PWS Surgical Instrument Repair Maint FINAL.docx

PERFORMANCE WORK STATEMENT

SURGICAL INSTRUMENTS REPAIR AND MAINTENANCE

TRIPLER ARMY MEDICAL CENTER, HONOLULU, HAWAII

TABLE OF CONTENTS

1. INTRODUCTION.

1.1 This requirement is for an annual maintenance service contract for the Government owned surgical instruments, to include all labor, parts, material and travel, to repair and /or maintain the Government owned surgical instruments, in a fully functional condition in accordance with (IAW) Original Equipment Manufacturers (OEM) specifications. Services shall include sharpening, adjusting, polishing, cleaning, remove rust, spots, and stains, realignment and replacement of parts that are lost, worn, or broken to like–new condition on Government-owned general and specialized surgical instruments for Sterile Processing Department (SPD), Tripler Army Medical Center (TAMC), Hawaii.

1.2 This contract is a non-personal services contract which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

1.3. The surgical instruments are located at Tripler Army Medical Center (TAMC), , Hawaii.

2. ADMINISTRATIVE INFORMATION.

2.1 Hours of Operation. Tripler Army Medical Center, HI provides services 24 hours a day, 365 days a year (366 days during leap years) including holidays.

2.1.1 Normal business hours for the Sterile Processing Department (SPD) are 0700 – 1600, Monday – Friday. Clinics have designated operating hours.

2.1.2 The contractor shall make every practical effort to provide services during normal business hours, excluding Federal holidays. However, in certain cases, permission may be granted to the contractor to provide services outside of normal operating hours if during these hours (1) access to the equipment being serviced is limited or unavailable, (2) servicing the equipment would cause impactful impedance to patient care, or (3) the contractor provides any other justified reasoning for unavailability that is accepted by the Medical Maintenance NCOIC. Approval to perform services outside of normal business hours will be given by the COR.

2.1.3 TAMC Medical Maintenance provides emergency services after-hours by means of an on-call technician. In the event any contractor is performing services outside normal business hours, the on-call technician will be available to perform duties of TAMC Medical Maintenance (i.e. periodically checking on the progress of contractor personnel to ensure the security of the hospital, verifying the quality of services rendered meets or exceeds the standards set forth in the PWS, and assist the contractor personnel in signing out in SPD with badge return).

2.1.4 This contract is NOT a time and materials effort. It is not to be billed hourly and does not cover over-time, after-hours emergencies or Federal holiday coverage.

2.1.5 Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday. Any holidays falling on a Sunday will be observed the following Monday.

New Year’s Day, January 1st Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Independent Day, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

NOTE: Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2.2. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award. Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

2.3. The Contracting Officer’s Representative (COR) will be the KO’s authorized representative in administering the contract at the MTF level. The Contractor’s representative shall be available to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

2.4 Combatting Human Trafficking. Combating Trafficking in persons (awareness program) shall be 100% compliance (zero tolerance) regarding trafficking in persons policy in accordance with FAR 52.222-50 and FAR 22.1703.

3. SCOPE OF WORK.

3.1 Equipment to be Serviced.

3.1.1. Current updated list of inventory surgical sets is included in Appendix A (Attachment 1). The estimated volume of instruments to be serviced is 10,100 instruments/quarter.

3.2 Specific Tasks and Deliverables. The contractor, or contractor representative, shall report to the COR/Government Representative or on-site Equipment Maintenance Coordinator (EMC) (room G1B500 and telephone (808) 433-5161), prior to commencing all services and/or repairs).

3.2.1 All service visits shall be coordinated between the contractor, the Medical Maintenance Technician requesting service, and the COR/Government Representative.

3.2.2 Any deliverables (i.e. replacement parts, supplies, tools) shall be shipped to Medical Maintenance at the address below and will be provided to the contractor upon initial check-in at the Medical Maintenance front desk.

Tripler Army Medical Center 1 Jarrett White RD ATTN: MCHK-DS, Sterile Processing Department, RM 2G219 Honolulu, HI 96859-5000

3.3 General Work Requirements. The contractor shall provide trained personnel for support, to include labor, travel, tools, hardware, firmware, materials, supplies, parts and test, measurement, & diagnostic equipment (TMDE) necessary to perform all operations in connection with scheduled preventative maintenance (PM) and/or calibration (CAL) procedures as well as unscheduled repair visits as needed in order to maintain the listed equipment and/or its components if any, in a fully functional state, in accordance with (IAW) the Original Equipment Manufacturer (OEM) specifications. Any software updates provided by the OEM for covered equipment that enhances equipment functions and operations without hardware changes shall be installed. All equipment must be in compliance with Joint Commission (JC), HIPAA and the NFPA 99 Standard for Health Care Facilities.

