36C25019Q0893-003.docx

36C25019Q0893

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. QUOTE 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/QUOTER

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 QUOTE 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. ___________________________________ QUOTE

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR QUOTE 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 QUOTER/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

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25019Q0893 08-15-2019 Brandi Holland 614-257-5537 08-22-2019

3:00PM EST

36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 2780 Airport Drive, Suite 340 Columbus, Ohio 43219 614-257-5537; Brandi.Holland2@va.gov

X

621999 $15 Million

X

N/A

Department of Veterans Affairs

Louis Stokes VA Medical Center 10701 East Boulevard Cleveland OH 44106-1702 36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 Chalmers P. Wylie Putpatient Clinic 420 North James Road Columbus OH 43219-1834

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center P.O. Box 149971 Austin, TX 78714-9971 877-353-9791 512-460-5429

Contractor to provide qualified Intraoperative Neuromonitoring (IONM) Services at the Louis Stokes VA Medical Center located at 10701 East Boulevard, Cleveland, OH 44106.

Reference Schedule of Services and Performance Work Statement on On page 5 through 28.

Addendum to 52.212-1 is listed in this RFQ and Provides instructions to contractor on page 63 through 66.

This acquisition will adhere to the format as defined in FAR Part 12 and will be conducted using the Simplified Acquisition Procedures in FAR Part 13.

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)……………………………………………………..41

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:

Karen Williams, Contracting Officer Department of Veterans Affairs Network Contracting Office (NCO) 10 2780 Airport Drive, Suite 340 Columbus, Ohio 43219 614-257-5220 karen.williams4@va.gov

Brandi Holland, Contract Specialist Department of Veterans Affairs Network Contracting Office (NCO) 10 2780 Airport Drive, Suite 340 Columbus, Ohio 43219 614-257-5537 brandi.holland2@va.gov

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center P.O. Box 149971 Austin, TX 78714-9971

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

The Contracting Officer’s Representative (COR) will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

6. SUBMISSION OF QUOTATION: Documents that are to be provided to the Contracting Officer shall be submitted to the Network Contracting Office, using the appropriate address identified in 52.212-1, Instructions to Quoters. Submit all quotation to both addresses referenced in 1b.

7. SECURE FAX: In accordance with VA Handbook 6500, the following statement is required on all fax cover sheets; if it is determined the ordering process will include a fax: “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.

8. 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.

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

(End of Section B.1)

B.2 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 Louis Stokes Cleveland VA Medical Center (LSCVAMC) in Cleveland, Ohio.

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

Pricing Instructions:

The quoter is instructed to fill in column Unit Price and Estimated Total columns for the base year including all option years and estimated grand total.

Place of Performance: Services shall be provided on-site at the LSCVAMC, 10701 East Blvd, Cleveland, OH 44106.

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.

ALL UNIT COSTS ARE FIRM-FIXED PRICE.

PERIOD OF PERFORMANCE

Notwithstanding this, or any other clause of this contract, the Government is not obligated to exercise any option under this contract. Failure to accept the option year(s) may result in rejection of a quotation.

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

CLIN No.

Services

Unit

Estimated Quantity

Unit Price

Estimated Total

Intraoperative Neuro Monitoring – Technical Services

Each

Intraoperative Neuro Monitoring – Professional Services

Estimated Total Amount Base Year:

OPTION YEAR 1 (CONTRACT YEAR 2): ONE (1) YEAR

CLIN No.

Services

Unit

Estimated Quantity

Intraoperative Neuro Monitoring – Technical Services

Intraoperative Neuro Monitoring – Professional Services

Estimated Total Amount Option Year 1:

OPTION YEAR 2 (CONTRACT YEAR 3): ONE (1) YEAR

Services

Unit

Estimated Quantity

Intraoperative Neuro Monitoring – Technical Services

Intraoperative Neuro Monitoring – Professional Services

Estimated Total Amount Option Year 2

OPTION YEAR 3 (CONTRACT YEAR 4): ONE (1) YEAR

Services

Unit

Estimated Quantity

Intraoperative Neuro Monitoring – Technical Services

Intraoperative Neuro Monitoring – Professional Services

Estimated Total Amount Option Year 3:

OPTION YEAR 4 (CONTRACT YEAR 5): ONE (1) YEAR

Services

Unit

Estimated Quantity

Intraoperative Neuro Monitoring – Technical Services

Intraoperative Neuro Monitoring – Professional Services

Estimated Total Amount Option Year 4:

GRAND TOTAL INCLUDING ALL CONTRACT YEARS:

The Government’s guaranteed minimum during the life of this contract is $4,500.00. The Government’s contract ceiling (contract maximum) amount during the life of this contract is $450,000.00.

B3. PERFORMANCE WORK STATEMENT

INTRAOPERATIVE NEURO MONITORING (IONM)

1. OBJECTIVE

The Department of Veterans Affairs is seeking a contractor to provide qualified Intraoperative Neurophysiologic Monitoring Services and instrumentation at the Louis Stokes Cleveland VA Medical Center, 10701 East Blvd. Cleveland, OH 44106.

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 Neuro 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 Louis Stokes Cleveland VA Medical Center (LSCVAMC) located at 10701 East Blvd. Cleveland, OH 44106.

b. FACILITY: ADMINISTRATIVE HOURS for the VAMC are the following:

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 Luthur 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. 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

· Cranial base tumors

· Posterior fossa tumors

· Microvascular

· Decompression Intracranial Aneurysms

· Fronto-temporal Tumors (motor cortex mapping)

· Temporo-parietal tumors

· Carotid Endarterectomy

· Anterior Cervical

· Diskectomy Anterior

· Corpectomy Anterior Vetebrectomy

· Thoracic laminectomy

· Lumbosacral decompression/stenosis

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

· Stabilization of odontoid/dens fracture

· Intramedullary or extramedullary spinal cord tumors

· Cauda equina tumors

· Spinal cord untethering

· Rhizotomy/ganglionectomy

· Selective dorsal rhizotomy

ii. Orthopedic

· Anterior cervical Diskectomy

· Anterior Corpectomy

· Anterior vetebrectomy

· Cervical laminectomy

· Thoracic laminectomy

· Lumbosacral decompression/stenosis

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

· Stabilization of odontoid/dens fracture

· Scoliosis Correction

iii. Otolaryngologic

· Revision mastoidectomy

· Acoustic neuroma

· Vestibular nerve section

· Cochlear implant

· Glomus tumor

· Parotidectomy

· Thyroidectomy

· Radical head and neck surgery

· Interventional Radiological Procedures

· Occlusion of brain-supplying arteries

· Embolization of cerebral and spinal aneurysms

· Embolizaiton of cerebral and spinal arteriovenous malformations

· Embolizaiton of traumatic cavernous sinus fistula

· Spinal angiography and transvascular thera

· Percutaneous transluminal angioplasty

b. A technician will operate the following systems:

· Caldwell 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. The contractor will provide this equipment.

· 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 and one (1) qualified neurologist to provide interpretation of the information. The Contractor shall appoint one of its personnel to perform administrative and technical duties.

· The services to be performed by the Contractor shall be performed in accordance with LSCVAMC policies and procedures and the regulations of the medical staff bylaws. The LSCVAMC policies and medical staff bylaws will be available upon request. These procedures shall be performed under the direction and to the satisfaction of the LSCVAMC 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.

· 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 LSCVAMC, 10701 East Blvd. Cleveland, OH 44106 in the OR, 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 equivalent for Neurosurgery cases as necessary. Contractor will provide equipment for use in the OR.

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

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.

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 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 produced to the performing surgeon within two hours after the procedure to be placed in the patients electronic medical record.

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).

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. 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.

10. 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.

11. 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.

12. 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.

Page 1 of Page 1 of

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.

13. 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.

d. Cleveland VAMC 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 Cleveland VAMC 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 Cleveland VAMC. 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 Cleveland VAMC 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 Cleveland VAMC 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 Cleveland VAMC policy.

h. The Contractor shall not create or maintain any records containing any non-public Cleveland VAMC 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 Cleveland VAMC 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 Cleveland VAMC 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 Cleveland VAMC-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.

14. BILLING

Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4(g), all invoices must include:

· Name and Address of Contractor

· Invoice Date and Invoice Number

· Contract Number and Purchase/Task Order Number

· Date of Service

· Contract physician(s)

· Hourly Rate

· Quantity of hours worked

· Total price

15. INVOICES

Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

16. 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.

17. Contractor and Personnel Security Requirements:

Contractor’s physicians who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a security investigation and shall receive a favorable adjudication from the VHA Service Center (VSC). In all cases, access (physical and computer) cannot be granted until officially notified by the VSC in Independence, Ambulatory. Access can be granted prior to receiving favorable special agreement check (SAC) adjudication results (e.g. fingerprints). If the investigation is not completed prior to the start date of the contract, the contractor shall be responsible for the action(s) of those individuals they provide to perform work under the contract at and for the CLEVELAND VA MEDICAL CENTER.

18. Position Sensitivity:

Position sensitivity for each contractor’s physicians’ position is determined by the VA through the Position Designation System and Automated Tool (PDAT). Each position will be designated at the high, moderate, or low risk level, depending on the position’s potential for adverse impact to the integrity and efficiency of the services (CFR 731.106). Multiple positions may be documented on a single form. Risk levels determine what level of investigation is required.

19. Personal Identification Verification (PIV):

The contractor’s physicians shall maintain active computer access by logging into a VA computer no less than once every 30 days. To assist contractor’s physicians with maintaining compliance, VPN may be approved on a case-by-case basis.

20. Security Investigation:

The level of background investigation commensurate with the required level of access may be either a Special Agreement Check (SAC), National Agency Check with Written Inquiries (NACI) (low risk), Moderate Background Investigation (MBI) (moderate risk), or Background Investigation (high risk). Non-citizen contractor’s physicians appointed to low risk positions shall be subject to a National Agency Check with Law Enforcement and Credit Check (NACLC). The risk level associated with contractor’s physicians under this contract is: LOW RISK/NACI.

21. Contractor Responsibilities:

The contractor shall prescreen all contractor’s physicians requiring access to the computer systems to ensure they are able to read, write, speak, and understand the English language

Contractor’s physicians shall receive an automated e-QIP invitation, which shall be completed and scanned or faxed to the appropriate individual identified within the automated email request. The two (2) e-QIP signature pages shall be completed and returned within seven (7) days of the request; otherwise, the security investigation shall be terminated and contractor’s physician shall begin the process all over, if the CO warrants this. Contractor’s physicians shall receive e-mail notifications from the VSC explaining specific instructions once an investigation has been received.

The contractor shall submit all security investigation requests to the COR and CO, who will review, sign, and submit the forms to the VSC at the following email mail group: VSCSecurity@va.gov. The security investigation(s) will be assigned to a specific VSC Security Assistant. Once the investigation(s) is assigned for the specific task order number, the VSC Security Assistant handling the investigation will be the responsible individual during the duration of the task order (including all option years associated with it). Then, all new contractor’s physicians will be directly submitted to the VSC Security Assistant.

The level of investigation required is as follows: Low Risk/NACI – VSC Security Request Packet, OF 306, Self-Certification Form, VA0710, and Fingerprints. All forms shall be completed entirely and properly. The continuation form shall only be used if the contractor employee requires extra space.

The contractor’s physicians shall be fingerprinted as part of an investigation. Electronic fingerprinting can be performed at the CLEVELAND VA MEDICAL CENTER VA HR Offices. These stations use electronic fingerprint machines, which require the contractor’s physicians to fill out Form #2 of the VSC Security Request Packet. This form needs to be taken with the contractor’s physicians when getting fingerprinted at a VA Facility Once fingerprinting is complete, VA HR will return the form, which the contractor’s physician needs to submit with the other documentation in the VSC Security Packet and submit to the VSC for review and verification purposes.

When the entire package is complete and received, the VSC Security Assistant will upload the security documentation to the SIC’s SharePoint site for processing. The VSC Security Assistant will validate favorably adjudicated fingerprints. Once confirmed, an email will be sent, granting the contractor employee access to begin providing services at the VA on an interim basis – until the security investigation is in a “scheduled” status at OPM.

Once the contractor’s physician’s security investigation is in a “scheduled” status, the VSC Security Assistant will obtain the va.gov address established for the contractor’s physician and sponsor him/her for a PIV badge. NOTE: PIV Badging for contractor’s physicians shall only be handled and coordinated through Contracting and the VSC.

The Contractor shall, when notified of an unfavorable determination by the Government, withdraw the contractor’s physician from consideration from performing services under the contract.

Failure to comply with the contractor personnel security requirements shall result in termination of the contract for cause.

Upon contract award, the contractor shall furnish the ISO and the CO with a list of contractor’s physicians performing work under the contract. The list shall include a brief description of the work to be performed and degree of access to information management systems required. The description of the required degree of access shall address if remote access is required. The contractor shall update and submit the list of contractor’s physicians performing work on the contract to the ISO every year, throughout the contract period. Furthermore, it shall be the contractor’s responsibility to notify the ISO when contractor’s physicians performing work under this contract no longer require access to information management systems. 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. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

22. Government Responsibilities:

Upon receipt, the VSC will review the completed forms for accuracy, forward the forms to the SIC for processing and issue to OPM to initiate the security investigation.

The VSC and/or the SIC will notify the CO and contractor after adjudicating the results of the security investigations received from OPM, which can take up to six (6) months.

The CO will ensure the contractor provides evidence the investigation(s) have been completed or are in the process of being requested.

Contractor’s physicians performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems belonging to or being used on behalf of the Department of Veterans Affairs. The contractor shall be responsible for the actions of those individuals they provide to perform work for the VA under this contract. In the event damages arise from work performed by contractor providing contractor’s physicians, under the auspices of this contract, the contractor shall be responsible for all resources necessary to remedy the incident. Printed output containing sensitive VHA data shall be stored in a secured area, and disposed of properly by shredding using a NIST-compliant shredder or other VA approved method. Under the provisions of the Privacy Act of 1974 as amended, personnel performing work under this contract have an obligation to protect VA information indefinitely. Furthermore, it is the Contractor’s responsibility to notify the Information Management staff when access to Information Management systems is no longer needed by contractor’s physicians performing work under this contract.

If deemed required under this contract, the contractor shall be considered part of the VA for purposes of 38 U.S.C. §§ 5701 and 7332. Its employees may have access to patient medical records to the extent necessary to perform this contract. Notwithstanding any other provision of this contract, the contractor and contractor’s physicians may disclose patient records and individually-identified patient information, including information and records generated by the contractor in performance of this contract, only pursuant to explicit disclosure authority from VA.

The VA may provide contractor and contractor’s physicians with access to VA automated patient records maintained on VA computer systems only to the extent and under the same conditions and requirements as VA provides access to these records to its own employees.

All contractor’s physicians the VISTA system shall be required to sign and abide by all VA security policies, and applicable VA confidentiality statutes, 38 U.S.C. §5701, 38 U.S.C. §7332, and the Privacy Act, 5 U.S.C. §552a, as well as 45 C.F.R. Parts 160, 162 and 164 (HIPAA). The VA will provide access applications and security agreements. Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality. Due to the confidential nature of medical reports, all transcription shall be completed in areas that provide reasonable security. All documents are confidential and are protected under the Privacy Act of 1974, as amended. All contractor’s physicians shall be required to observe the requirements imposed on sensitive data by law, federal regulations, VA statutes and policy, DM&S policy and the associated requirements to insure appropriate screening of personnel.

If deemed required under this contract the database utilized by the contractor, the adverse drug event reports provided to the contractor by VA, and documents created from analyzing this database, the adverse drug event reports, and patient medical records are medical QA records protected by 38 U.S.C. § 5705, its implementing regulations at 38 U.S.C. §§ 17.500-.511 and VHA Directive 2002-043, Quality Management (QM) And Patient Safety Activities That Can Generate Confidential Documents. These records may be disclosed only as authorized by § 5705 and the VA regulations. Disclosure of these records in violation of § 5705 is a criminal offense under 38 U.S.C. § 5705(e).

If deemed required under this contract, the treatment and administrative patient records created by, or provided to, the contractor under this contract are covered by the VA system of records entitled "Patient Medical Records” - VA (24VA136).

All quality data maintained by the Contractor and/or the contractor’s physicians shall be shared with designated Service Line Staff.

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