36C24621Q0261_1.docx

36C24621Q0261

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

36C24621Q0261 01-26-2021 David E. Smith Contracts Specialist 757-728-7156 02-11-2021

9:00 AM

EST

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X 541990 $16.5 Million N/A X Department of Veterans Affairs Central Virginia Healthcare System Richmond VA 23249 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971 See CONTINUATION Page It is the intention of the Richmond VA Medical Center (VAMC) to solicit offers from capable vendors to provide on-site Laser services, to include a certified technician IAW equipment in section B2. Schedule of Supplies/Services.

The period of performance will be 04/01/2021 to 03/31/2022 for the base year, with four (4) one (1) year options.

See CONTINUATION Page X X Mario L. Santiago Contracting Officer 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: Mario L. Santiago (Contracting Officer)

Hampton VA 23667

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address:

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly 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.

Department of Veterans Affairs Financial Services Center

PO BOX 149971

Austin TX 78714-9971

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

B.2 PRICE SCHEDULE

Laser Services (includes certified technician, all ancillary equipment and fibers requested by surgeons/staff Contractor shall provide Laser Equipment and Technician for the Operating Room at the Central Virginia VA Healthcare System, 1200 Broad Rock Boulevard, Richmond, Virginia 23249 in accordance with all terms, conditions, provisions, and the schedule of this solicitation. Item quantities and amounts are based off 12-month history/volumes.

BASE YEAR – April 1, 2021 – March 31, 2022

Qty

TOTAL COST FOR BASE YEAR: $________________

OPTION YEAR 1 – April 1, 2022 – March 31, 2023

Qty

TOTAL COST FOR OPTION YEAR 1: $________________

OPTION YEAR 2 – April 1, 2023 – March 31, 2024

Qty

TOTAL COST FOR OPTION YEAR 2: $________________

OPTION YEAR 3 – April 1, 2024 – March 31, 2025

Qty

TOTAL COST FOR OPTION YEAR 3: $________________

OPTION YEAR 4 – April 1, 2025 – March 31, 2026

Qty

TOTAL COST FOR OPTION YEAR 4: $________________

TOTAL COST FOR BASE YEAR AND ALL OPTION YEARS: $________________

B.3 PERFORMANCE WORK STATEMENT

1. Background

A. The purpose of this contract is to provide the Central Virginia Healthcare System (CVHCS) with continuous rentals of mobile laser machines assisted by licensed and credentialed technicians to operate the equipment listed in the schedule of services, all ancillary equipment and fibers as requested by the surgeons/staff to complete necessary surgeries. The lasers will be used for urology, ears, nose and throat (ENT) and general surgery in the operating room. An average of 180 laser surgeries annually is anticipated. Cost basis will be based on contractor being reimbursed for actual supplies/services delivered.

Laser surgeries are less intrusive, cause the least amount of risk to the patient and allow for a reduced recovery time for the veteran. Routine procedures will be scheduled during normal business hours. Monday through Friday 8:00 a.m. to 4:30 p.m. Contractor must be able to provide technicians and equipment to operate 4 operating rooms concurrently, when needed and as ordered by the Contracting Officer Representative (COR). Non-routine, emergency services will be required as needed. The technician must be able to arrive at the hospital within 30 minutes of being contacted for emergency surgeries.

2. Objectives

A. With respect to each laser, an overview of this PWS will include the following goals and objectives the CVHCS has a need to continuously rent mobile laser equipment for various surgical procedures. If a laser is inoperable for 60 minutes or more with the result that the designated surgeon must postpone surgical procedures the contractor will forego the charge for that surgical procedure.

3. Scope, Tasks, or Requirements

1. The general scope of the work the contractor will be performing is to supply the Government (CVHCS) with mobile laser equipment to be stored at the facility and a certified and credentialed technician to operate the lasers on specific scheduled days designated by the CVHCS. The certified technician will bring the requested laser directly to the operating room at CVHCS for use in operative procedures. It is expected that all requested lasers meet the inspection criteria of the CVHCS BioMed Department.

1. Technicians shall maintain all applicable qualifications:

· Technician shall have certifications from the manufacturer of the equipment.

· Technicians shall have a minimum of 2 years of experience on the equipment.

· Technician must have completed the Laser Institute of America Medical Laser Safety Officer Training course and the US Medical Education Foundation’s Laser Nurse Specialist Training course or equivalent.

1. The types of lasers and service required by this VA facility include: the Argon Beam Coagulator, Argon Beam Coagulator Stand By, CO2 laser, CO2 laser Stand By, Holmium Laser Low Wattage, Holmium Laser Low Wattage Stand By, Aura XP Laser, Aura XP Laser Stand By, Aura Accustat Fiber, KTP Laser, KTP Laser Stand by, OmniGuide Laser, OmniGuide Laser Stand By, UltraPulse CO2 Laser, UltraPulse CO2 Laser Stand By, XPS Laser, XPS Laser Stand By, Ultrasound, Ultrasound Stand By. Contractor will also provide the necessary attachments, supplies, and fibers needed to operate each laser, including a backup to ensure continuity of service.

1. The lasers must be mobile, and able to accommodate Urologic procedures including, but not limited to, treatment of benign prosthetic hypertrophy (BPH), kidney stones, lithotripsy, excision of lesions, urological resection, irradiation of tumors in the bladder, and treatment of urethral strictures. They must also be able to accommodate ENT procedures including, but not limited to, endoscopic excision of oropharyngeal, hypopharyngeal, supraglottic, glottic, and subglottic resection of mucosal lesions, and facial skin resurfacing.

1. The CO2 laser must have the following specifications: working spot size of 350 microns; sterile fibers; fiber must be able to be used without a handpiece (i.e. can be threaded through flexible bronchoscopes or endoscopes); consistent power output throughout the length of case (can be as long as 3-4 hours); handpieces that have working lengths of 6 cm, 13 cm, 18 cm and 24 cm; handpieces that are straight and bent at the tip of each of the above working lengths; ability to vary the power level and spot size control to allow for superficial peeling, fine cutting, ablation and coagulation, and cutting.

4. Selection Criteria

A. The objective standard of acceptable performance that is to be provided by the contractor is to have a certified and/or licensed technician on the premises, readily available, on the day when the procedure(s) is/are being performed. The contractor should also acknowledge that the laser is in good working condition and is regularly maintained. The contractor will be liable for damages should patient injury result due to laser malfunction. The contractor must also indicate that enough insurance coverage is maintained for its employees and for its equipment.

5. Delivery Schedule

A. The contractor shall store all laser(s) at the CVHCS. The CVHCS shall afford the contractor not less than 24 hours telephone notice of the time of the first procedure. The contractor may remove the laser at the conclusion of the last scheduled surgical procedure and place it back to the storage area. Both the CVHCS and the contractor may, in the event of an emergency, cancel a scheduled day by 24 hours advanced telephone notice to the other. As an alternative, the party giving notice may request that the CVHCS and the contractor adopt an alternative time or site. Because of the contractor’s itinerary and because of CVHCS patient commitments, the rights to cancel and to request change may be exercised sparingly.

B. Usage – The CVHCS shall utilize the contractor’s laser for all surgical procedures for which such laser is designed.

6. Government-Furnished Equipment and Government-Furnished Information A. The CVHCS certifies that each surgeon designated by the VA to operate the laser is trained and competent in the use of that laser in his or her surgical capacity. The CVHCS maintains a facility adequate and suitable for the operation of the laser. CVHCS shall perform or cause to be performed all medical services, supervision, diagnosis and patient care in accordance with all applicable professional standards. Further, each designated surgeon shall protect the laser from injury (including attempted modification) and shall be liable to the contractor for damages occasioned by improper use or handling, carelessness or neglect of the equipment.

B. The contractor will have a certified and/or licensed technician on the premises, readily available, on the day when the procedure(s) is/are being performed. Only CVHCS’s employees, while in the performance of their official duties, and not the contractor’s employees, are covered by the Federal Tort Claims Act, 28 U.S.C. §1346(b), 2671 through 2680. The contractor acknowledges that the laser is in good working condition and is regularly maintained. The contractor will be liable and indemnify the CVHCS for damages should patient injury result due to laser malfunction. The contracted vendor acknowledges that it maintains enough insurance coverage.

7. Place of Performance A. This work will be performed at a Government site and the address is 1201 Broad Rock Blvd, Richmond Virginia 23249 (specifically in the CVHCS operating rooms) and not at the contractor’s site.

8. Period of Performance

A. The performance period will be April 1, 2021 to March 31, 2022 plus 4 option years.

9. Contractor’s Responsibility

A. The contractor shall perform services under the direction of the Central Virginia VA Healthcare System Chief of Staff, Chief, Surgical Care Service Line, Section Chief Urology Service Line. Section Chief Ear, Nose, and Throat (ENT) Service Line. Section Chief Plastics Service Line and Section Chief General Surgical Services Line.

B. Contractor will hold and submit certificates of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Under no circumstances are Contractor’s employees considered CVHCS employees.

C. Technician(s) must be licensed to provide medical services in the State of Virginia and have laser safety training and certificate.

· Technicians shall maintain required licensing, registration and certification; records shall be provided to keep records current. Technicians shall maintain required licensing, registration and certification throughout the life of the contract.

D. Contractor shall complete all required training per CVHCS policies.

· Technicians shall meet all VA educational requirements and mandatory course requirements defined in the contract and additional as directed by the CVHCS.

E. Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality.

· All (100%) Contractor’s physician(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA.

F. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs, and upgrades to the equipment as required keeping it in optimal condition.

G. Technician(s) are subject to the same quality assurance standards as established by the Joint Commission (JC).

H. The Contractor will provide services in accordance with ethical, professional and technical standards of the health care industry.

I. All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident. Patient safety incidents shall be reported to Circulating Nurse and should be documented using Patient Safety Report Process (JSPR). All incidents reported immediately (within 24 hours).

J. Contractor shall ensure that the equipment is operational and includes all required ancillary supplies and attachments. All required laser surgeries are supported with a primary and backup machine.

K. Technician arrives on time to perform the required services

· Technicians shall arrive at a minimum of 30 or arrive with enough time for setup.

· Technicians shall arrive at the hospital within 30 minutes during weekend/emergency/afterhours notifications.

L. Technician shall provide all aftercare as required.

· All required aftercare for the equipment utilized during their procedures.

M. Technician shall have a positive performance record with the contractor.

· Contractor shall maintain a record of positive performance of the technician and provide upon request.

10. Services Not Covered

A. Any work other than as specified in the contract shall be identified as a non-priced task, and if determined by the Contracting Officer to be within the overall scope of the contract, work shall be added by a modification to the contract.

B. Any work requested that is identified as outside the scope of the contract shall be addressed by the facility as a separate procurement

B.4 SPECIAL CONTRACT REQUIREMENTS

Under the authority of Public Law 104-262 and 38 USC 8153, the contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs Medical Center, the services and prices specified in the Section entitled Schedule of Supplies/Services of this contract.

1. SERVICES:

1. The services specified in Section B. - Schedule of Supplies/Services may be changed by written modification to this contract. The modification shall be prepared by the Contracting Officer (CO) and, prior to becoming effective, shall be signed by both parties.

1. The Government reserves the right to refuse acceptance of the contractor’s employees, if personal or professional conduct jeopardizes patient care. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and Contracting Officer’s Representative (COR) shall deal with issues raised concerning contract personnel’s conduct. The final arbiter on questions of acceptability is the CO.

1. The CO shall resolve complaints concerning the contractor employee relations with the Government employees or patients. The CO is the final authority on validating complaints. If the contractor employee is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse. In the event the contractor employee effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

1. Contractor shall, in writing, keep the CO informed of any unusual circumstances in conjunction with the contract.

2. TERM OF CONTRACT:

This contract is effective from April 1, 2021 to March 31, 2022 with four (4) one-year options. The contract is subject to the availability of funds. The contractor shall perform no services after March 31, of each year unless the Contracting Officer authorizes such services in writing.

a. The CO will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the CO, the change shall be considered unauthorized by the local VAMC and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

b. The COR will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

3. QUALIFICATIONS:

Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

4. WORK HOURS: As needed as scheduled by the COR

The services covered by this contract shall be furnished by the contractor as defined herein.

Contractor shall provide services Monday through Friday 8:00 a.m. to 4:30 p.m. for routine procedures as scheduled. Emergency procedures could be required outside of normal business hours and include arriving at facility 30 minutes from time of notification of emergency procedures. Scheduling of non-emergency services within 24 hours and must have the equipment and technicians available to complete four (4) or more procedures simultaneously.

National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day Martin Luther King’s Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas

And any other day specifically declared by the President of the United States to be a National holiday.

5. PERSONNEL POLICY:

The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel:

- general liability

- workers compensation

- professional liability insurance

- health examinations

- income tax withholding, and

- social security payments.

The parties agree that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

6. RECORD KEEPING:

a. Contractor’s employee(s) shall report to the COR, upon arrival at the VA Medical Center. VAMC personnel shall brief Contractor employee(s) on VAMC policies and procedures on the first scheduled duty day. Contractor shall abide by VA Handbook 6300.1 located: http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2

b. The VAMC will establish and maintain a record keeping system that will record the services performed by the Contractor’s employee(s). This recordkeeping system shall consist of time and attendance reports to ensure that required services have been received by the VA Medical Center. Any incidents of Contractor non-compliance as evidenced by the monitoring procedure shall be forwarded immediately to the Contracting officer.

1. Documentation of services performed shall be reviewed prior to certifying payment. Contractor shall be present at the VAMC and shall be performing the required services as specified in the task order in order to receive reimbursement. The VAMC shall pay for services performed and in strict accordance with B2, Schedule of Supplies/Services above. Contract monitoring and record keeping procedures shall be enough to ensure proper payment and allow audit verification that services were provided.

7. MANAGEMENT AND SUPERVISION:

1. The Contractor shall be responsible for supervising the daily services provided under this contract by the Contractor’s staff.

1. The VAMC will provide to the Contractor policies, procedures and processes necessary to allow cooperative functioning between the agency and VAMC. Updates and refreshers will be provided to the Contractor upon request and when policy procedures or process changes.

1. The Contractor shall complete background investigations to ensure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

1. Contractor shall follow the COR delegation of authority relative to any aspect of the contract. Contractor agrees he/she shall not directly or through his/her dealers solicit the beneficiaries of the Department of Veterans Affairs. The Contractor is to contact the patient or caregiver only to make arrangements for rendering services or supplies authorized by VA.

8. CONTRACTING WITH PARTIES LISTED ON THE OIG LIST OF EXCLUDED INDIVIDUALS/ENTITIES:

a. In accordance with The Health Insurance Portability and Accountability Act (HIPAA) and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

b. Therefore, all offerors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed candidate(s) and/or firm(s) are not listed. Offerors should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a minimum and maximum Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against health care providers and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

c. By signing the offer, the Contractor certifies that he/she has reviewed the OIG List of Excluded Individuals/Entities and that the proposed candidate(s) and/or firm are not listed as of the date the offer was signed.

9. TORT CLAIMS:

Individual(s) providing the services under the contract are not covered by the Federal Tort Claims Act. When an individual(s) providing the services has been identified as a provider in a tort claim, the individual(s) providing the services is responsible for notifying the Contractor’s legal counsel and/or insurance carrier. Any settlement or judgment arising from an individual(s) providing the services action or non-action is the responsibility of the Contractor and/or insurance carrier.

10. ADP SECURITY RESPONSIBILITIES:

In performance of official duties, the Contractor’s employee(s) have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. The Contractor’s employee(s) are responsible for (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion and (2) following all applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in a computer access agreement which the Contractor’s employee(s) signs.

