36C24726Q0111-Sources Sought.docx

SUBJECT*

Emergent Reference Lab Testing

GENERAL INFORMATION

SET-ASIDE

Central Alabama Veterans Health Care West Campus 215 Perry Hill Road Montgomery AL 36109-3798

POINT OF CONTACT*

Contract Specialist Monica Reed Monica.Reed@va.gov Email Only

PLACE OF PERFORMANCE

Ralph Johnson VA Medical Center

109 Bee Street

Charleston SC

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI

1. Title: EMERGENT REFERENCE LAB TESTING

2. Purpose: The purpose of this RFI is to identify potential sources which will aid in defining the procurement strategy (e.g., set-aside, sole source, unrestricted) for a solicitation the VA intends on issuing shortly for the following:

EMERGENT REFERENCE LAB TESTING

SEE ATTACHED STATEMENT OF WORK-must meet

SEE BOTTOM OF DOCUMENT & ANSWER QUESTIONAIRE

The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code 621511 ___________ is ___$41.5 MIL (employees or dollars).

3. Responses Requested: The following questions must be answered in response to this RFI.

Answers that are not provided shall be considered non-responsive to the RFI:

a. Where are the requested items/equipment manufactured?

Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

b. Are the requested items/equipment manufactured by a Small or Large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)?

Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts which may be required in performance of this requirement?

The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice.

d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following:

Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________

Company's business size: ________________________________________________ Data Universal Numbering System (DUNS) #: _______________________________

e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite __________________ NAICS code?

· Please provide proof of qualifications.

f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)?

If so, please identify the contract number for the Government to review as part of this Market Research.

4. Opportunity/Market Pricing: The Ralph H. Johnson VA Medical Center located at 109 Bee Street Charleston; SC 29401 is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the Charleston VAMC (RHJVAMC) in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation.

5. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 12:00 pm (ET), Wednesday, November 19, 2025 via email to Monica.Reed@va.gov

RFI responses are due by 04:00pm (CST), Wednesday, November 19, 2025; size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to monica.reed@va.gov The subject line shall read: Charleston VAMC (RHJVAMC). NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f).

Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI. Information provided will be used solely by Charleston VAMC as “Market Research” and will not be released outside of the Charleston VAMC (RHJVAMC) Contracting Team.

7. Contact Information:

Monica Reed monica.reed@va.gov

Your response to this notice is greatly appreciated!

Sources Sought Notice Sources Sought Notice

Sources Sought Notice

This block will not print. Cleaned up by Gayle 3/7/96. EMERGENT REFERENCE LABORATORY TESTING

STATEMENT OF WORK

SCOPE OF WORK.

The contractor shall provide laboratory testing service for patient specimens that are urgent/emergent, and/or have limited viability, and not performed at the Ralph H. Johnson VA Medical, Charleston, SC. Testing includes, but is not limited to, Mycobacteria Stains, Microbiology Specimens, Immunoperoxidase Stains, Therapeutic Drugs, Bone Marrow Workup, and Clotting Factor assays. Turnaround time for STAT/emergent testing is 24 hours, or less, as indicated for patient care.

PERFORMANCE MEASURES

Performance measures, indicated in the Quality Assurance Surveillance Plan (QASP), are based on acceptable turnaround times, test completion, and error rates (Corrected Reports).

QUALIFICATIONS

· Current/Valid CMS CLIA Certificate for High Complexity Testing.

and

· Current/Valid Laboratory Accrediting Agency Certificate, i.e., College of American Pathologists (CAP), or The Joint Commission (TJC)

HOURS OF PERFORMANCE

The contracting laboratory must be available to accept specimens seven (7) days a week and must have testing services available 24 hours a day, for those tests that can be ordered with STAT urgency.

CONTRACTOR FURNISHED PROPERTY AND PERSONNEL SERVICES

· Specimen Courier

· Special Collection Kits/Containers/Media/Biohazard Bags for tests performed by the contractor.

SPECIFIC TASKS

· The contractor will perform accurate laboratory testing.

· The contractor will provide test results within acceptable time frames for the specified testing. Finalized laboratory results/reports are available by providing access to electronic result data and faxed to the P&LMS administrative office.

· The contractor’s specimen courier shall pick up laboratory specimens Monday – Friday, twice a day, at approximately 09:00a.m. and again at approximately 16:00p.m.

· The contractor shall schedule courier service, upon request, for any off route/STAT, night, and weekend specimen pickups.

MONITORING

The Contracting Officer’s Representative (COR), and the VAMC Laboratory Manager will monitor contractor performance as indicated in the Quality Assurance Surveillance Plan (QASP).

PAYMENT

Payment will be made monthly in arrears for services rendered after receipt of a proper invoice. The VA Medical Center will establish and maintain a contract file. The Contractor must actually perform the required services in accordance with contract specifications in order to receive compensation.

· Invoices must contain the following information:

DATA SECURITY

Information, including, but not limited to, veteran individually-identifiable information (iii) and personal healthcare information (PHI), gathered or created by the Contractor in the performance of this contract is the exclusive property of VA and must be received, gathered, stored, backed up, maintained, used, disclosed and disposed of in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations and policies, including VA Directive and Handbook number 6500.

· The Contractor shall provide access to VA information to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable.

· The Contractor shall immediately (on the date of discovery of the incident) report any incident of theft, loss or comprise of VA sensitive information to the Contracting Officer, the Contracting Officer’s Technical Representative and any other VA Official designated by the Contracting Officer. This report shall be in writing and contain the fullest explanation possible and all the details of the incident available to the contractor. VA must receive notice fro the contractor on the date contractor discovers incident.

HIPPA Compliance. The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI)

CONTRACT ADMINISTRATION DATA

The contracting officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

DESIGNATION OF CONTRACTING OFFICER’S REPRESENTATIVE (COR)

A VA Medical center representative of the Contracting Officer (COR) shall be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this task order. The foregoing is not to be construed as authorization to interpret or furnish advice or information to the Contractor relative to the financial or legal aspects of the task order. Enforcement of these segments is vested and the sole responsibility of the Contracting Officer.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. RHJ VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with RHJ VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public RHJ VAMC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The RHJ VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall 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 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 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.

VA INFORMATION CUSTODIAL LANGUAGE

f. 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 shall be used only for those purposes and shall 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).

g. VA information should not be co-mingled, if possible, 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. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. 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.

h. 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. 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 VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor 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.

i. 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.

j. The contractor/subcontractor shall 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.

VA HANDBOOK 6500.6 APPENDIX C

MARCH 12, 2010

Page 1 of C-10

k. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall 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.

l. 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.

m. 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.

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

o. 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.

p. Notwithstanding the provision above, the contractor/subcontractor shall 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 shall immediately refer such court orders or other requests to the VA contracting officer for response.

q. 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 COTR.

SECURITY INCIDENT INVESTIGATION

r. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

s. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

t. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

u. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

v. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

w. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

x. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

y. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day’s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

LABORATORY TESTING SERVICES

TABLE OF CONTENTS

QUALITY ASSURANCE SURVEILLANCE PLAN

(QASP)

INTRODUCTION

This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the statement of work (SOW) entitled MUHA Laboratory Testing Services. This plan sets forth the procedures and guidelines Pathology and Laboratory Services will use in ensuring the required performance standards or services levels are achieved by the contractor.

Purpose The purpose of the QASP is to describe the systematic methods used to monitor performance and to identify the required documentation and the resources to be employed. The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the SOW and the contractor’s quality control plan (QCP), and to ensure that the government pays only for the level of services received.

This QASP defines the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

Performance Management Approach The SOW structures the acquisition around “what” service or quality level is required, as opposed to “how” the contractor should perform the work (i.e., results, not compliance). This QASP will define the performance management approach taken by Pathology and Laboratory Services to monitor and manage the contractor’s performance to ensure the expected outcomes or performance objectives communicated in the SOW are achieved. Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes are being achieved by the contractor.

Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met.

Performance Management Strategy The contractor is responsible for the quality of all work performed. The contractor measures that quality through the contractor’s own quality control (QC) program. QC is work output, not workers, and therefore includes all work performed under this contract regardless of whether the work is performed by contractor employees or by subcontractors. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the SOW. The contractor will develop and implement a performance management system with processes to assess and report its performance to the designated government representative. The contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the SOW. This QASP enables the government to take advantage of the contractor’s QC program.

1.3.2 The government representative(s) will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

ROLES AND RESPONSIBILITIES

The Contracting Officer The contracting officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the Pathology and Laboratory Services’ contracting officer's representative (COR) and the contractor. The CO will designate one full-time COR as the government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the contractor’s performance, and must be identified and designated by the CO.

The Contracting Officer’s Technical Representative The contracting officer’s representative (COR) is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards and/or quality levels are included in the SOW and in Attachment 1, “Performance Requirements Summary.” If the contractor meets the required service or performance level, it will be paid the amount agreed on in the contract. Failure to meet the required service will result in nonpayment of the amount agreed on in the contract.

METHODOLOGIES TO MONITOR PERFORMANCE

Surveillance Techniques In an effort to minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary methods of surveillance are:

· Random monitoring, which shall be performed by the COR.

· 100% Invoice Inspection – Each quarter, the COR, shall review the generated invoices and enter summary results into the QASP Spreadsheet.

Customer Feedback The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.

The contractor shall address customer complaints and investigate issues and/or problems, but the customer always has the option to communicate complaints to the COR as opposed to the contractor.

Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, and must be forwarded to the COR. The COR will accept those customer complaints and initiate an investigation.

Acceptable Quality Levels The acceptable quality levels (AQLs) included in Attachment 1, Performance Requirements Summary Table, for contractor performance are structured to allow the contractor to manage how the work is performed.

Quality Assurance Documentation The Performance Management Feedback Loop The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the SOW and are assessed using the performance monitoring techniques shown in Attachment 1.

Monitoring Forms The government’s QA surveillance, accomplished by the COR, will be reported using the monitoring form in Attachment 2. The form, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure that the required results are achieved.

The COR will retain a copy of all completed QA surveillance forms.

ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

Determining Performance Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the contractor has not met the minimum requirements, it may be asked to develop a corrective action plan to show how and by what date it intends to bring performance up to the required levels.

Reporting At the end of each Quarter, the COR will prepare a written report summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report and the completed quality assurance monitoring form (Attachment 2) will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives.

Reviews and Resolution The COR may require the contractor’s project manager, or a designated alternate, to meet with the COR and other government personnel as deemed necessary to discuss performance evaluations. The agenda of the reviews may include:

· Monthly performance assessment data and trend analysis

· Issues and concerns of both parties

· Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis

· Recommendations for improved efficiency and/or effectiveness

The COR must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

The COR and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the PCO/ACO.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

Required Services (Tasks) Performance Standards Acceptable Quality Levels Methods of Surveillance

Reference Laboratory Testing Services – Completion Rate.

100% Complete

100% Complete

Random Monitoring

Reference Laboratory Testing Services – Error Rate(Corrected Reports)

No Corrected Reports/Results

No Corrected Reports/Results

All reported instances

ATTACHMENT 2: QUALITY ASSURANCE

MONITORING FORM

SERVICE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (Check):

Random Sampling 100% Inspection Periodic Inspection Customer Complaint LEVEL OF SURVEILLANCE (Check):

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Narrative of Performance During Survey Period:

PREPARED BY: ___________________________________ DATE: _________________