Sterilizer_PWS.docx

PERFORMANCE WORK STATEMENT

Johnson & Johnson Medical Sterrad 100NX Plasma Sterilizer

1. BACKGROUND: Requirement is a maintenance contract for the medical equipment listed below. Contractor shall provide on-site remedial maintenance and telephone consultation for the equipment listed in 1.1. Service shall include all travel, labor, parts, manufacture’s authorized field modifications instructions (FMI’s), individual tools and test equipment required to service and maintain the Osan AB owned equipment described in 1.1 IAW MFG specifications and FMI’s.

1.1. EQUIPMENT LIST:

1.2. The contractor shall provide all trained personnel, labor, travel, tools, diagnostic equipment, software, hardware, firmware, materials, supplies, parts and test equipment necessary to maintain the equipment as listed in a fully functional state, in accordance with (IAW) Original Equipment Manufacturer (OEM) specifications.

1.3. The contractor shall provide troubleshooting assistance by telephone, Monday - Friday, 8am-5pm , and/or on-site support as necessary. Additionally, the contractor shall provide and install all hardware and software updates as they become available, with new or updated user manuals. New repair parts must be used to conduct repairs on the equipment. Refurbished parts must meet OEM standards and be pre-approved by the BMET Chief or representative prior to installation. All completed work will be certified to meet OEM specifications.

2. PERSONNEL:

2.1 Minimum Personnel Qualifications: Services under this contract will be performed by individuals who have demonstrated knowledge, and competence in servicing and maintaining the specified equipment under this contract. The Contractor shall insure repair technicians have been fully trained and experienced in testing and repairing the equipment and components on contract. If factory training occurred more than three years ago, proof must be presented that the individual has been actively engaged in repairing the Sterrad 100NX Plasma Sterilizer for 12 months of the last 18 months.

2.2. Personal Appearance: Contractor or his representative(s) performing services under this contract shall practice high standards of personal hygiene and maintain a clean, neat appearance while at the 51 Medical Group or its associated areas.

3. QUALITY ASSURANCE:

3.1. Upon completion of work, an acceptance inspection will be conducted by the Government (personnel from Biomedical Equipment Repair office) and the equipment user to ensure all services were completed. A full service report, in English, will be submitted to the BMET Chief or representative for review. The contractor will include all parts used/replaced and its price. Additionally, the contractor shall include travel and any lodging associated with the service call. The information provided by the contractor will be used by the customer throughout the term of the contract to perform quality assurance and cost analysis before the next option year is exercised.

3.2. Quality Control: The contractor shall ensure that the quality of service and materials provided under this contract meet or exceed the conditions outlined in the PWS.

3.3. Quality Assurance Surveillance Plan (QASP): In accordance with FAR Part 8.406-2 Inspection and acceptance (b) Services, performance will be assessed using a QASP. The QASP specifies how Government quality assurance surveillance of the contract tasks will occur. The QASP will focus on the quality of the contractor performance and not just on the steps taken or procedures used to provide that service. The QASP may include an appropriate use of pre-planned inspections, correspondence reviews, customer surveys, validation of complaints, audits and random unscheduled inspections. The QASP is a form of guarantee that the Government receives the services for which it contracted and pays only for the services it receives. It is the method by which the Government determines if the contractor meets the performance standards in the contract. Contractors will be briefed on surveillance requirements and responsibilities under the QASP at the post award conference prior to contract performance.

4. RESPONSE TIME:

4.1. Routine repairs and technical phone support: five days per week, Monday - Friday, 8am-5pm . The contractor will perform unlimited emergency calls during normal duty hours, five days per week, excluding legal holidays.

4.2. This contract does not cover over-time, after-hours emergencies and federal holiday coverage: All services outside of normal duty hours must be pre-approved repairs by the BMET Chief or representative and will be paid under a separate agreement as needed.

Note: However, if offer includes after-hours emergencies and services at no additional cost to the government (must be the same rate as normal duty hours service) as part of flat quarterly rate, this must be so stated in offer.

4.3. The time frame within which the Contractor must arrive onsite is measured from the time of verbal notification that service is required; response time for this contract will be 48 hours after service call is confirmed. Deficiency will be corrected within 1 duty day when parts are available; if parts cannot be acquired within 1 duty day, the contractor will contact the BMET Chief or representative to communicate the reason for the delay.

4.4. The contractor’s service technician will continue uninterrupted on all services being performed until the system is 100% operational according to the manufacturer’s specifications. In the event a repair is not possible, a like substitute unit will be provided until the inoperative unit is repaired, installed and accepted. Failure to comply with the provisions of this paragraph may be cause for a credit deduction.

4.5. On-site remedial maintenance shall not include parts or service required as a result of any of the following events: Damage from accident, neglect, power surge, power failure or an operating environment not in conformance with the equipment’s published specifications.

5. CONTRACTOR FURNISHED ITEMS: The Contractor shall furnish all materials with original equipment manufacturer parts and labor and supplies necessary to perform the services and repairs; travel will be included in the overall contract cost.

5.1. All replacement parts shall be provided by the contractor. The contractor shall use only new original or factory refurbished replacement parts in the performance of this contract. Replaced parts become the property of the United States and shall be returned to the BMET office. If required replacement parts are not immediately available to the contractor while performing service calls, the contractor shall notify the BMET office of the deficiency, and deliver and install all replacement parts as soon as possible. The contractor shall not remove any item of USAF-owned equipment from the medical facility for service at the contractor’s establishment without the written consent of the BMET Chief or representative. Should it become necessary to remove the equipment from the facility for servicing, the contractor shall provide, at no additional cost to the government, a loaner like item.

6. SECURITY REQUIREMENTS: Contractor personnel or any representative of the contractor entering Osan AB will abide by all security regulations and will be subject to security checks. The contractor or representative will report to the Facility Management service desk to sign-in and receive a temporary access badge; the badge must be returned to Facility Management personnel and the representative must sign out before departing the installation.

7. SPECIFIC TASKS AND DELIVERABLES:

7.1. The contractor, or representative, shall report to the 51st Medical Group BMET office, Ext. 784-2009, prior to commencing all on-site services and repairs during normal operating hours, 7:00 AM to 5:00 PM, Monday through Friday. If services are required after normal duty hours, the staff on site will contact the ER at 784-2500. ER will contact Medical Maintenance on-call tech to receive over-time authorization; contractor will insure service reports, in English, are provided to Medical Maintenance within twenty-four hours of the completed work.

7.2. The contractor shall provide unlimited service calls during specified contract term and must provide advance notice to the BMET Chief or representative of any repairs that exceed the terms of the contract and require additional funding.

7.3. The contractor shall provide all tools, parts and labor required to perform service calls. The service shall include all labor, travel, inspection, and replacement of parts to maintain the government owned equipment and associated components under this contract in a continuous working state.

7.4. The contractor shall furnish and install all manufacturers’ mandatory modifications and apply recalls by FDA and must comply with specified lubrications, cleaning (other than operators), and parts replacement IAW OEM specifications.

7.5. Upon completion of each remedial maintenance visit, the contractor shall provide the BMET with a legible service report in duplicate, in English,. The government representative will countersign the report. Failure to provide a service report will result in delay of payment for service until the service report is received by the government representative. Service reports shall include:

7.5.1. Type of service; i.e. routine, or emergency call.

7.5.2. A description of all services rendered during the visit.

7.5.3. Signature of service person(s) actually performing the repairs.

7.5.4. A list of discrepancies which may still exist for any item on the contract.

7.5.5. A complete list of replacement parts, if used, by part number. Except for exchange parts, replacement parts shall be returned to the BMET at the completion of the required work. The completed service report shall be turned in to the BMET prior to the contractor representative departing the medical facility.

8. NON-COMPLIANCE: In the event the contractor fails to accomplish services within the months specified or within the required repair time frame, the entire agreement will be extended thirty days at no charge to the government.

9. SEEKING ADDITIONAL CHARGES: If the contractor seeks additional charges for corrective work, a firm quote must be provided to, and approved by, the contracting officer or representative before work is accomplished.

10. EQUIPMENT UPDATES: The contractor shall furnish and install all software updates and equipment modifications normally provided by the manufacturer. Updates and modifications shall be furnished at no additional cost under the contract and installed after they are made available by the manufacturer.

11. ALTERNATIVE SERVICES: The contractor shall not use subcontractors in the performance of the contract without written permission of the contracting officer.

12. CREDIT DEDUCTIONS: The contractor is required to maintain all equipment items in this contract in a fully operational condition. Failure to meet the requirements of this contract are subject to credit deductions as follows:

Total number of days unit is non-operational

1) -------------------------------------------------------- = % time equipment non-operations Total number of days of contract

2) % time equipment non-operational X Cost of contract = Basic deduction

3) Basic deduction + Cost of obtaining patient procedures = Total deduction