11. CONFIDENTIALITY OF PATIENT RECORDS:

a. The Contractor is a VA contractor and shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for VA records access and patient confidentiality, Contractor is a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department and not withstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

b. The records referred to above shall be and remain the property of the VA and shall not be removed or transferred from VA except in accordance with U.S.C. 551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimant’s records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. 7332 (Confidentiality of Certain Medical Records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

12. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA):

In accordance with 45 CFR 164.502(e), the Privacy Rule includes exceptions to the Business Associate standard. This contract and its requirements meet the following exception and do not require a Business Associate agreement for Covered Entity to disclose Protected Health Information to a health care provider for treatment. Based on this exception, a Business Associate agreement is not required for this contract. The Contractor must adhere to all VA security policies and applicable confidentiality statutes, include 38 U.S.C. 5701, 38 U.S.C. 5705, 38 U.S.C. 7332, 5 U.S.C. 552a (Privacy Act), as well as 45 U.S.C. Parts 160, 162 and 164 (Health Insurance Portability and Accountability Act).

13. CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS):

a. FAR 42.1502 direct all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted to record your contract performance as required by FAR 42.15.

b. The past performance evaluation process is a totally paperless process using CPARS.

CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

c. Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm’s past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state if the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

d. When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically generated email with detailed login instructions. Further details, system requirements, and training information for CPARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.

e. You have 14 calendar days following the Assessing Official signature date to submit comments before the evaluation is made available in the Past Performance Information Retrieval System (PPIRS). You have a total of 60 calendar days following the Assessing Official signature date to submit comments. Any comments that you submit will be posted to PPIRS. If you do not sign and return the evaluation within 60 calendar days the evaluation will be returned to the Assessing Official, you will no longer be able to provide comments and the evaluation will be annotated as follows: 'The report was delivered/received by the contractor on (date). The contractor neither signed nor offered comment in response to this evaluation.' Partially completed comments that were not signed and returned to the Government within 60 calendar days will be removed from the evaluation.

f. The following guidelines apply concerning your use of the past performance evaluation:

(1) Protect the evaluation as “source selection information.” After review, transit the evaluation by completing and submitting the form through CPARS. If for some reason you are unable to view and/or submit the form through CPARS, contact the Contracting Officer for instructions.

(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, pre-award surveys, responsibility determination, production readiness reviews, or other similar purposes.

g. If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven (7) days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30-day review period.

h. A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.

14. CONTRACTOR CERTIFICATION

Citizenship-related requirements: Contractor must return a signed certification as found in Section D of this solicitation. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

15. INFECTION CONTROL REQUIREMENTS:

Contractor shall provide proof of the following tests within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

a. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to Purified Protein Derivative (PPD) testing. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

b. RUBELLA TESTING: Contractor shall provide proof of immunization for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the Contracting Officer’s Representative (COR).

c. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training; provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

d. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. The Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (AJIC 1998; 26:289-354) for disease control. The Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

16. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security Investigations Center prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract, the contractor shall be responsible for the actions of those individuals they provide to perform work for the VA.

a. Position Sensitivity – The position sensitivity has been designated as LOW-RISK

b. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check with written inquiries.

c. Contractor Responsibilities

(1) The VA Security Investigations Center will provide the necessary forms to the contractor or to the contractor’s employees after receiving the required information.

(2) Upon receipt, the VA Security Investigations Center will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

(3) The VA facility will pay for investigations conducted by the Office of Personnel Management (OPM) in advance. The contractor will reimburse the VA facility. The cost of investigation(s) will be $333.00 for each provider and will be held from the first invoice submitted by the contractor. In the event a provider has a reciprocal background investigation on file, the contractor will reimburse the VA facility $333.00 per provider for processing of Special Agreement Checks (SAC) (fingerprinting).

(4) The VA Security Investigations Center will notify the contracting officer after adjudicating the results of the background investigations received from OPM.

Further Instructions regarding the background investigation process and procedures will be provide at time of award.

17. CONTRACTOR SECURITY REQUIREMENTS:

a. All Contractors and Contractor personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA, and VA personnel, regarding information and information system security. Contractor must follow policies and procedures outlined in VA Directive 6500, Information Security Program and its handbooks to ensure appropriate security controls are in place.

http://www.iprm.oit.va.gov/docs/VA_Handbook_6500_6_Contract_Security_030210_Final.pdf

18. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE:

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.

19. 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.

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 following 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 patients’ sensitive 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 enough 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.