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36C25919R0020
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
36C25919R0037 11-28-2018 Jen Callahan 303-712-5765 12-07-2018
36C259 Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111
X
561320 $27.5 Million
N/A
Department of Veterans Affairs Rocky Mountain Regional VA Medical Center 1700 N Wheeling St Aurora, CO 80045 36C259 Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111
Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971
See CONTINUATION Page Surgical Laser Services & Instrumentation
Performance Period: April 1, 2019 - March 31, 2020 plus four option years
Submit your proposal in accordance with FAR 52.212-2 and be sure to complete the pricing schedule in Section B.3.
See CONTINUATION Page
Table of Contents
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011) | 5 |
| B.3 PRICE/COST SCHEDULE | 5 |
| ITEM INFORMATION | 5 |
| B.4 PERFORMANCE WORK STATEMENT | 8 |
| B.4 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011) | 22 |
| SECTION C - CONTRACT CLAUSES | 24 |
| C.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018) | 24 |
| C.2 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011) | 30 |
| C.3 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014) | 34 |
| C.4 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON RECYCLED PAPER (MAY 2011) | 34 |
| C.5 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011) | 34 |
| C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 35 |
| C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 35 |
| C.8 52.224-1 PRIVACY ACT NOTIFICATION (APR 1984) | 36 |
| C.9 52.227-14 RIGHTS IN DATA—GENERAL (MAY 2014) | 36 |
| C.10 52.232-18 AVAILABILITY OF FUNDS (APR 1984) | 40 |
| C.11 52.237-3 CONTINUITY OF SERVICES (JAN 1991) | 41 |
| C.12 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) | 41 |
| C.13 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 2008) | 41 |
| C.14 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) | 42 |
| C.15 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) | 43 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 45 |
| D.1 Quality Assurance Surveillance Plan | 45 |
| D.2 Business Associate Agreement | 49 |
| SECTION E - SOLICITATION PROVISIONS | 54 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017) | 54 |
| E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 58 |
| E.3 52.216-1 TYPE OF CONTRACT (APR 1984) | 58 |
| E.4 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION) | 59 |
| E.5 52.217-5 EVALUATION OF OPTIONS (JUL 1990) | 59 |
| E.6 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) | 59 |
| E.7 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO BENEFICIARIES (JAN 2008) | 59 |
| E.8 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003) | 60 |
| E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2017) | 60 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C259 Jennifer Callahan Department of Veterans Affairs Network Contracting Office
NCO 19
6162 South Willow Drive, Suite 300 Greenwood Village CO 80111
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [] |
| 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 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 Service 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:
| AMENDMENT NO |
| DATE |
B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)
The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.
B.3 PRICE/COST SCHEDULE
ITEM INFORMATION
Base Year: April 1, 2019 – March 31, 2020
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| BPH Laser with Technician |
| 12 |
| EA |
| 0002 |
| CO2 Laser with Technician |
| 12 |
| EA |
| 0003 |
| Cryo with Technician |
| 10 |
| EA |
| 0004 |
| Holmium with Technician |
| 12 |
| EA |
| 0005 |
| KTP Laser with Technician |
| 11 |
| EA |
| 0006 |
| Omniguide Laser with Technician |
| 17 |
| EA |
| 0007 |
| Uronav Equipment with Technician |
| 2 |
| EA |
| 0008 |
| Ultrasound Equipment with Technician |
| 2 |
| EA |
GRAND TOTAL
Option Year 1: April 1, 2020 – March 31, 2021
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| BPH Laser with Technician |
| 12 |
| EA |
| 0002 |
| CO2 Laser with Technician |
| 12 |
| EA |
| 0003 |
| Cryo with Technician |
| 10 |
| EA |
| 0004 |
| Holmium with Technician |
| 12 |
| EA |
| 0005 |
| KTP Laser with Technician |
| 11 |
| EA |
| 0006 |
| Omniguide Laser with Technician |
| 17 |
| EA |
| 0007 |
| Uronav Equipment with Technician |
| 2 |
| EA |
| 0008 |
| Ultrasound Equipment with Technician |
| 2 |
| EA |
GRAND TOTAL
Option Year 2: April 1, 2021 – March 31, 2022
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| BPH Laser with Technician |
| 12 |
| EA |
| 0002 |
| CO2 Laser with Technician |
| 12 |
| EA |
| 0003 |
| Cryo with Technician |
| 10 |
| EA |
| 0004 |
| Holmium with Technician |
| 12 |
| EA |
| 0005 |
| KTP Laser with Technician |
| 11 |
| EA |
| 0006 |
| Omniguide Laser with Technician |
| 17 |
| EA |
| 0007 |
| Uronav Equipment with Technician |
| 2 |
| EA |
| 0008 |
| Ultrasound Equipment with Technician |
| 2 |
| EA |
GRAND TOTAL
Option Year 3: April 1, 2022 – March 31, 2023
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| BPH Laser with Technician |
| 12 |
| EA |
| 0002 |
| CO2 Laser with Technician |
| 12 |
| EA |
| 0003 |
| Cryo with Technician |
| 10 |
| EA |
| 0004 |
| Holmium with Technician |
| 12 |
| EA |
| 0005 |
| KTP Laser with Technician |
| 11 |
| EA |
| 0006 |
| Omniguide Laser with Technician |
| 17 |
| EA |
| 0007 |
| Uronav Equipment with Technician |
| 2 |
| EA |
| 0008 |
| Ultrasound Equipment with Technician |
| 2 |
| EA |
GRAND TOTAL
Option Year 4: April 1, 2023 – March 31, 2024
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 0001 |
| BPH Laser with Technician |
| 12 |
| EA |
| 0002 |
| CO2 Laser with Technician |
| 12 |
| EA |
| 0003 |
| Cryo with Technician |
| 10 |
| EA |
| 0004 |
| Holmium with Technician |
| 12 |
| EA |
| 0005 |
| KTP Laser with Technician |
| 11 |
| EA |
| 0006 |
| Omniguide Laser with Technician |
| 17 |
| EA |
| 0007 |
| Uronav Equipment with Technician |
| 2 |
| EA |
| 0008 |
| Ultrasound Equipment with Technician |
| 2 |
| EA |
GRAND TOTAL
B.4 PERFORMANCE WORK STATEMENT
1. GENERAL
SERVICES REQUIRED: Contractor shall provide qualified surgical laser services and instrumentation for the beneficiaries of the Rocky Mountain Regional VA Medical Center for a base year plus four option years. Services will be provided for the following types of procedures:
| I. | Otolaryngology |
| II. | Urology |
| III. | Ophthalmology |
| IV. | OB/GYN |
| V. | Plastics |
| VI. | General Surgery |
| VII. | Neurosurgery |
| VIII. | Vascular Surgery |
| IX. | Orthopedic Surgery |
| X. | Oncology |
| XI. | Other Procedures as Required |
| 1.1. | PLACE OF PERFORMANCE: RMR VA Medical Center 1700 N. Wheeling St Aurora, CO 80045 |
1.2. AUTHORITY: Public Law 104-262 and 38 USC 8153.
1.3. DEFINITIONS/ACRONYMS
| 2. | QUALIFICATIONS: |
| 2.1. | Staff/Facility |
| 2.1.1. | Board Certification /Eligibility: Technicians must be board-certified and eligible to operate all equipment under all applicable laws and regulations. Proof of certification and continuing education will be provided upon request. |
| 2.1.2. | Technical Proficiency: Technicians must have documented training to run all equipment for procedures listed in Section 1 of the PWS. |
| 2.1.3. | The Vendor shall provide all equipment including disposables related to the technician’s utilization of laser(s) during surgical procedures. |
| 2.1.4. | Contracted services must be available 24/7. |
| 2.1.5. | Training (ACLS/BLS/VA MANDATORY): The Contractor is required to sign the Contractor Rules of Behavior and is required to complete all VA Mandatory training to gain access to systems needed to perform the services required under this contract. |
| 2.1.6. | Standard Personnel Testing (PPD, etc): Contractors will complete all testing as required by VAMC Policy and comply with requests in a timely fashion. |
| 2.1.7. | Citizenship related Requirements: Contractors must be a US Citizen and eligible to work in the United States. |
| 2.1.8. | Annual Office of Inspector General (OIG) Statement: Contractors must comply with all Office of Inspector General (OIG) investigations as necessary per VAMC policy. |
| 2.1.9. | 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: |
| i. | Workers compensation |
| ii. | Professional liability insurance |
| iii. | Health examinations |
| iv. | Income tax withholding, and |
| v. | Social security payments. |
| vi. | The parties agree that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose. |
| 2.2. | TECHNICAL DIRECTION |
| 2.2.1. | Contractors will report directly to the Chief, Surgical Services. |
| 2.3. | NON PERSONAL SERVICES |
| 2.3.1. | No Employee status. The contractor shall be responsible for protecting contractor’s employees. To carry out this responsibility, the contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract: |
| i. | Worker’s Compensation |
| ii. | Professional Liability Insurance |
| iii. | Health Examinations |
| iv. | Income Tax Withholding |
| v. | Social Security Payments |
| 2.3.2. | TORT. Not Applicable. |
2.4 Key Personnel and Emergency Substitutions. During the first ninety (90) calendar days of performance, the contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The contractor shall notify the CO, in writing, within five (%) days after the occurrence of any of these events and provide the information required below.
2.4.1 The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 5 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract may be modified the reflect any approved changes of key personnel.
| 2.4.2 | For temporary substitutions where the key person will not be reporting to work for 3 consecutive workdays or more, the contractor shall provide a qualified replacement for the key person. Any period exceeding two weeks will require the procedure as stated above. |
| 2.4.3 | The government reserves the right to refuse acceptance of any contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. 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 or other staff members to designated government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the COS or designee show documented clinical problems or continual unprofessional behavior/actions with any contractor providers, s/he may request without cause immediate replacement of said contractor provider. The CO and COR shall deal with issues raised concerning contractor’s provider conduct. The final arbiter on questions of acceptability is the CO. |
| 3. | Hours of Operation: |
| 3.1. | Contracted Hours: Contracted services shall be available 24/7. |
| 4. | CONTRACTOR RESPONSIBILITIES |
| 4.1. | SERVICES REQUIRED: The contractor shall provide the services of a certified laser technician(s) to operate laser(s) for specified surgeries including |
| 4.1.1. | Otolaryngology |
| 4.1.2. | Urology |
| 4.1.3. | Ophthalmology |
| 4.1.4. | OB/GYN |
| 4.1.5. | Plastics |
| 4.1.6. | General Surgery |
| 4.1.7. | Neurosurgery |
| 4.1.8. | Vascular Surgery |
| 4.1.9. | Orthopedic Surgery |
| 4.1.10. | Oncology |
| 4.1.11. | Other procedures as required |
| 4.2. | Contractor Employee Responsibilities |
| 4.2.1. | Contractor shall provide, upon request, the employment information on each referred technician including documentation certifying the technician has completed all the requirements necessary to receive a Certificate of Competence in the field of Laser Technology |
| 4.2.2. | Contractor shall provide SOP for laser(s) utilized in the RMR VA Operating Rooms and upon request will provide documentation of laser maintenance and safety. |
| 4.2.3. | Contractor shall be compliant with the American National Standards Institute (A.N.S.I.) Z136.3 Standard for the "Safe Use of Lasers in Health Care Facilities". Laser operators will work under the authority/guidance of the RMR VA Laser Safety Officer (LSO). |
| 4.2.4. | Technicians must be able to read, speak and write English fluently and be a United States citizen. |
| 4.2.5. | Technician must be able to perform the duties of their assignment under normal and emergent conditions. The vendor will be ready to provide urgent and emergent services within 45 minutes of notification by the VA Medical Center Surgical staff should the need arise. For routine requests, the technician shall be on-site within four hours of the VA’s request. |
| 4.2.6. | Technician shall maintain open and professional communication with members of the VA staff, patients and customers. |
| 4.2.7. | Contractor shall provide sufficient personnel who meet all the requirements herein and who can be relied upon to perform in strict accordance with the contract. Personnel shall be competent, qualified and adequately trained to operate surgical lasers. |
| 4.2.8. | Contractor shall provide a point of contact that will be responsible for the performance of the work. |
| 4.2.9. | The VA will conduct criminal background checks on all providers involved in the delivery of surgical laser services. |
| 4.2.10. | With consent from the VA, the laser operator(s) may provide surgical services prior to completion of background checks. However, the laser operator(s) shall be within sight and continuous supervision of a VA staff person whose background check has been completed with a favorable result. |
| 4.2.11. | All laser operators shall present a professional, conservative and neat appearance. Contractor personnel shall report for duty in a professional manner, in appropriate attire befitting a healthcare setting and have complied with socially acceptable standards of personal hygiene expected of a healthcare worker. |
| 4.2.12. | Laser operators shall be current with and have completed all continuing education requirements specified by their professional licensure or certification. |
| 4.3. | MEDICAL RECORDS Patient medical records are confidential and are protected by the Privacy Act of 1974, 5 U.S.C. 552a; VA Claims Confidentiality Statute, 38 U.S.C. 3301 and Drug/Alcohol Abuse Confidentiality Statute, 38 U.S.C. 4132 [Authority: Drug/Alcohol Regs. 42 C.F.R. 2.11(p)(2)]. Any breach of confidentiality and/or unauthorized release of information is subject to monetary penalty. Any individual making unauthorized disclosures may be criminally liable for violations of the Act. |
| 4.3.1. | HIPAA: The contractor must adhere to the provisions of 45 C.F.R. Parts 160, 162, and 164 and Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the 18. |
| 4.3.2. | HHS/OIG: To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Service – Office of Inspector General, List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. National Standards to protect the Privacy and Security of Protected Health Information (PHI). |
| 4.3.3. | Release of Information: The Contractor and contract employees shall only release medical information obtained during the course of this contract to those ECHCS staff member involved in the necessary care and treatment of that individual patient. Contractor shall provide Laser Services to ECHCS patients. As such, Contractor is considered part of the Department health care activity for purposes of the following statutes and the VA regulations implementing these statutes: the Privacy Act, 5 U.S.C. § 552a, and 38 U.S.C. §§ 5701, 5705, and 7332. Contractor and its employees may have access to ECHCS patient medical records to the extent necessary for the Contractor to perform this contract. Notwithstanding any other provision of this contract, Contractor and its employees may disclose patient treatment records generated by the Contractor under this agreement only pursuant to explicit disclosure from ECHCS. Contractor and its employees are subject to the penalties and liabilities provided in the statutes and regulations mentioned in this paragraph for unauthorized disclosures of such records and their contents. Records created by the Contractor in the course of treating ECHCS patients under this agreement are the property of the ECHCS and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Subject to applicable federal confidentiality laws, Contractor or its designated representatives may have access to ECHCS records at ECHCS's place of business on request during normal business hours where necessary to perform the duties under this agreement. If this agreement is terminated for any reason, the Contractor will promptly provide the ECHCS with the individually identified patient treatment records. The Privacy Act applies to certain information about healthcare providers who are subcontractors. If data is retrieved by the names of the individual healthcare professionals, the data the VHA receives is protected by the Privacy Act. Accordingly, the VHA Privacy Officer should be consulted to ensure that ECHCS has a published system of records notice that will cover these records. If not, the Privacy Act requires that such notice be published prior to the maintenance of the records. |
| 4.4. | PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT | |
| 4.4.1. | Methods of Surveillance: Contractors will sign in at the OR office upon arrival/departure for cases. Invoices will specify date/case/number of hours for each service performed. | |
| 4.4.2. | Quality Assurance will be monitored in accordance with VHA Handbook dated February 8, 2007, “Quality Reviews and Surgical Outcomes,” a copy of which shall be maintained in the Surgical Service Office. | |
| 4.4.3. | Performance Standards: The QASP outlines required standards and will be a part of the resultant contract. Performance measures are listed below in section 4.4.6. | |
| 4.4.4. | REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $100,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, the Contractor Performance System (CPS), which is maintained by the National Institutes of Health (NIH). The CPS database information is shared with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. | |
| i. | Each contractor whose contract award is estimated to exceed $100,000 is required to register with the NIH CPS database at the following web address: https://cpscontractor.nih.gov. Help in registering can be obtained by contacting CPS Support E-mail (cps-support-l@list.nih.gov ) or by calling (301) 451-2771. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the contractor’s registered representative. | |
| ii. | For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer. | |
| iii. | Failure to have a current registration with the NIH CPS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond. | |
| 4.4.5. | Contractor Certification | |
| i. | The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals; | |
| ii. | While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. | |
| iii. | If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach. | |
| iv. | The Contractor agrees to obtain a similar certification from its subcontractors. | |
| Signature: | ______________________________________ | |
| Date: | ______________________________________ | |
| Typed Name and Title: | ______________________________________ | |
| Company Name: | ______________________________________ |
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.
4.4.6. Performance Measures
Measure: Qualifications of Key Personnel Requirement: Key-Personnel shall be board-certified and shall possess the qualifications as required by the PWS.
Acceptable Quality Level: 100 %, No Deviations Surveillance Method: Direct Observation Frequency: Annual
Measure: Safety Requirement: Safety incidents shall be reported using the Safety Report form. All incidents are to be reported immediately (within 24 hours of occurrence).
Acceptable Quality Level: 95% Surveillance Method: Direct Observation, Validated Complaints Frequency: Quarterly
Measure: Mandatory Training Requirement: Contractor personnel shall complete all mandatory training per VA policy and in accordance with this PWS.
Acceptable Quality Level: 95% Surveillance Method: Direct Observation, Validated Complaints Frequency: Annual
Measure: Privacy and HIPAA Requirement: Contractor employees shall comply with all laws, regulations, policies, and procedures relating to Privacy, HIPAA, and Confidentiality, and comply with all standards, maintaining no breaches of confidentiality or privacy.
Acceptable Quality Level: 100%, No Deviations Surveillance Method: Direct Observation, Validated Complaints, Periodic Inspection Frequency: Quarterly
| 5. | GOVERNMENT RESPONSIBILITIES |
| 5.1. | Oversight of Service/Performance Monitoring in accordance with the QASP. |
| 5.2. | CO Responsibilities: Jennifer Callahan, 303-712-5765, Jennifer.Callahan4@va.gov |
| 5.3. | The CO is the only person authorized to approve changes or modify any of the requirements of the contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract. |
| 5.4. | The CO shall resolve complaints concerning Contractor’s provider relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor 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. |
| 5.5. | In the event that contracted services do not meet quality and/or safety expectations as determined by the CO, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for the contract staff to be provided by the VA; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract. |
| 5.6. | The COR is MaryEllen Winkler. |
| 5.6.1. | The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor or Contractor’s provider noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. |
| 5.6.2. | The COR will be responsible for monitoring the Contractor staff performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring is outlined in the QASP. |
| 5.6.3. | The COR will maintain a record-keeping system of services by reviewing the QAPI and invoices submitted by the Contractor. The COR will review this data monthly when invoices are received and certify all invoices for payment. Any evidence of the Contractor's non-compliance shall be forwarded immediately to the Contracting Officer. The CO reserves the right to take other appropriate contract action (refer to 52.212-4 Contract Terms and Conditions – Commercial Items). |
| 5.6.4. | The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference. |
| 5.7. | All contract administration functions will be retained by VA. |
| 5.7.1. | Contract Administration: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: |
Jennifer Callahan, Contracting Officer 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Or emailed to Jennifer.Callahan4@va.gov
6. SPECIAL CONTRACT REQUIREMENTS
6.1. BILLING: PATIENT BILLING VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the contractor even if the VA does not pay for those services. This provision shall survive the termination or ending of the contract.
INFORMATION SECURITY/PRIVACY REQUIREMENTS
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/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
c. 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. 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.
c. 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.
d. 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.
e. 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.
f. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted for, using VA-approved encryption tolls that are, at minimum, FIPS 140-2 validated.
g. 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.
h. 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.
4. SECURITY INCIDENT INVESTIGATION
a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
5. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.
b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,00.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
6. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required Privacy and HIPAA Training; and
(3) Successfully complete any additional information security or privacy training, as required for VA personnel with equivalent information system access.
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
7. VA Handbook 6500.6 Appendix D, Contractor Rules of Behavior
CONTRACTOR RULES OF BEHAVIOR
This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA). This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract.
1. GENERAL TERMS AND CONDITIONS FOR ALL ACTIONS AND ACTIVITIES UNDER THE CONTRACT:
a. I understand and agree that I have no reasonable expectation of privacy in accessing or using any VA, or other Federal Government information systems.
b. I consent to reviews and actions by the Office of Information & Technology (OI&T) staff designated and authorized by the VA Chief Information Officer (CIO) and to the VA OIG regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. These actions may include monitoring, recording, copying, inspecting, restricting access, blocking, tracking, and disclosing to all authorized OI&T, VA, and law enforcement personnel as directed by the VA CIO without my prior consent or notification.
c. I consent to reviews and actions by authorized VA systems administrators and Information Security Officers solely for protection of the VA infrastructure, including, but not limited to monitoring, recording, auditing, inspecting, investigating, restricting access, blocking, tracking, disclosing to authorized personnel, or any other authorized actions by all authorized OI&T, VA, and law enforcement personnel.
d. I understand and accept that unauthorized attempts or acts to access, upload, change, or delete information on Federal Government systems; modify Federal government systems; deny access to Federal government systems; accrue resources for unauthorized use on Federal government systems; or otherwise misuse Federal government systems or resources are prohibited.
e. I understand that such unauthorized attempts or acts are subject to action that may result in criminal, civil, or administrative penalties. This includes penalties for violations of Federal laws including, but not limited to, 18 U.S.C. §1030 (fraud and related activity in connection with computers) and 18 U.S.C. §2701 (unlawful access to stored communications).
f. I agree that OI&T staff, in the course of obtaining access to information or systems on my behalf for performance under the contract, may provide information about me including, but not limited to, appropriate unique personal identifiers such as date of birth and social security number to other system administrators, Information Security Officers (ISOs), or other authorized staff without further notifying me or obtaining additional written or verbal permission from me.
g. I understand I must comply with VA’s security and data privacy directives and handbooks. I understand that copies of those directives and handbooks can be obtained from the Contracting Officer's Technical Representative (COR). If the contractor believes the policies and guidance provided by the COR is a material unilateral change to the contract, the contractor must elevate such concerns to the Contracting Officer for resolution.
h. I will report suspected or identified information security/privacy incidents to the COTR and to the local ISO or Privacy Officer as appropriate.
2. GENERAL RULES OF BEHAVIOR
a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job.
b. The following rules apply to all VA contractors. I agree to:
(1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract.
(2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions.
(3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract.
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