36C25619Q0089-001.pdf

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 75

36C25619Q0089 02-01-2019

Stephanie Keo 713-794-8055 02-25-2019

2:00PM CST

36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030 4298

X 100

X

621999

$15 Million

N/A

X

36C580

Department of Veterans Affairs

Michael E. DeBakey VA Medical Center

Receiving Warehouse Building 100

2002 Holcombe Boulevard

Houston TX 77030-4298

36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030 4298

Department of Veterans Affairs

Financial Service Center

PO Box 149971

Austin TX 78714-9971

1-877-353-9791 512-460-5429

See CONTINUATION Page

Contractor to provide qualified Intraoperative

Neurophysiologic Monitoring Services and instrumentation at the Michael E. DeBakey VA Medical Center (MEDVAMC), 2002 Holcombe Boulevard, Houston, TX 77030.

Reference Schedule of Services and Performance Work Statement on page 6 through page 24.

This solicitation is set-aside to Service Disabled Veteran

Owned Small Business (SDVOSB).

Addendum to 52.212-1 is attached and provides instructions to contractor on page 53 through page 55.

See CONTINUATION Page x 1(one)

Stephanie Keo

V1611L2-2173

36C25619Q0089

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE COST SCHEDULE/ SCHEDULE OF SERVICES

B.3 PERFORMANCE WORK STATEMENT (PWS)

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 52.216-18 ORDERING (OCT 1995)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997) . 34

C.9 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.10 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.11 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.12 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)

C.13 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.14 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.15 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(JAN 2008)

C.16 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.17 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) 39

C.18 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO

BENEFICIARIES (JAN 2008)

C.19 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 – QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D.2 – ORGANIZATIONAL CONFLICT OF INTEREST

D.3 – PAST PERFORMANCE WORKSHEET

D.4 - CONTRACTOR RULES OF BEHAVIOR

D.5 – DEPARTMENT OF LABOR WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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

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

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(SEP 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

POC: ___________________________

Address: ________________________

Phone: __________________________

Email: __________________________

DUNS Number: ___________________

TAX ID: _________________________

b. GOVERNMENT:

Stephanie Keo, Contracting Officer (CO) 36C256

Department of Veterans Affairs

Network Contracting Office (NCO) 16

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston TX 77030-4298

Phone: 713-794-8055

Email: stephanie.keo@va.gov

Contracting Officer Representative (COR):

Hayley Raymer, Program Analyst

Department of Veterans Affair

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston, TX 77030-4298

Phone: 713-791-1414 x24145

Email: hayley.raymer@va.gov

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

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

[] 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 mailto:stephanie.keo@va.gov mailto:hayley.raymer@va.gov

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

5. SECURE FAX: Please review VA Handbook 6500 that requires the following statement on all fax cover sheets be included: This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

6. POST AWARD CONFERENCES: The Contracting Officer will schedule a post award orientation conference for contract orientation purposes as required by Information Letter (IL) 003A3-12-04 that provides documentation requirements for orientation conducted for post award conferences.

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

AMENDMENT NO DATE

(End of Section B.1)

B.2 PRICE COST SCHEDULE/ SCHEDULE OF SERVICES

The Contractor shall furnish all personnel to provide Neurophysiologic Monitoring Services (IONM) and instrumentation necessary to perform onsite to eligible beneficiaries of the Department of Veterans

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

The contractor will include operating and maintaining equipment (including monitoring devices), supplies, and labor of on-site qualified technician to perform IONM services.

Pricing Instructions:

The offeror is instructed to fill in column Unit Price and Estimated Total columns for the base year including all ordering period and estimated grand total.

Place of Performance: Services shall be provided on-site at the MEDVAMC, 2002 Holcombe Blvd., Houston, TX 77030.

Period of Performance for base and ordering period is based on a twelve (12) month period, effective date and end date may change depending on when award will be made, but will be based on a twelve (12) month period.

PERIOD OF PERFORMANCE

BASE ORDERING PERIOD: DATE OF AWARD FOR ONE (1) YEAR

CLIN No. Services Unit Estimated

Quantity Unit Price

Estimated

Total

Intraoperative Nerve

Monitoring – Technical

Services

Each 120

Intraoperative Nerve

Monitoring – Professional

Estimated Total Amount Base Year: ____________________________

ORDERING PERIOD 1: ONE (1) YEAR

CLIN No. Services Unit Estimated

Quantity Unit Price

Estimated

Total

Intraoperative Nerve

Estimated Total Amount Period 1: ____________________

ORDERING PERIOD 2: ONE (1) YEAR

CLIN No. Services Unit Estimated

Quantity Unit Price

Estimated

Total

Intraoperative Nerve

Estimated Total Amount Period 2: ____________________

ORDERING PERIOD 3: ONE (1) YEAR

CLIN No. Services Unit Estimated

Quantity Unit Price

Estimated

Total

Intraoperative Nerve

Estimated Total Amount Period 3: ____________________

ORDERING PERIOD 4: ONE (1) YEAR

CLIN No. Services Unit Estimated

Quantity Unit Price

Estimated

Total

Intraoperative Nerve

Estimated Total Amount Period 4: ____________________

ESTIMATED GRAND TOTAL INCLUDING ALL ORDERING PERIODS: __________________

The Government’s guaranteed minimum during the life of this contract is $2,400.00. The Government’s contract ceiling amount during the life of this contract is $2,000,000.00.

NOTE: The rates in effect under the contract in accordance with FAR Clause 52.217-8 Option to Extend

Services, will be the rates that apply to the previous ordering period before exercising the six (6) month extension.

(End of Section B.2)

B.3 PERFORMANCE WORK STATEMENT (PWS)

INTRAOPERATIVE NERVE MONITORING (IONM)

1. OBJECTIVE

The Department of Veterans Affairs is seeking a contractor to provide qualified Intraoperative

Neurophysiologic Monitoring Services and instrumentation at the Michael E. DeBakey VA Medical

Center in Houston, 2002 Holcombe Blvd, Houston, Texas 77030.

Neurophysiologic monitoring is the use of electrophysiological methods such as electroencephalography

(EEG), electromyography (EMG), and evoked potentials to monitor the functional integrity of certain neural structures (e.g., nerves, spinal cord and parts of the brain) during surgery. The purpose of

Intraoperative Nerve Monitoring (IONM) is to reduce the risk to the patient of iatrogenic damage to the nervous system, and/or to provide functional guidance to the surgeon and anesthesiologist.

The contractor shall provide complete neurological monitoring services to include operating and maintaining equipment (including monitoring devices), supplies, and labor of on-site qualified technician to perform IONM services.

2. AGENCY BACKGROUND

a. PLACE OF PERFORMANCE:

The Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, Texas 77030.

b. FACILITY ADMINISTRATIVE HOURS

Hours for the VAMC follow:

1. Administrative Hours: Monday through Friday, 8:00am to 4:30pm Local Time

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

New Years Day;

Martin Luther King’s Birthday;

Presidents 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.

3. SCOPE

a. SERVICES REQUIRED: Specifically, the contractor shall provide electrophysiological monitoring of patients to assess the functional integrity of the peripheral or central nervous system in the operating room or other acute care setting.

This will primarily happen during neurosurgery cases or for any case where the surgeon feels like the patient’s central and/or peripheral nervous system is at risk. The technical component of monitoring services shall be performed by surgical neuromonitorists who record electrical activity from the brain, spinal cord, peripheral nerves, somatosensory, or motor nerve systems using a variety of techniques and instruments. The professional interpretation of monitoring services shall be performed by a qualified professional.

b. The contractor shall provide the services of a(n) intraoperative neurophysiologic technician(s) and required instrumentation to monitor the following surgical procedures but not limited to:

i. Neurosurgical

1. Cranial base tumors

2. Posterior fossa tumors

3. Microvascular

4. Decompression Intracranial Aneurysms

5. Fronto-temporal Tumors (motor cortex mapping)

6. Temporo-parietal tumors

7. Carotid Endarterectomy

8. Anterior Cervical

9. Diskectomy Anterior

10. Corpectomy Anterior Vetebrectomy

11. Thoracic laminectomy

12. Lumbosacral decompression/stenosis

13. Instrumentation for spinal instability (to include pedicle and lateral mass screws)

14. Stabilization of odontoid/dens fracture

15. Intramedullary or extramedullary spinal cord tumors

16. Cauda equina tumors

17. Spinal cord untethering

18. Rhizotomy/ganglionectomy

19. Selective dorsal rhizotomy

ii. Orthopedic

1. Anterior cervical Diskectomy

2. Anterior Corpectomy

3. Anterior vetebrectomy

4. Cervical laminectomy

5. Thoracic laminectomy

6. Lumbosacral decompression/stenosis

7. Instrumentation for spinal instability (to include pedicle and lateral mass screws)

8. Stabilization of odontoid/dens fracture

9. Scoliosis Correction

iii. Cardiothoracic

1. Carotid Endarterectomy

2. Carotid body tumor

3. Subclavian-carotid bypass

4. Extra cranial vascular reconstruction

iv. Otolaryngologic

1. Revision mastoidectomy

2. Acoustic neuroma

3. Vestibular nerve section

4. Cochlear implant

5. Glomus tumor

6. Parotidectomy

7. Thyroidectomy

8. Radical head and neck surgery

v. Interventional Radiological Procedures

1. Occlusion of brain-supplying arteries

2. Embolization of cerebral and spinal aneurysms

3. Embolizaiton of cerebral and spinal arteriovenous malformations

4. Embolizaiton of traumatic cavernous sinus fistula

5. Spinal angiography and transvascular thera

6. Percutaneous transluminal angioplasty

c. A technician will operate the following systems:

i. Cadwell Cascade Monitor System or equivalent equipment which includes only FDA approved hardware: Base Unit, Pro/Cascade Amplifier with Meter Cable, Recording

Extender Pods, Pro/Cascade ES Stimulator, Auditory Electrode Kit, Transcranial

Stimulator, Insert Earphone, Windows 7 Professional Laptop (Dell, Toshiba, or similar), one Cart. Modalities: Free run EMG, Stimulated EMG, SSEP, EEG, ABR, MCM, PR, and TcMEP with multimodality, interleave and trending capabilities.

d. In most instances, the Contractor will be contacted at a minimum of 48 hours to reserve technician for scheduled case. Coverage will include one (1) technician to assist for each procedure requiring the use of the Cadwell Cascade Monitor System or equivalent equipment. The Contractor shall appoint one of its personnel to perform administrative and technical duties.

e. The services to be performed by the Contractor shall be performed in accordance with

MEDVAMC policies and procedures and the regulations of the medical staff bylaws. The

MEDVAMC policies and medical staff bylaws will be available upon request. These procedures shall be performed under the direction and to the satisfaction of the

MEDVAMC Chief of Staff or his/her designee. The contractor will provide technicians to do real time monitoring of neurophysiological responses in the operating room and this will be transmitted to an offsite location to be viewed by Neurologist who can provide feedback to the operating team. The contract neurologist is not required to be in the OR.

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

4. GENERAL REQUIREMENTS

a. General:

i. Timeliness: Arrive on site at the MEDVAMC, 2002 Holcombe Blvd, Houston, TX

77030 in the OR, room 5A-269, Building 110 at least 60 minutes prior to surgery time.

ii. Know the general condition of the patient and the factors that affect planning for the operation prior to the operation. By communicating to the resident or surgeon 15 minutes prior to the surgery.

iii. Ensure aseptic technique is used at all times in the OR Suite.

b. Routine:

i. Assemble vendor owned and operated, Cadewell Cascade Monitor System or equivalent for Neurosurgery and/or ENT cases as necessary. Vendor will provide equipment for use in the OR.

ii. Maintain cleanliness and order at all times needed for cases at MEDVAMC.

iii. Prepare and calibrate equipment prior to the procedure to ensure equipment is functioning properly.

iv. Operate Cadwell Cascade Monitor System or equivalent equipment while surgery is being performed to ensure smooth functioning.

v. Clean and reassemble all equipment after each case. (per MEDVAMC Policy

118CPO-010 Cleaning and Disinfection of Non-Critical Reusable Patient Care

Equipment (PCE))

c. Periodic:

i. Prepare and operate Cadwell Cascade Monitor System or equivalent and all associated equipment (every day of surgery).

ii. Calibrate Cadewell Cascade Monitor System or equivalent (every day of surgery).

iii. Report Contract Administration complications (as necessary). Respond to scheduling of urgent cases (per contract and as needed) within 8 to 12 hours. This will only occur in rare occasions.

d. Occasional: Urgent cases that consist of return to hospital to support other urgent

Neurosurgery and ENT operations within 8-12 hour notice. A technician and offsite MD interpreter must be available. Again, In the past year there have been only rare occasions of urgent cases.

e. Perform patient safety measures to include:

i. Positive identification of the patient prior to services being rendered by checking at least two (2) identifiers. Specifically, the Contractor shall check the name and other identifying data and compare these with the information recorded within the

Computerized Patient Record System (CPRS). Examples of acceptable identifiers include but are not limited to: patient name, date of birth, social security number, etc.

ii. Clinical monitoring of the patient, based on vital signs and baseline assessments.

iii. Ensuring completion of services related to all aspects of the Cadwell Cascade

Monitor System, including initial assessment, initial education, and patient monitoring and management.

f. REPORTS: A formal report must be faxed to the performing surgeon within two days.; a formal original copy must be mailed to the performing surgeon within two weeks.

5. QUALIFICATIONS

a. The technical component of monitoring services shall be performed by qualified surgical

Neuromonitorists and the professional interpretation of monitoring services shall be performed by a qualified MD professional with appropriate licenses and no pending government actions.

Readings occur off-site. On site technician (s) must be a certified to provide intra-operative monitoring. Monitoring includes EMG, SSEP, BAER. The technician provides the equipment to provide internet transmission of live-time monitoring to a board-certified physician, to assess the monitoring and provide intra-operative interpretation of data. Readings occur off-site.

b. Physicians shall possess the following minimum qualifications:

i. Graduation from a medical school approved by the Liaison Committee on Medical

Education of the American Medical Association or the American Osteopathic

Association or permanent certification by the Educational Commission for Foreign

Medical Graduates (ECFMG).

ii. Board certification in Neurology.

iii. Possess a current, unrestricted license to practice medicine in any one of the fifty

States, the District of Columbia, the Commonwealth of Puerto Rico, Guam or the U.S.

Virgin Islands.

iv. Must have professional knowledge of a wide range of monitoring concepts, principles, practices, and methods to perform highly specialized monitoring assignments of advanced nature and considerable complexity such as somatosensory evoked potentials, auditory brainstem and cortical responses, electroencephalography, visual evoked responses, facial nerve monitoring, motor evoked potentials, intraoperative electromyography, intraoperative nerve conduction velocity, etc., requiring extensive specialized training and experience in order to determine the methods/procedures required during the surgical procedures, prepare the patient, interpret the data, provide recommendations to the surgeon, and train other professional/technical personnel.

c. Assigned contract personnel must have a minimum of two (2) years work experience operating the Cadwell Cascade Monitor System or equivalent. In addition, the Contractor shall submit evidence that the personnel assigned to work this contract routinely perform intraoperative monitoring services at another medical institution on days not outlined in this contract.

d. Contractor shall not have personnel report to duty until written notification is received from the Contracting Officer or designee (e.g. COR) advising that the candidate(s) presented has met all requirements for contract performance.

e. REQUIRED MEDICAL CERTIFICATION: All on-site contract employees may be required to obtain "Medical Screening". All employees may be required to obtain physicals, latex screening, immunization records (including TB). Medical screening forms shall be provided at time of award (where required).

f. INSURANCE: Since this is a non-personnel service contract - the contractor is required to have their own insurance. 4.1. The Contractor shall maintain during the term of this contract medical liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence: $1,000,000. 4.2. Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

6. RECORD KEEPING

a. For services performed at the VAMC, the following shall apply:

i. The VAMC shall establish and maintain a record keeping system that will record the hours worked and services performed by the Contractor’s employee(s) to ensure that required services have been received by the VAMC.

ii. Contractor’s employee(s) shall report to the VA Surgery Service COR or designee upon initial arrival at the VAMC.

b. Documentation of services performed shall be reviewed prior to certifying payment. The

VAMC shall pay for services actually performed and in strict accordance with the price schedule and statement of work. Contract monitoring and record-keeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided.

7. CONTRACT PERFORMANCE MONITORING

a. For services performed at the VAMC, monitoring of Contractor employee(s) time shall be demonstrated through sign-in/ sign-out sheets (hard copy or electronic). Contractor employee(s) shall be required to sign an attendance log upon reporting to work and departing from work. The

COR shall be the VAMC official responsible for monitoring contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

8. QUALITY ASSURANCE SURVEILLANCE

a. This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

i. What will be monitored?

ii. How monitoring will take place?

iii. Who will conduct the monitoring?

iv. How monitoring efforts and results will be documented?

b. This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

c. This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and

Government officials implementing surveillance activities.

d. The COR shall also receive a time and attendance report that lists each day of the month, the time they spend at the VA facility and a brief description of activities.

e. The COR may perform surveillance of services by:

i. Observing actual performance;

ii. Checking time and attendance logs;

iii. Checking OR records;

iv. Reviewing minutes of meetings;

v. Inspecting the services to determine whether or not the performance meets the performance standards; and

vi. Review of any other appropriate electronic records.

vii. Review of interpretations submitted in a timely manner.

f. As part of the surveillance plan, the COR shall review all invoices for accuracy prior to payment.

g. In all cases, surveillance shall not be so intrusive as to impact the Contractor’s successful accomplishment of the mission.

h. When unacceptable performance occurs, the COR shall inform the Contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the

COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report

(CDR), and present it to the contractor's program manager. The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor's corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

i. Quality assurance monitoring documentation shall become an official Government record of the Contractor’s performance.

j. The VAMC shall establish and maintain a record keeping system that will monitor the performance of the contract provider(s). This shall be accomplished utilizing this Quality

Assurance Surveillance Plan (QASP)/Checklist.

9. APPROVAL OF CONTRACTOR PERSONNEL

a. The MEDVAMC reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor shall employee or subcontractor shall employee who, by reason of previous unsatisfactory performance at the VA or for any other valid reason, is considered by the Contracting Officer to be objectionable, as long as 30 days written notification of unsatisfactory performance has been provided to the Contractor; and the problem has not been cured in the 30 day period.

10. SUBCONTRACTING

a. Any subcontractor utilized by the Contractor for the provision of services required under this contract shall meet the same qualifications specified herein for the Contractor. The Contractor shall obtain approval from the Contracting Officer for any subcontractor to be utilized for the provision of services required under this contract.

11. PROTECTED HEALTH INFORMATION (PHI)

a. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and

Security of Protected Health Information.

12. PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL

a. All personnel employed by the Contractor shall comply with Homeland Security Presidential

Directive 12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24 and

Federal Information Processing Standards Publication (FIPS PUB) Number 201, which requires all federal employees, Contractor and affiliates to have a Personal Identity Verification (PIV) identification card. The PIV process shall be initiated and completed by the VA. The Contractor shall be responsible for all costs associated with transportation of the employee to the VA to initiate the fingerprinting and overall process. The COR will ensure all Stealth Navigators are informed of procedures for obtaining proper Identification cards.

13. CONTRACTOR SHALL CERTIFICATION (IMMIGRATION)

a. The Contractor shall comply with all applicable immigration laws, rules and regulations, including the Immigration and Nationality Act of 1952, as amended and shall prior to performance under this Contract execute the Contractor shall Certification incorporated herein.

14. KEY PERSONNEL

a. The Contractor shall assign to this contract the following key personnel:

List of key personnel who will be performing services under this contract. This is required for purposes of background investigations.

b. During the first ninety (90) days of this contract, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by the individual’s illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within five (5) calendar days after the occurrence of any of these events.

c. The contractor shall provide a telephone number to provide point of contact for VAMC staff.

The contractor staff assigned to answer this telephone shall act as the initial point of contact for inquiries from appropriate VAMC personnel.

d. 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 Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. Any substitute personnel must be credentialed and privileged by VA in accordance with the provisions of VHA Handbook 1100.19.

The contract shall be modified to reflect any approved changes of key personnel.

e. For temporary substitutions where the key person shall not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

15. RECORDS MANAGEMENT

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR

Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of

44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

Proposed Technologist/MD

Name

Tile

d. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The

Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

h. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

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

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

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

16. INVOICES

Contractor shall provide statements/invoices to the MEDVAMC within 30 days of end of each month services delivered. Statements/Invoices shall include patient last name and last four digits of the social security number to whom neurological monitoring services were administered, unit price and total cost for services provided.

17. BACKGROUND CHECKS

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 Office of Security and Law Enforcement 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 will be responsible for the actions of those individuals they provide to perform work for VA.

18. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with

VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive

Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a

Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security

Clearance must be processed through the Special Security Officer located in the Planning and

National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S.

to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure

VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media

Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business

Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

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

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

6. 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.

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach.