S02 - RFQ 36C25622Q0130 - Sterile Processing Tech Services v4.pdf

PAGE 1 OF 75 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

580-21-3-047-0266

36C25622Q0130 12-14-2021

Steven Berkeley, Contract Specialist 713-791-1414 ext.21345 12-28-2021

4pm CDT

36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030-4298

X

561320

$30 Million

N/A

36C580

Department of Veterans Affairs

Michael E. DeBakey VA Medical Center

Receiving Warehouse Building 100

2002 Holcombe Boulevard

Houston TX 77030-4298

36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

Houston TX 77030-4298

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

Invoice Setup Information 1-877-489-6135

Invoice must be submitted electronically

Setup 1-877-489-6135 N/A

See CONTINUATION Page

This solicitation is a request for quote (RFQ) for Onsite

Sterile Processing Technician Services. The Government intends to award a fixed price Indefinite Delivery

Indefinite Quantity (IDIQ) contract. Contractor shall provide all necessary personnel, supervision, labor, equipment and materials to provide services to the Michael E. DeBakey VA

Medical Center, Houston TX in accordance with the Performance

Work Statement (PWS).

For solicitation submission requirements and evaluation factors for this solicitation reference page 50 and page 58.

This acquisition is in accordance with Federal Acquisition

Regulation (FAR) 12,13,13.5, and 16.504.

See CONTINUATION Page

X 1 (One)

Frank Mendoza

VA-VHA-2021-60E358EC

36C25622Q0130

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 PERFORMANCE WORK STATEMENT (PWS)

B.5 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

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

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

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

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D.2 PAST PERFORMANCE QUESTIONNAIRE

D.3 SERVICE CONTRACT ACT WAGE DETERMINATION

D.4 CONTRACTOR CERTIFICATION IMMIGRATION CERTIFICATION

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (SEP 2021) . 46

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (Addendum)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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: POC Name: _________________ Address: ___________________ Phone: _____________________ Email: ______________________ DUNS Number: ______________ Tax ID Number: ______________

b. GOVERNMENT: Frank Mendoza, Contracting Officer 36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030-4298

Phone: 713-791-1414 ext. 22769

E-mail: francisco.mendoza@va.gov

Steven A Berkeley, Contract Specialist 36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030 4298

Phone: 713-971-1414 ext.21345

E-mail: steven.berkeley@va.gov

Contracting Officer Representative (COR):

Thomas Hewett, Operative Care Line

Department of Veterans Affair

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston, TX 77030-4298

Phone: 713-794-7141

Email: thomas.hewett@va.gov

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

mailto:francisco.mendoza@va.gov mailto:steven.berkeley@va.gov mailto:thomas.hewett@va.gov

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in the 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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

PERIOD OF PERFORMANCE (Ordering Period):

- Five (5) years (60 Months) ordering period from the date of award

An initial Task Order for Services will be issued by the VA Contracting Officer (CO) at the beginning of the contract’s period of performance (POP). The Task Order will be emailed to the

Contractor and will include quantities of services needed from the Task Order POP. The VA anticipates funding on Task Order per 12-months. If the value of the particular Task Order needs to be increased or decreased, a contract Modification will be done to the Task Order by a

VA CO.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2,400.00 CS __________________ __________________

Onsite Sterile Processing Technician Services in Support of The

Michael E. DeBakey VA Medical Center (MEDVAMC), in Houston, TX.

Contract Period: Order period One (1) POP Begin: TBD POP End: TBD

Michael E. DeBakey VA Medical Center (MEDVAMC), in Houston, TX.

Contract Period: Order period Two (2)

Michael E. DeBakey VA Medical Center (MEDVAMC), in Houston, TX.

Contract Period: Order period Three (3)

Michael E. DeBakey VA Medical Center (MEDVAMC), in Houston, TX.

Contract Period: Order period Four (4)

Michael E. DeBakey VA Medical Center (MEDVAMC), in Houston, TX.

Contract Period: Order period Five (5)

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

2,400.00

Minimum Quantity (Guaranteed Minimum): 50 cases

Maximum Quantity: 13,200 cases

Six (6) Month Extension: As indicated in contract clause FAR 52.217-8, the Government will have the option to extend the performance of the contract up to an additional six (6) months when the contractor is provided written notice. Six (6) Months extension pricing will be based on the current ordering period the six (6) months extension is exercised. For purposes of the award of this contract, the Government intends to evaluate the option to extend service under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one (1) to six (6) months, but for no more than a total of six (6) months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same price as those in effect under the contract at the time/period the option is exercised. This evaluation will not obligate the Government to exercise any options under FAR 52.217-8.

B.4 PERFORMANCE WORK STATEMENT (PWS)

Onsite Sterile Processing Technician Services

Michael E. DeBakey VA Medical Center (MEDVAMC)

Section 1: General Information

1.1. General: This is a non-personal services contract to provide Sterile Processing Technician

Services for Michael E. DeBakey VA Medical Center (MEDVAMC), Operative Care Line.

