36C10G19R0048-000.docx

36C10G19R0048

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

Matthew Cron | Matthew.cron@va.gov

(540) 735-3800 08-29-2019

2:00 PM EST

U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave Suite 400 Fredericksburg VA 22408

X

511210 38.5M

N/A

U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave

Fredericksburg VA 22408

U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave

Fredericksburg VA 22408

Financial Services Center

PO BOX 149971

Austin TX 78714-8917

See CONTINUATION Page Title: Laboratory Accreditation Services

This is a Request for Proposal (RFP) to establish a Firm-Fixed Price contract for the procurement of Laboratory Accreditation services.

The period of performance will be for one (1) base year period with three (3), one (1) year option periods, for a total of four (4) years.

Prospective offerors may submit questions requesting clarifications of the solicitation requirement to the Contracting Officer and Contract Specialist via e-mail at Matthew.Cron@va.gov and Gwennifer.Epps@va.gov, no later than Friday, August 16, 2019 1:00 PM, EST. Proposals are due on or before Thursday, August 29, 2019 2:00 PM, EST.

See CONTINUATION Page

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C10G

Strategic Acquisition Center 10300 Spotsylvania Ave Suite 400 Fredericksburg VA 22408

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-8917

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

Page 1 of Page 1 of B2. Price/Cost Schedule

CLIN/

SCLIN

0003AA

High Complexity

0003AB

Moderate Complexity

Each

Initial Inspection, Quality Assessment, and Laboratory Accreditation Services for High and Moderate Complexity IAW para. 4.1.4 in the PWS.

TOTAL Base Period - Period of Performance, to be determined (TBD)

On Cycle Inspection IAW para. 4.1.2 in the PWS for High and Moderate Complexity laboratories IAW Technical Exhibit A.

0102AA

High Complexity

Each

1002AB

Moderate Complexity

Each

Out of Cycle Inspection or Initial Inspection, Quality Assessment, and Laboratory Accreditation Services IAW para. 4.1.3 in the PWS for High and Moderate Complexity laboratories IAW Technical Exhibit A.

TOTAL Option Year One - Period of Performance TBD

On Cycle Inspection IAW para. 4.1.2 in the PWS for High and Moderate Complexity laboratories IAW Technical Exhibit A.

Initial Inspection, Quality Assessment, and Laboratory Accreditation Services for High and Moderate Complexity IAW para. 4.1.4 in the PWS.

Each

TOTAL Option Year Two - Period of Performance TBD

Initial Inspection, Quality Assessment, and Laboratory Accreditation Services for High and Moderate Complexity IAW para. 4.1.4 in the PWS.

TOTAL Option Year Three - Period of Performance TBD

GRAND TOTAL FOR BASE AND ALL OPTION PERIODS

B.3 PERFORMANCE WORK STATEMENT (PWS)

Part 1. Scope of Work: This is a requirement for non-personal services to provide Accreditation of Laboratory Services. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Accreditation of Laboratory Services as defined in this Performance Work Statement. The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as an accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by Joint Commission (JC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative.

1.2 Background: Department of Veterans Affairs (VA) Laboratories have been accredited for over 40 years. The laboratory accreditation process is a complex system of related and dependent activities. It includes pre-inspection/review activities (e.g., education on accreditation process, application); inspection/review activities (e.g., on-site inspection/reviews, inspection/review notification to Laboratory Director and VA National Pathology & Laboratory Medicine Service (PLMS) Representative, inspection/review validation/notification process); post inspection/review and monitoring activities (e.g., ongoing communication; inspection/review report(s) in an exportable format (access compatible); data, measurement, complaint management program and reporting requirements and data submissions. Maintaining laboratory accreditation is directed by:

· Veterans Health Administration (VHA) Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining The Joint Commission (TJC) accreditation

· VHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Service (PLMS)

1.3 Objectives: The objective of this requirement is to supply accreditation services for specified VA clinical laboratories and community-based outpatient centers (CBOCs). Maintaining laboratory accreditation is a requirement under CLIA and required for hospital JC accreditation. Accreditation is consistent with one of P&LMS strategies under quality improvement. Laboratory accreditation confers recognition that a laboratory meets certain standards of quality and safety, and also confers deemed compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial.

1.4 Scope: This requirement includes inspection, quality assessment and laboratory accreditation services for the defined FDA complexity levels (high and moderate), at specified VHA laboratories and CBOCs, where patient testing is performed. Specialties/subspecialties (in language/terms referenced on CMS, Clinical and Laboratory Standards Institute (CLSI), and Good Laboratory Practice (GLP) public websites) that fall under this requirement include:

· Specialties – Chemistry, Clinical Cytogenetics, Diagnostic Immunology, Hematology, Histocompatibility, Immunohematology, Microbiology, Pathology, and Radiobioassay

· Subspecialties - Bacteriology, Blood Gas, Coagulation, Cytology, Donor Specimen, Endocrinology, Flow Cytometry, General Immunology, Genetic testing, Hematology, Histocompatibility, Histopathology, Electron Microscopy, Immunohematology, Immunohistochemistry, Molecular Biology, Molecular Microbiology, Mycobacteriology, Mycology, Oral Pathology, Parasitology, Point of Care Testing, Routine (Chemistry), Syphilis Serology, Toxicology, Urinalysis, and Virology

· Quality Oversight -Safety, Specimen Collection, Laboratory Computer Services, Telepathology, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy

Currently there are approximately 265 VHA patient testing sites (clinical laboratories and CBOCs) that utilize inspection, quality assessment, and laboratory accreditation services under this requirement. 222 sites are high complexity, and 43 are moderate complexity as categorized by FDA. All VHA labs are required to be inspected by the same checklist/standards (regardless of complexity) for consistency across laboratories. VHA patient testing sites are currently located in the contiguous 48 states as well as Alaska, Hawaii, Philippines, and Puerto Rico. During this contract’s period of performance, the total number of inspections, quality assessment, and laboratory accreditation sites is not expected to change more than 10%.

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

See Technical Exhibit A for Laboratory Name, Location, Accreditation Expiration Date, CLIA Number, and Complexity Level and Facility type.

See Technical Exhibit B for Laboratory Specialty/Sub-specialty with Annual Volume.

1.5 Period of Performance: The period of performance shall be for one base period and Three (3) 12-month option years. The Period of Performance reads as follows:

1.6 Quality Control: The Quality Assurance Surveillance Plan (QASP) is provided in Attachment 1.

1.7 Recognized Holidays: The contractor is not required to perform services on the following Federal holidays.

1.8 Hours of Operation: The Contractor is responsible for conducting business between the hours of 08:00 – 4:30 (standard local time for the facility being accredited), Monday thru Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.9 Place of Performance: The work to be performed under the resulting contract will be performed at VHA facilities requiring accreditation as set forth on Technical Exhibit A and at the Contractor facilities.

1.10 Type of Contract: The government will award a Firm Fixed Price Contract.

1.11 Security Requirements: Contractor personnel performing work under this contract will comply with all Privacy and Security training required by VHA as follows:

GENERAL

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

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

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this requirement or information developed by the contractor/subcontractor in performance or administration of the requirement 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).

b. 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.

c. Prior to termination or completion of the resultant contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this requirement 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.

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 resultant 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 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.

f. 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.

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, shall 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 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.

l. 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.

SECURITY INCIDENT INVESTIGATION

a. 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 COR and simultaneously P&LMS Central Office, 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.

b. 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.

c. 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.

d. 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

a. 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.

b. 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.

c. 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.

d. 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 $37.50 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.

TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

1.12 Physical Security: The Contractor shall be responsible for safeguarding any government equipment, information and property provided for contractor use.

1.13 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5.

1.14 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: ensure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.15 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. All contractor employees will wear name badges identifying them as employees of the contractor.

1.16 Contractor Travel: The Government anticipates travel to perform the tasks associated with the effort, as well as to attend an annual program-related conference or provide training for regional medical technologists during the period of performance. Include all estimated travel costs in your firm-fixed price line items.

1.17 Organizational Conflict of Interest: Contractor personnel performing work under this requirement may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

Part 3. Definitions:

3.1.1. On Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories whose current accreditation expires during the contract Period of Performance. This service includes one unannounced on-site inspection (which must occur prior to current expiration date) followed by written notification of contractor decision to reaccredit or revoke accreditation (which must be provided to the Government no more than 90 calendar days from date of on-site inspection).

3.1.2. Out of Cycle Inspection, Quality Assessment, and Laboratory Accreditation services: Contractor provided Accreditation support services with quality oversight program/standards for VHA laboratories identified as requiring additional on-site inspection(s) during the contract Period of Performance. This service includes one on-site inspection, in addition to a routine on-cycle inspection, (which may be announced and must occur within 6 months of government request or date mutually agreed upon between contractor and COR/P&LMS Central Office liaison) followed by written notification of contractor decision to (re)accredit, revoke, or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

3.1.3 Initial Inspection, Quality Assessment, and Laboratory Accreditation services Contractor provided Accreditation support services with quality oversight program/standards for any new VHA laboratory or any VHA laboratory whose complexity increases from waived to non-waived during the contract Period of Performance. This service includes one on-site inspection (which may be announced and must occur within 6 months of government request) followed by written notification of contractor decision to accredit or deny accreditation (which must be provided to the government no more than 90 calendar days from date of on-site inspection).

3.1.4 ON-SITE INSPECTION. A physical review of laboratory practices performed by the contractor’s inspection team.

3.1.5 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime contractor.

3.1.6. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government. See Federal Acquisition Regulation 2.101(b).

3.1.7. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract. See Federal Acquisition Regulation 2.101(b).

3.1.8. DELIVERABLE. Anything that can be physically or electronically delivered. Deliverables that are not separately priced (NSP) shall be included shall be included in the Laboratory Accreditation service cost. Deliverables shall be shipped Freight of Board (FOB) destination.

3.1.9. INSPECTION TEAM. A group used by the contractor to perform on-site inspections. Must include a licensed pathologist certified by the American Board of Pathology for 1) all Veteran Affair Medical Centers “VAMC” and 2) all testing sites performing Anatomic Pathology services. All inspection team personnel shall meet one of the following criteria and be verified by the contractor. Documentation of evaluation of inspection team members shall be provided to PLMS upon request.

· Currently performing patient testing duties in an accredited laboratory that provides services in the specialties/subspecialties they inspect; or

· Board certified by a nationally recognized organization for the specialties/subspecialties they inspect and have a minimum of 1-year previous working experience in an accredited laboratory that provided services in the specialties/subspecialties; or

· Meet CLIA test personnel requirements for the specialties/subspecialties they inspect and have a minimum of 3 years previous working experience in an accredited laboratory that provided services in the specialties/subspecialties; or

· Have a minimum of 5 years of experience providing inspection, quality assessment, and laboratory accreditation services for a CMS approved accrediting organization that provides inspection, quality assessment, and laboratory accreditation services in the specialties/subspecialties they inspect

3.1.10 NORMAL BUSINESS HOURS: 8:00 AM to 5:00 PM EST Monday through Friday, except on Federal Holidays.

3.1.11. INSPECTOR TRAINING. Training provided to government staff, by the contractor, that is consistent with training provided to contractor’s inspectors, as evidenced by contractor generated inspector training certificate or letter. Training shall occur at the contractor’s facility, the trainee’s duty location, or electronically (i.e., web-based training module). Contractor shall provide successful trainees documented evidence of contractor’s certification for laboratory accreditation inspector training within 30 days of completing training.

3.1.12. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

3.1.13. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

3.1.14. QUALITY CONTROL PLAN. All necessary measures taken by the Contractor to ensure that the quality of an end product or service shall meet contract requirements.

3.1.15. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

3.1.16. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

3.1.17. WORK WEEK. Monday through Friday, unless specified otherwise.

PART 4. Summary of Requirements:

4.1 Description of Duties. The Contractor shall:

4.1.1. Provide Laboratory Accreditation Program Services. The program shall include supporting services and a contractor developed quality oversight program or contractor developed quality standards for all specialties/subspecialties (Technical Exhibit B) offered at any VHA laboratory or CBOCs (Technical Exhibit A) where patient testing is performed during the period of performance.

A. Supporting Services shall include:

i. Assigning a senior level liaison (and alternate) who shall have full authority to act for the contractor (i.e., resolve disputes, sign documents, etc) on all matters relating to this contract which includes overseeing the performance of the contract account manager. The name and contact information for the senior level liaison (and alternate) shall be designated in writing to the Contracting Officer and COR. Liaison shall be available during normal business hours.

ii. Assigning a contract manager (and alternate) who shall assist P&LMS Central Office staff with troubleshooting and resolving any concerns relating to the daily performance of this contract. The name and contact information for the Contract Manager (and alternate) shall be designated in writing to the Contracting Officer and COR. Liaison shall be available during normal business hours.

iii. Providing one contractor personnel to present current information regarding the contractor’s inspection, quality assessment, and laboratory accreditation program at the P&LMS annual conference if extended an invitation by the government.

iv. Providing a method for VHA general laboratory staff to receive live (not automated) technical support and/or customer service from the contractor, during normal business hours.

v. Providing a method for VHA general laboratory staff to access/obtain contractor-published laboratory accreditation material, documents, forms, educational opportunities during and outside of normal business hours.

vi. Providing a method for P&LMS Central Office staff to access/obtain VHA laboratory account information during and outside of normal business hours.

vii. Providing a method for the contractor to notify the laboratory director/manager, regional medical technologists, and P&LMS Central Office office in writing (mailed or electronic) if any new standards, revised, or updated accreditation information become available.

viii. Providing an electronic method (i.e., secure website, fax, email) for receipt of VA furnished correspondence.

ix. Providing standardized checklists/standards by which all VHA laboratories are required to be inspected by (regardless of complexity) for consistency across laboratories.

B. Quality Oversight/Quality Standards shall include:

i. Processes equivalent to those submitted to and approved by CMS for which contractor obtained laboratory accreditation “granting” authority.

ii. A Quality Control Plan (QCP) as described in Part 5.

iii. Hard (non-electronic) master copies of laboratory accreditation material provided by the contractor and electronic master copies in Microsoft Word compatible format.

iv. Standardized written document identifying any deficient finding for any (identified) standard or requirement for all on-site inspections.

v. Standardized documents serving as written notification of contractor’s decision to accredit (a laboratory). The document must identify, at minimum, the laboratory’s name and address, the contractor’s assigned laboratory identifier, and the laboratory’s accreditation expiration date.

vi. Standardized written formats (for VHA specialties/subspecialties) for laboratory accreditation materials provided by the contractor. This includes language used and general/common laboratory requirements (i.e., safety, laboratory automation and informatics, quality management, method evaluation, personnel, equipment).

vii. Method to obtain and resolve concerns initiated by VHA general laboratory staff regarding quality of services performed by the contractor and/or quality of services/testing performed in any specialty/subspecialty of the laboratory where patient testing is performed during the period of performance.

viii. Method for providing electronic deliverables to P&LMS Central Office in a Microsoft Word and/or Access compatible format (i.e., XML), as applicable.

ix. Process to ensure that only P&LMS Central Office is notified of the scheduled date for unannounced or announced on-site inspections (ie., date of unannounced inspection remains confidential).

x. Process to maintain, query, analyze, and/or generate reports for any work performed or any (facility) information/data furnished by the government under this requirement.

See Technical Exhibit A which lists the facilities’ CLIA number and complexity level. See Technical Exhibit B which lists the facility’s specialty, subspecialty and annual test volumes

4.1.4. Perform INITIAL INSPECTION, QUALITY ASSESMENT, AND LABORATORY ACCREDITATION SERVICES, defined under 3.1.3, within 6 months of Government request utilizing INSPECTION TEAM assembled in accordance with criteria defined under 3.1.10.

4.1.5 Provide Inspector training, as needed, for a minimum of 10 P&LMS Central Office staff. Training shall be consistent with training provided to contractor inspectors. Training should be provided by the contractor upon request.

4.1.6. Provide a transition plan sufficient to provide continuous accreditation and service and to ensure all laboratories are inspected for accreditation…