S02- Atch_Draft_SOW Integra Cusa Clarity.pdf

Cusa Clarity ANNUAL MAINTENANCE SOW

a) EQUIPMENT IDENTIFICATION

Equipment Internal Asset Number Serial Number

Integra Cusa Clarity 1766804 CHG1700901IE

The Integra Cusa Clarity includes: one (1) console, two (2) handpieces and one (1) cart.

b) GENERAL REQUIREMENT

I. Michael E. Debakey Medical Center (MEDVAMC) is requesting for a contractor to provide preventive maintenance and service on the Integra Cusa Clarity ultrasonic tissue ablation equipment at the MEDVAMC located at 2002 Holcombe Blvd, Houston, TX 77030. The full clinic listing of the equipment can be found in the Equipment Identification section.

II. The Contractor shall provide all, firmware & software, installation, parts, labor, calibration and preventive maintenance inspections per the OEM recommendations and guidelines to fulfill this contract. The Contractor shall provide calibration and preventive maintenance services by OEM-authorized service providers of the equipment listed in the Equipment Identification section. The calibration procedure shall consist of calibrating the entire instrument to traceable calibration standards. The instrument shall be cleaned. Worn or defective parts shall be replaced when necessary, as per manufacturer’s specifications. Service also includes all necessary intervening service calls required to replace any worn or defective part needed due to instrument failure.

III. Preventive maintenance shall be performed yearly.

c) DEFINITIONS/ACRONYMS I. Biomedical Engineer(ing) - Supervisor or designee.

II. CO - Contracting Officer III. COR - Contracting Officer's Representative IV. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

V. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

VI. ESR – Contractor’s Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

VII. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

VIII. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

IX. MEDVAMC – Michael E. Debakey Veterans Affairs Medical Center X. NFPA - National Fire Protection Association.

XI. CDRH - Center for Devices and Radiological Health.

XII. VAMC - Department of Veterans Affairs Medical Center

XIII. VAH - Department of Veterans Affairs Hospital XIV. OEM - Original Equipment Manufacture

d) CONFORMANCE STANDARDS I. Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by the VAMC as well as following most current published standards/ specifications/regulations:

II. Manufacturer’s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL) ,Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

e) HOURS OF COVERAGE

I. Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding holidays. All service/repairs shall be performed during normal hours of coverage unless requested or approved by COR or his designee.

II. Technical support via phone shall be available twenty-four (24) hours a day, seven (7) days a week.

III. Any necessary hardware/software update/upgrade installations as deemed by the OEM shall be scheduled at least three (3) days in advance and shall be performed at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the

COR).

IV. Work performed outside the scope of this contract at the request of COR or designee shall be billed at the price listed in contractor’s contract. Billing shall include service time and exclude parts, unless the parts are replacements have exceeded replacement limits, as they are included in this contract. The COR or designee shall provide a credit card purchase order to cover charges outside of the scope of this contract. PO# must be included on invoice for payment.

V. Federal Holidays observed by the VAMC are:

1. New Years' Day

2. Martin Luther King Day

3. Presidents' Day

4. Memorial Day

5. Independence Day

6. Labor Day

7. Columbus Day

8. Veterans' Day

9. Thanksgiving Day

10. Christmas Day

VI. In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Federal Statute

2. Any other day designated by Executive Order

3. Any other day designated by the President’s Proclamation

f) UNSCHEDULED MAINTENANCE (Emergency Repair Service)

I. Contractor shall maintain the equipment in accordance with the manufacturer's latest specifications. The Contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished unless parts replacement limits have been exceeded.

II. The CO, COR or designee has the authority to approve/request a service call from the Contractor.

III. Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE shall commence work (on-site physical response) within twenty-four (24) hours and shall proceed progressively to completion without undue delay. This requirement for response time shall be the same for both services calls during the VA normal business hours and after-hour service calls. Corrective work shall be completed within forty-eight (48) hours from telephone contact time or a loaner must be delivered at the request of the COR.

IV. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete unscheduled maintenance is included within this contract unless specifically stated in writing otherwise and approved by the COR.

V. Contractor shall provide mandatory safety and performance-related updates to covered equipment and software.

VI. The Contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment, if applicable.

VII. The Contractor shall replace up to two (2) handpieces damaged by customer misuse or abuse or those in service for fifty (50) hours at no additional charge. The MEDVAMC shall return any handpiece being replaced under this contract within one week of receiving the handpiece replacement. Should no handpieces need replacing due to misuse or damage or timed usage during the contract term, the Contractor shall provide two (2) new handpieces at the contract term end date. The Contractor shall provide an unlimited number of handpiece replacements for those handpieces which fail to work properly due to manufacturing defects. All replacement handpieces shall be shipped by the Contractor within 24 hours of customer-initiated notification.

g) SCHEDULED MAINTENANCE

i. The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. Preventive maintenance inspections shall be scheduled by the Contracting Officer Representative (COR) or the MEDVAMC Biomedical Engineering designee. The PM must be done in accordance with the latest OEM maintenance procedures and protocols. (An outline of the PM procedures and schedule shall be provided to the COR). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR at the completion of the PM or within 5 business days. The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

1. Cleaning of equipment.

2. 18-point OEM standardized visual inspection.

3. 54-point OEM standardized automated performance check including but not limited to:

speaker function, temperature sensor function, pinch value function, fan function, back-up battery life, fuse life, drive voltage, power output, aspiration function, ultrasonic output, irrigation motor speed, irrigation flow rate, footswitch connection, footswitch output, replacement of the lithium coin battery, replacement of the dart controller, replacement of grounding finger contact, and electrical safety testing.

4. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications.

5. Calibrating and lubricating the equipment.

6. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

7. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

8. Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to mounting hardware, support devices, cables, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

9. Performing remedial maintenance of non-emergent nature and returning the equipment to the operating condition defined in "Conformance Standards" Section.

10. Providing documentation of services performed.

ii. PM services shall be performed in accordance with, and during the hours defined in the "Hours of

Coverage" section and the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

iii. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR.

h) PARTS

I. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or service for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No re-manufactures or gray market items shall be acceptable.

II. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Contractor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA facility upon discovery of such items.

III. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications.

Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).

IV. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records.

i) SERVICE MANUALS/TOOLS/EQUIPMENT

I. The VAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the COR upon request.

II. Should the COR request it, prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

j) CONTACT INFORMATION

Upon contract award, the Contractor must provide valid and reliable contact information for service, preventative maintenance, emergency and technical assistance requests.

k) REPORTING REQUIREMENTS

I. The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature" unless otherwise stated by the COR. If the COR is unavailable, a signed, authorized copy of the ESR shall be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

1. VA Biomedical Contact Persons:

2. Location (Building/Room Number):

3. Telephone Number & Extension(s):

II. Contractor ‘s repairman shall complete a full-service report, in writing, after each service call (emergency or scheduled) and submit either a hard copy or an electronic version of this report to the COR within 5 days after the service day.

l) DOCUMENTATION/REPORTS

I. The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the "Conformance Standards" section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The electronic engineering service report (ESR) shall consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

i. Name of contractor and contract number.

ii. Name of FSE who performed services.

iii. Contractor service ESR number/log number.

iv. Date, time (starting and ending), equipment downtime and hours on-site for service call.

v. VA purchase order numbers covering the call if outside normal working hours.

vi. Description of problem reported by COR.

vii. Identification of equipment to be serviced:

a. Inventory ID number,

b. Manufacturer's name,

c. Device name,

d. Model number,

e. Serial number,

f. Any other manufacturer's identification numbers.

viii. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

a. Labor and Travel,

b. Parts (with part numbers),

c. Materials and Circuit Location of problem/corrective action.

ix. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage).

x. Signatures:

a. FSE performing services described.

b. Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR before service is completed!

m) REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

n) ADDITIONAL CHARGES

I. There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

II. In any case, the VA shall be explicitly notified in advance that additional charges shall be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform service, a separate purchase order shall be issued to the Contractor for the work. Any service required which the Contractor believes to be in excess of the contract provisions and require additional payment (e.g., work beyond normal work hours) shall not be performed without prior authorization from the BIOMED COR, who shall arrange a separate purchase order to pay for the additional service if desired by the VA.

III. The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc., on straight time or overtime work.

o) CONDITION OF EQUIPMENT

The Contractor accepts responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the Contractor from performance of the requirements of this contract.

p) REMOVAL OF EQUIPMENT

Should a piece of equipment require repair at the Contractor ‘s plant, the Contractor shall coordinate with the COR or the MEDVAMC Biomedical Engineering designee the removal of equipment.

Government property cannot be removed from the station, when Contractor-initiated, without a signed Property Pass. This Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

q) COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

I. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who shall serve as the backup.

II. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized OEM-training program, for the equipment and is OEM Certified. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on Integra Cusa Clarity. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC prior to award. The COR may authenticate the training requirements, request locations, training certificates or credentials, and technician location from the Contractor at any time for any personnel who are servicing or installing any equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment if evidence is not provided when requested.

III. If subcontractor(s) are used, they must be approved by the COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

r) SAFETY REQUIREMENTS

I. In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer or his/her designee shall notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed enough for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

II. The VAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence.

s) INSURANCE

I. Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.

II. General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

III. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.

t) PAYMENT

I. Invoices shall be paid in arrears on a regular basis. Invoices, MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period of service.

II. All invoices shall be submitted in arrears, properly prepared in accordance with FAR 52.212-4, contain enough details, and match with the service tickets for the work rendered.

III. Invoices for fixed fee shall be properly prepared and sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. Invoices shall be sent in arrears at the beginning of the first month of each quarter following the quarter in which the services were rendered and billed for. At a minimum, all invoices shall include the following details:

1. Description of the services rendered

2. Billing period in which the services were rendered

3. Correct purchase order number which shall be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor.

4. Invoice number and date IV. Payments shall be made in accordance with the prompt payment act out of the Government annual appropriated funds obligated in a purchase order which shall be issued after the contract is awarded.

u) GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT

After the contract has been in force for a period, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

v) END OF SERVICE PERIOD

I. No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer.

II. Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date to the COR.

w) PRIVACY/SECURITY

The contractor shall not have electronic connectivity to the VA network. Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO should removal from the device be necessary. Electronic or magnetic data storage devices are not to be removed from VA property.

(End of Statement of Work)