The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract services providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2. Federal Acquisition Regulation (FAR) – Indefinite Delivery Contract (IDC). In accordance with FAR 16.504, Indefinite – Quantity Contracts, this is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract and will be referred to as IDC that will be solicited competitively to contractors for a single award. The contract award’s ordering period will be a firm five (5) years.

1.3. Place of Performance: Michael E. DeBakey VA Medical Center

Houston TX, 77030

1.4. Hours of Operation: MEDVAMC normal hours of duty are from Monday through Friday 7:00 a.m. to 4:30 p.m. Contractor technicians may be requested to perform outside of normal duty hours on Federal Holidays depending on workload and demand of MEDVAMC’s schedule.

Section 2: Scope Objective/Key Personnel

2.1. Contractor must provide all labor, supervision and other items and services necessary to perform the work as defined in this PWS.

2.2. Contractor shall furnish up to eight (8) qualified technicians to support the servicing of Orthopedic Instrumentation within the Sterile Processing Department at MEDVAMC.

Section 3: Applicable Documents

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

21 CFR Part 821 21 Code Federal Regulation Part 821-Tracking Requirements

CMS §482.41(c)(2) Center For Medicare and Medicaid Services Quality Standards

ANSI/AAMI EQ

56:1999/(R) 2008

Recommended Practice for a Medical Equipment Management Program

MVAHS 00-116-12 Use and Reprocessing of RME

SCA DOL Website Service Contract Act (SCA) Directory of Occupations (Fifth Edition) http://www.dol.gov/whd/contracts/sca.htm

Federal (includes VA), State, Local, Industry, Any Legal Doctrine/Permit/Code

Performance shall adhere to any and all legal, code, policy, procedure, standard and any applicable doctrine related to services IAW any and all: Federal, State, Local, Industry or otherwise doctrine therein.

3.2. Glossary. Acronyms used in this PWS are listed below for easy reference:

AQL Acceptable Quality Level

Biomed Biomedical Service

COR Contracting Officer’s Representative

FAR Federal Acquisition Regulation

OR Operating Room

OEM Original Equipment Manufacturer

SPS Sterile Processing Services

MEDVAMC Michael E. DeBakey VA Medical Center

RME Reusable Medical Equipment

DOL Department of Labor

VA Veterans Affairs

HIPAA Health Insurance Portability and Accountability Act

OSHA Occupational Safety and Health Administration

CO Contracting Officer

QASP Quality Assurance Surveillance Plan

IAHCSMM -

CRCST

International Association of Healthcare Central Service Materiel Management – Certified Registered Central Service Technician

Section 4: Performance Requirement

4.1. Contractor technicians shall coordinate the repairs and exchange of instrumentation.

4.1.1. MEDVAMC shall maintain financial responsibility for payment(s) for repairs and exchanges of equipment with other vendor(s).

4.1.2. In the event MEDVAMC surgical volume changes, Contractor shall modify Technical support resources as needed to adequately service the MEDVAMC without intervention required by MEDVAMC or change in the agreed upon per-case cost quoted unit prices.

4.2. Contractor technicians shall be knowledgeable and capable of utilizing computers to include but not limited to - data entry, use of Microsoft Office, VistA, and be capable of learning and or knowledgeable of other applicable software as needed by MEDVAMC or recommended by Contractor (for approval by MEDVAMC) to perform the duties specified herein.

4.2.1. Contractor technicians must obtain and maintain annual certification prior to award or within 90 days after award. Technicians must obtain their IAMCSMM CRCST Certification. In addition, Contractor technicians must successfully complete onsite Stryker’s proprietary training held at Stryker’s National Training Center, located at 6624 Fannin Street, Suite 1500, Houston, TX 77030, that is specific to Stryker’s products. A certificate of completion is received upon successfully completing the training program. Contractor shall provide evidence of Onsite http://www.dol.gov/whd/contracts/sca.htm

Access training provided by Stryker. Failure to provide evidence of access to Stryker’s proprietary access to onsite training shall result in an Offeror not being eligible for award.

4.3. Contractor technicians shall organize and process equipment in the areas specified by MEDVAMC. Technicians shall be able to lift up to 35 lbs. This includes palletizing of equipment and transporting items as needed by MEDVAMC.

4.4. Contractor technicians shall have excellent organizational skills: inventory organization of all equipment within rooms as indicated and required by MEDVAMC to maintain proper reporting and record keeping of all inventory.

4.5. Contractor technicians shall advise MEDVAMC with ways or methods to achieve and improve inventory control management and organization of all related equipment.

4.5.1. Contractor technicians shall analyze instrument usage versus on-hand inventory levels and provide MEDVAMC with recommendations on proper inventory level and surgical volume balance.

4.5.2. Contractor technicians shall implement practices that will result in a reduced repair frequency.

4.6. Contractor technicians shall maintain up to date training certification.

4.6.1 Contractor technicians will locally manage all training documents, competencies and Certificates.

4.6.2 Contractor technicians shall successfully complete the coursework and pass the Level 1 VA SPS Certification within the first 90 days of their hire date.

4.7. Contractor technician responsibilities include decontamination and assembly of Orthopedic and Power/Drills instrumentation sets.

4.7.1. Contractor technicians shall provide proactive proper care and handling, transport, storage, reprocessing and sterilization process for Orthopedic Instrumentation.

4.7.2. Contractor technicians shall provide 24/7 support, being on-site during peak times and offering on-call support for night and weekend coverage.

4.7.3. Contractor technicians will support Orthopedic surgical procedures and the reprocessing of Orthopedic surgical instrumentation sets listed below for the Sterile Processing Department within the MEDVAMC.

Stryker System 7 and System 8 Power Drill Sets Stryker Rem B Sets Stryker Sabo and Precision Instrumentation Sets Stryker S2 and Sumex Drill Sets Stryker Small Joint and Formula Shavers Sets Stryker Pi Neuro and Dental Instrumentation Sets (Starting Day 30) Stryker Total Knee Instrumentation Sets (Starting Day 30) Stryker Total Hip Instrumentation Sets (Starting Day 30) Miscellaneous Joint/Loaner Sets (Starting Day 60) Zimmer Total Instrumentation Sets (Starting Day 60)

4.8. Contractor technicians are prohibited from performing or participating in direct patient contact, opening of sterile supplies, handling of any prescription or non-prescription medication for any purpose, advising staff or surgeons on the use of any medical devices in a medical procedure and sterilizing any instrument or device or validating the sterility of any instrument or device.

4.8.1. Contractor technicians are prohibited from initiating the sterilization process.

Section 5: Deliverables

5.1. Contractor technicians shall provide certification in the form of technical documentation, original invoice, or service documentation that the quality of updates and upgrades is sufficient to guarantee continued performance and operation of the system listed in this contract.

5.1.1. Contractor technicians will provide Procedural Summary each month

5.1.2. Contractor technicians will provide Trays Assembly analysis each month

5.1.3. Contractor technicians will provide Error reporting analysis each month

5.1.4. Contractor technicians will provide Sterile Processing Technician Services as outlined in the PWS

Section 6: Key Personnel Replacement and Substitution as applicable.

6.1. Requests for approval of substitutions shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitutions. The request shall contain any other information requested or required by the COR to approve or disapprove the request. The CO or his/her authorized representative shall evaluate such requests and promptly notify the contractor in writing whether the proposed substitution is acceptable.

6.2. If the CO determines that, (1) suitable and timely replacement of personnel who have been reassigned, terminated or have otherwise become unavailable for the contract work is not reasonably forthcoming, or (2) the resultant substitution would be so substantial as to impair the successful completion of the contract or the task order in accordance with the offer accepted by MEDVAMC at time of contract award, the CO may, terminate the contract for cause or for the convenience of MEDVAMC, as appropriate.

Section 8: Management as applicable.

8.1. Contractor shall be responsible for employing technically qualified Onsite technicians to perform the work specified in this PWS. Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

8.2 Contractor Badges. Contractor technicians shall a wear a PIV badge at all times when performing services under this Contract, including when on MEDVAMC directed travel. The PIV badge will contain a personal picture and the Contractor technicians’ name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. It is the contractor’s responsibility to return all contract employee Government Issued Identification Cards/PIV Cards related to this contract in accordance with contract clause 52.204-9 Personal Identity Verification of Contractor Personnel. Last payment will be withheld from the contractor until all PIV cards are returned to the VA to the COR and/or CO. COR and Contractor are responsible to verify and track all Identification Cards/PIV have been returned once contract employee is no longer providing services from this contract.

8.3. Contractor technicians attending meetings, answering MEDVAMC 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 or Congress that they are MEDVAMC officials. They must also ensure that all documents or reports produced by Contractor technicians are suitably marked as contractor products or that Contractor technician’s participation is appropriately disclosed.

8.4. Safety/Security Requirements. Contractor technicians shall comply with all applicable federal, state and local laws and ensure performance is secure while protecting material, equipment, and supplies from damage and loss. MEDVAMC security personnel shall have the express right to inspect for security violations at any time during the term of the contract.

8.5. All information generated in performance of this contract becomes property of MEDVAMC and must be surrendered upon request and/or completion of the contract. Contractor technicians must protect against the destruction and/or misplacement of all information produced under this contract, unless directed under local policy to destroy. This includes both hard and soft copies of data.

8.6. Contractor technicians shall not release any information (including photographs, files, public announcements, statements, denials, or confirmations) on any part of the subject matter of this contract or any phase of any program hereunder without the prior written approval of the COR.

8.7. Standards of conduct.

8.7.1. Conduct of Personnel. Contractor technicians shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor technicians to be removed from the job site if found working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor Onsite Technicians shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of MEDVAMC. The hospital director or designated representative has the authority to bar individuals from MEDVAMC. The removal from the job site or dismissal from the premises shall not relieve Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. MEDVAMC shall not reimburse Contractor for travel and other expenses associated with the removal of personnel.

8.7.2. Contractor technicians are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

8.7.3. Working Attire and Appearance. Contractor technicians shall present a professional appearance commensurate with standards delineated for MEDVAMC civilian personnel acting in similar capacities.

8.7.4. MEDVAMC reserves the right to review Contractor technicians resumes. Upon request, resumes shall be provided to the Contracting Officer prior to clearance approval, for review and acceptance by the COR. The intent is verification purpose and not for MEDVAMC to become the hiring authority.

Section 9: Travel - Not Applicable

Section 10: Non-Personal Service Statement

10.1. Contractor technicians performing services under this contract will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor’s management team will ensure that Contractor technicians properly comply with the performance work standards outlined in the PWS. Contractor technicians will perform their duties independent of, and without the supervision of, any MEDVAMC official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any Contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR).

MEDVAMC will control access to the facility and will perform the inspection and acceptance of the completed work.

Section 11: Personnel Qualifications

11.1. Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. MEDVAMC reserves the right, during the life of the resulting contract, to request work histories on any Contractor technicians for the purposes of verifying compliance with the above requirements. Onsite technicians assigned to, or utilized by, contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner.

11.2. All work shall be completed by technicians in accordance with all applicable Federal, State, Local, and industry: standards, laws, policies, procedures, codes and any other applicable governing body for the proper performance of all equipment per manufactures specifications/calibrations. Contractor is to have proven access to applicable original equipment manufacturers (OEM) parts and manuals, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by, State and local ordinances, with Manufacturer’s Manual and Quality Control Manual, and with all terms, conditions, provisions, schedules, and Specifications provided herein.

11.2.1. Manufacturer trained and certified.

11.2.2. Have a strong knowledge of Medical Terminology, Surgical Procedures, and the reprocessing of Reusable Medical Equipment.

11.2.3. Specialized Experience: Contractor shall provide evidence of factory training for each Onsite Specialists. Contractor Onsite Specialists shall provide technical guidance, education and customer support to the Operating Room, Sterile Processing Department and Biomedical personnel; ensure adherence to management, administrative, operational, and safety requirements of the DOL standard operating procedures. Contractor shall ensure that the equipment and instrumentation functions in conformance with manufacturer specifications.

11.3. Be authorized to work in the U.S.

Section 12: Performance Measures

12.1 Key Personnel:

Performance Requirement: Provide up to eight (8) qualified technicians Standard: Qualified personnel available as needed to properly perform tasks outlined in the

PWS

Acceptable Quality Level: 90% Surveillance Method: Random Inspection, Time and Attendance Sheets, Quality Assurance Incentive: Favorable contractor performance evaluation.

12.2 Shift Coverage:

Performance Requirement: Provide required coverage for contract technicians absence.

Standard: Contractor shall maintain adequate coverage to perform required duties outline in the

PWS

Acceptable Quality Level: 90% Surveillance Method: Random Inspection, Time and Attendance Sheets, Quality Assurance Incentive: Favorable contractor performance evaluation.

12.3 Technician Duties:

Performance Requirement: Contractor Technician(s) shall perform all required duties outlined in section 4 of the PWS Standard: All (95%) contract technician(s) are on time and available to perform duties Acceptable Quality Level: 95% Surveillance Method: Direct Observation Incentive: Favorable contractor performance evaluation.

12.4 Maintain Certification:

Performance Requirement: Updated certification shall be provided as they are renewed.

Standard: All contract technician(s) certification(s) must be current and shall be provided as they are renewed.

Acceptable Quality Level: 95% Surveillance Method: Periodic Inspection Incentive: Favorable contractor performance evaluation.

(END OF PERFORMANCE WORK STATEMENT)

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. 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 and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor 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.

3. VA INFORMATION CUSTODIAL LANGUAGE

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

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable

Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor 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.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart

C, information and system security categorization level designations in accordance with FIPS

199 and FIPS 200 with implementation of all baseline security controls commensurate with the

FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA

Information Security Program). During the development cycle a Privacy Impact Assessment

(PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration

(FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default

"program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST

Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal

Information Systems, VA Handbook 6500, Information Security Program and VA Handbook

6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records

Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of

1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a

SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the

VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A

Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally

Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification

Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the

PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program

Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA

Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf…