RFQ 36C25625Q0129 - IONM Houston.pdf
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- Solicitation number
- 36C25625Q0129
About this file
This is a Request for Quotation (RFQ) issued by the Department of Veterans Affairs Network Contracting Office 16 for Intraoperative Neurophysiologic Monitoring (IONM) Services at the Michael E. DeBakey VA Medical Center in Houston, Texas. The RFQ (36C25625Q0129) is a 100% Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside with a size standard of $20.5 million under NAICS code 621999.
The contractor must provide qualified IONM technicians, equipment, and instrumentation to monitor neurological function during surgeries including neurosurgical, orthopedic, cardiothoracic, and otolaryngologic procedures. The period of performance includes a base year (April 1, 2025 - March 31, 2026) and four ordering periods. Quotes are due by January 22, 2024 at 3:00 PM CST. The contract has a minimum value of $1,000 and maximum of $5,000,000. Key requirements include providing Cadwell Cascade Monitor System or equivalent equipment, arriving 60 minutes before surgery, and submitting formal reports within two days. The contractor must provide monitoring for an estimated 230 procedures per year. Technical capability, past performance, and price will be evaluated to determine the best value offer. Offerors must be VetCert certified at time of quote submission and award.
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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. UEI: EFT:
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. NOV 2021)
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
36C25625Q0129 01-04-2024
Stephanie Keo 713-791-1414 01-22-2024
15:00 CST
36C256
Department of Veterans Affairs
Network Contracting Office 16
5075 Westheimer Road, Suite 750
Houston TX 77056-5643
X 100
X
621999
$20.5 Million
N/A
36C580
Department of Veterans Affairs
Michael E. DeBakey VA Medical Center
Receiving Warehouse Building 100
2002 Holcombe Boulevard
Houston TX 77030-4298
36C256
Department of Veterans Affairs
Network Contracting Office 16
5075 Westheimer Road, Suite 750
Houston TX 77056-5643
FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp
Invoice Setup Information 1-877-489-6135
Invoice must be submitted electronically
1-877-489-6135 512-460-5429
See CONTINUATION Page
Contractor to provide complete qualified Intraoperative
Neurophysiologic Monitoring Services and instrumentation at the Michael E. DeBakey VA Medical Center, 2002 Holcomb
Boulevard, Boulevard Houston, TX 77030. See Price/Cost Schedule of
Services and Performance Work Statement (PWS) for details.
NOTIFICATION TO OFFERORS: Required documents and instruction are on page 55 through page 58 - INSTRUCTIONS TO OFFERORS
This is a Service-Disabled Veteran Owned Small Business
(SDVOSB)set aside. Offerors must be VetCert certified at time of quote submission and at time of award.
See CONTINUATION Page
Stephanie Keo
VA-VHA-RPOC-2023-0081
36C25625Q0129
Table of Contents
SECTION A
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
B.3 PERFORMANCE WORK STATEMENT (PWS)
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS
AND COMMERCIAL SERVICES (NOV 2023)
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
C.3 52.216-18 ORDERING (AUG 2020)
C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)
C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)
C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)
C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS
C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 36
C.9 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA
BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)
C.10 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-
DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)
C.11 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—
CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)
(DEVIATION)
C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV
2018)
C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)
C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT
STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (MAY 2024)
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS
D.1 ATTACHMENT 1: QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
D.2 ATTACHMENT 2 – WAGE DETERMINATION
D.3 ATTACHMENT 3: VAAR 852.219-75
SUBCONTRACTING – CERTIFICATE OF COMPLIANCE FOR SERVICES AND
CONSTRUCTION (JAN 2023)
(DEVIATION)
D.4 ATTACHMENT 4: CONTRACTOR CERTIFICATION IMMIGRATION AND
NATIONALITY ACT
D.5 ATTACHMENT 5: KEY PERSONNEL
D.5 ATTACHMENT 6: PAST PERFORMANCE REFERENCES
SECTION E - SOLICITATION PROVISIONS
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (SEP 2023)
ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL
PRODUCTS AND COMMERCIAL SERVICES
ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB
1998)
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS
AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)
E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—
REPRESENTATION AND DISCLOSURES (DEC 2023)
E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)
E.6 52.216-1 TYPE OF CONTRACT (APR 1984)
E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)
E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL
PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)
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: ___________________________
SAM UEI Number: ____________________
TAX ID: __________________________
b. GOVERNMENT:
Stephanie Keo, Contracting Officer (CO)
Department of Veterans Affairs
Network Contracting Office 16 (NCO 16)
5075 Westheimer Road, Suite 750 (90C)
Houston, TX 77056
Email: stephanie.keo@va.gov
Thomas Hewett, Contracting Officer Representative (COR)
Department of Veterans Affairs
Michael E. DeBakey VA Medical Center
2002 Holcombe Boulevard
Houston, TX 77030
Email: thomas.hewett@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, or
[] 52.232-36, Payment by Third Party
3. INVOICES: Invoices shall be submitted in arrears:
a. Quarterly []
b. Semi-Annually []
c. Other [x] Monthly in arrears
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment 5.
INVOICING/BILLING: Contractor shall establish a recordkeeping system of contractor services mailto:stephanie.keo@va.gov mailto:thomas.hewett@va.gov provided. Contractor may only bill for actual hours worked on-site at Michael E. DeBakey VA Medical
Center locations. At the end of each month the contractor will submit an invoice for payment.
6. INVOICE REQUIREMENTS AND SUPPORTING DOCUMENTATION: Reference Performance
Work Statement under Billing for additional information.
7. SECURE FAX: 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.”
8. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by VA Acquisition Manual, Part M842.502-70.
9. EMPLOYMENT REPORTS ON SPECIAL DISABLED VETERANS OF THE VIETNAM ERA,
AND OTHER ELIGIBLE VETERANS (VETS 4212): Offerors in accordance with FAR clause 52.222-
37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans, which is incorporated in this solicitation by reference, and Public Law 105-359, section 1354
(enacted October 31, 1998), the successful offeror must meet the reporting requirement as required by the clause. The contracting officer may require the successful offeror to furnish evidence that it has complied with requirements to file a VETS-4212 Federal Contractor Report (formerly VETS-100) with the
Department of Labor for the preceding fiscal year (30 SEP) until Title 38 Section 4212(d) (weblink http://www.dol.gov/vets/vets4212.htm). For questions and information on filing VETS-4212 reports, contract the VETS-4212 Processing Center at (866) 237-0275 or visit the Department of Labor’s web site at http://www.dol.gov/vets/contractor/main.htm. and/or for further assistance or questions VETS4212-customersupport@dol.gov.
10. SYSTEM AWARDS MANAGEMENT SYSTEM (SAM): Federal Acquisition Regulations require all contractors conducting business with the Government be registered in the System Awards
Management System (SAM) online database for the provision of basic information relative to contract awards (see FAR Clause 52.212-4(t)). This may be accomplished at http://www.sam.gov. It is the responsibility of the contractor to renew this registration annually.
11. E-VERIFY: The contractor in accordance with FAR clause 52.222-54, Employment Eligibility
Verification are required to enroll in and use the Department of Homeland Security (DHS), United States
Citizenship and Immigration Services’ (USCIS) electronic employment eligibility verification program
(E-Verify). The Federal government has a long-standing policy to only contract with businesses and other entities that abide by the immigration laws of the United States and to employ only individuals who are authorized to work. E-Verify is the best means to electronically confirm identity and employment authorization of employees working under covered Federal contracts, as required by clause 52.222-54.
USCIS has enhanced the E-Verify website with resource information and outreach materials to assist with enrollment and use of eVerify. USCIS routinely hosts free public webinars on E-Verify and has a detailed
E-Verify.
mailto:VETS4212-customersupport@dol.gov mailto:VETS4212-customersupport@dol.gov http://www.sam.gov/
12. SERVICE CONTRACT REPORTING: In accordance with FAR 52.204-15, Service Contract
Reporting Requirements for Indefinite-Delivery Contracts, the contractor is required to report the total amount invoiced and the direct labor hours expended on the services performed under this contract. The information is collected through the System for Award Management (SAM) and included in the agency’s service contract inventory. Contractors are encouraged to review this information and to make note of reporting dates and deliverables to ensure their compliance with the law and regulation. Refer to FAR
4.1703 for thresholds. Indefinite-delivery contracts reporting requirements, which will be based on the expected dollar amount and type of the orders issued under the contracts. FAR 4.1703. See FAR 4.17 -
Service Contracts Inventory. Guidance for contractors is in the “Service Contract Reporting” clause of their contract (52-204-14 or 52.204-15), and in SAM’s Quick Start Guide for Service Contract Reporting, and SAM’s Full User Guides, available at www.SAM.gov under the “Help” tab.
13. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
AMENDMENT NO DATE
(End of B.1 Contract Administration Data) http://www.sam.gov/
B.2 PRICE/COST SCHEDULE
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.
ITEM INFORMATION
ITEM
NUMBER
DESCRIPTION OF
SUPPLIES/SERVICES
ESTIMATED
QUANTITY UNIT UNIT PRICE AMOUNT
230 EA __________________ __________________
Intraoperative Nerve Monitoring - Technical Services
Contract Period: Base Year
POP Begin: 04-01-2025
POP End: 03-31-2026
PRINCIPAL NAICS CODE: 621999 - All Other Miscellaneous
Ambulatory Health Care Services
PRODUCT/SERVICE CODE: Q510 - Medical - Neurology
Intraoperative Nerve Monitoring - Professional Services
Contract Period: Base Year
POP Begin: 04-01-2025
POP End: 03-31-2026
Contract Period: Ordering Period 1
POP Begin: 04-01-2026
POP End: 03-31-2027
Contract Period: Ordering Period 1
POP Begin: 04-01-2026
POP End: 03-31-2027
Contract Period: Ordering Period 2
POP Begin: 04-01-2027
POP End: 03-31-2028
Contract Period: Ordering Period 2
POP Begin: 04-01-2027
POP End: 03-31-2028
Contract Period: Ordering Period 3
POP Begin: 04-01-2028
POP End: 03-31-2029
Contract Period: Ordering Period 3
POP Begin: 04-01-2028
POP End: 03-31-2029
Contract Period: Ordering Period 4
POP Begin: 04-01-2029
POP End: 03-31-2030
Contract Period: Option 4
POP Begin: 04-01-2029
POP End: 03-31-2030
ESTIMATED
GRAND TOTAL
Base Year: $________________
Ordering Period Year 1: $________________
Ordering Period Year 2: $________________
Ordering Period Year 3: $________________
Ordering Period Year 4: $________________
Grand Total Estimated Price to Include (Base plus 4 Ordering Periods): $___________________
Estimated Quantities: All quantities listed herein are estimated annual quantities. The Government is not obligated to purchase any specified amount of services under this contract but will be obligated to make payment for all services requested and received in the quantities and of the quality requested. The
Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contract.
Minimum/Maximum Contract Amounts: In accordance with FAR 16.504, Indefinite Quantity Contracts, the guaranteed minimum of services the Government will acquire under this contract is Minimum
$1,000.00 and the Maximum $5,000,000.00.
NOTE: For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause.
Ordering Procedures:
a. This contract type allows the Department of Veteran Affairs Network Contracting Office 16
(NCO 16) contracting officers to place orders with the contractor on an as needed basis, in accordance with the FAR Clauses 52.216-18, Ordering. NCO 16 will obligate the funding and order the services by issuing a task order. The estimated number of hours for performance of each task order shall be set forth in each task order.
b. The contractor shall initiate work when so directed by a task order. No work under any task order shall be performed unless specifically authorized by the contracting officer. Approval of a task order shall not constitute approval to exceed any item listed in the contract or general provisions of the contract. The contractor shall not exceed the task order amount or change the task order without prior written approval of the Contracting Officer.
c. Task orders within scope of the IDIQ contract will be issued unilaterally in accordance with the
IDIQ Contract terms and conditions and bilaterally when change in terms and conditions is negotiated in accordance with contract clauses FAR 52.212-4(c), FAR 52.216-18, FAR 52.216-19 and FAR 52.216-22.
d. Task order pricing for services will be based on IDIQ prices based on negotiated priced contract line items as outlined in B.2 Price/Cost Schedule section in this single award IDIQ contract.
e. Contractor is required to deliver services in accordance with the task order terms and conditions during the task order specified period of performance.
f. The NCO 16 Contracting Officer is the only authorized official to issue task orders under this
IDIQ Contract.
g. Task order prices shall be Fixed-Price (FP) as agreed to in the contractor’s schedule and individually funded.
Each task order shall have an established period of performance or delivery date. Individual task order shall not exceed a 12-month period.
(End of Section B.2 Price/Cost Schedule)
B.3 PERFORMANCE WORK STATEMENT (PWS)
INTRAOPERATIVE NERVE MONITORING (IONM)- HOUSTON, TX
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 Boulevard, 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 or VAMC) located at 2002
Holcombe Boulevard, 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 11 holidays observed by the Federal Government are:
New Years Day;
Martin Luther King’s Birthday;
Presidents Day;
Memorial Day;
Juneteenth National Independence 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 or equivalent equipment, 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 performance work statement. 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.
k. A copy of the QASP is outlined in Section D.1 Attachment 1.
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. See Section D.5 Attachment 5 for list of key personnel. This is required for purposes of background investigations. The contract shall be modified to reflect any approved changes of key personnel.
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.
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.
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