspects as needed (e.g., errors in reports, one-off discussion points, panel depth concerns, individual on-boarding updates and concerns).

3.0 Deliverables

Deliverables are due to VHA Monday through Friday, No Later Than (NLT) 3:00PM, Eastern Time (ET). Any deliverable submitted after 3:00PM, ET shall be considered as received the following business day. See Deliverable Schedule for each type.

All reviews shall be submitted in PDF format.

self-assessment

4.0 Personnel Requirements/Responsibilities

· The Medical Director and the original reviewer/specialist shall be available on a case-by-case basis for a teleconference call with Veterans Integrated Service Network (VISN), medical center, and RM office staff for case discussion. The original reviewer/specialist shall be present on the teleconference call.

· The contractor may need to make the reviewer available to confer with VA District Counsel for further clarification of information contained in a Medical Advisory Opinion review. For example, if there is ambiguity in the reviewer’s opinion or an opinion is provided by the claimant, it may become necessary for the VA Regional Counsel to consult with the reviewer.

· These calls shall be billed in 15-minute increments.

4.1 Peer Reviewer Qualifications

The contractor shall verify eligibility of reviewers via current URAC credentialing standards. Reviewer 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 conduct reviews according to the revised standards for levels of care.

Peer Reviewers shall:

· Not be employees or contractors of VA 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 about 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, responsibilities of the peer reviewer, and the associated legal and ethical requirements. Guidance will be provided by VA Central Office Risk Management (VACO RM).

· Have no direct involvement with the care in question;

· Have no conflicts of interest or other factors that might influence the ability to conduct 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.

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 at least 20-hours per month. Short-term exceptions to this requirement will 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; and

· In active practice at least 20 hours per month. Short-term exceptions to this requirement will 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, Primary Care/ED

· 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 VA.

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 five years. Each BPA Call Order shall specify the period of performance to govern that Task Order.

5.3 Place of Performance

Tasks under this PWS shall be performed at contractor facilities.

The 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.

5.4 Travel

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

5.5 Performance Requirements

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

Replacement Cases – If a case is unable to be complete the Government can cancel and replace a 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. See Attachment D – workflow.

5.6 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.

5.7 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 over 5 years is $20,000,000

B.5 BPA ORDERING PROCEDURES

1. The Government anticipates issuing BPA Calls on an annual basis; however, the Government may issue Calls at any time. Individual Calls cannot exceed $7,000,000. Resulting Calls will be Firm-Fixed Price. Each Call will specify details as they relate to deliverables, performance, and other technical items.

2. Streamlined evaluation process is permitted under the Federal Acquisition Streamlining Act of 1994. Therefore, when placing BPA Calls, the CO is not required to prepare formal evaluation plans, score Quotes, post notice on the Federal Business Opportunities (FedBizOpps) website or hold discussions or negotiations with each…