3.3.1 The contractor shall perform off-site repair, modification, fabrication of surgical instruments and/or necessary replacement parts as needed on Government owned general, specialized including delicate surgical instruments to include: sharpening, adjusting, polishing, cleaning, removing rust, spots, and stains, realignment and replacement of parts that are lost, worn, or broken to like–new condition, straightening, modifying, restoring, re-grooving, refurbishing, insulating, color-coding, silver/stainless welding, silver/stainless soldering, inserting gold handles and replacing of screws, pins, nuts, bolts, caps, locks and spring.

3.4 If applicable, the contractor shall adhere to all DHA cyber security measures when accessing the equipment remotely. The contractor shall not remotely access the equipment from locations outside of the United States. The contractor shall ensure that all appropriate approvals are granted prior to accessing the network and that a service report is generated and delivered to the COR/Government Representative once completed.

3.5 Response Time. The time frame, within which the contractor’s representative must respond, is measured from the time of verbal notification that service is required. Acceptable response times are as follows; (1) Contractor shall acknowledge receipt of notification of service call request within two hours. (2) Contractor shall arrive on-site within twenty-four hours and have a 48-hour turn around for maintenance and repairs to include rust and stain removal. (3) Instances of failed contractor equipment shall be reported to the COR and EMC within 4 hours. If parts cannot be acquired within the first eight hours from first notification, the contractor shall contact the COR and EMC to communicate the reason for the delay. The cause of the failed equipment shall be corrected within a period of five days from first notification. The Contractor’s service technician shall provide a report that includes, at a minimum, the explanation for any maintenance delays and the estimated time to complete the repair to the COR 5 days after first notification.

3.6 Uptime. Uptime is defined as the time during which a piece of equipment is functioning or able to function. The contractor shall provide services to repair and/or maintain the equipment listed above, and components if any, to a fully functional condition with a ninety-eight percent (98%) uptime guarantee (calculated on quarterly basis).

3.7 REPAIRS (Unscheduled Services).

Upon request by the COR/Government Representative, the contractor shall perform unscheduled services to repair the equipment and associated components to a fully functional condition. The contractor shall remain in compliance of the response time parameters set forth in the PWS as stated in 3.5.

3.7.1 All repair parts, whether new or refurbished, shall meet OEM standards, in order to be used to conduct repairs on the equipment. If new parts are not available, refurbished parts may be used, but must be pre-approved by the Medical Maintenance NCOIC prior to installation. All completed work shall be certified to meet OEM specifications.

3.7.2 All parts supplied shall be compatible with the existing instruments.

3.7.3 The contractor shall have ready access to unique and/or high mortality replacement parts.

3.7.4 The contractor shall provide for all replacements of worn or defective parts (excluding consumables) necessary to restore the equipment to 100% operational condition as specified by the OEM.

3.7.5 All replacement parts shall become the property of the government and the replaced malfunctioning part shall become the property of the contractor.

3.7.6 Freight, postage and storage charges associated with shipment, receipt of replacement parts and the return of worn or defective parts shall be the responsibility of the contractor.

3.7.7 In any event the contractor is found to have used replacement parts considered by the OEM to be substandard, any resulting costs and liability will be the obligation and responsibility of the contractor. In the event of any such circumstance, the Contracting Officer will make the final determination about whether a replacement part is of equal or better quality.

3.8 Upon Completion of Service Calls.

3.8.1. Upon completion of work, the technical POC shall provide verification to the EMC that the work performed is acceptable to the Government to meet manufacturer’s specifications.

3.8.2 After performing Calibration/Verification/Certification (CVC) services, the contractor’s representative shall affix a DD Form 2163 (Medical Equipment Verification/Certification) label IAW instruction provided in (1) TB 38-750-2, (2) SB 8-75-11, and (3) TB MED 750-1.

3.8.2.1 Required forms and extracts from pertinent directives will be furnished to the contractor’s service representative by the government upon request.

3.8.3 The contractor personnel shall sign out at the Medical Maintenance front desk personnel where they signed in upon arrival (Room G1B500).

3.8.4 The contractor shall submit a full Field Service Report (FSR) to the COR/Government Representative for review within 72 hours of completion of services. The FSR may be submitted in person upon completion, via mail (address stated in PWS 3.2.2), fax (808-433-4415), or email (dha.tripler.Tripler-amc.mbx.ld-emb-mm-contract@health.mil).

3.8.4.1 The Field Service Report shall provide a detailed account of the service call to include the initial fault or cause for service call, a detailed account of services performed and corrective action taken, labor cost information (hours and labor rate), and TMDE used (serial numbers where applicable and calibration dates). The contractor shall include all parts used/replaced and its price. The information provided by the contractor shall be used by the customer and/or the COR quarterly throughout the term of the contract to perform quality assurance and cost analysis.

3.9. Licensure/Certification/Qualifications

3.9.1. The contractor shall have a minimum liability insurance of $1,000,000 in order to perform this type of service.

3.9.2. Experience: Services under this contract shall be performed by individuals who have demonstrated knowledge, and competence in servicing and maintaining the specified equipment under this contract. The Contractor shall ensure repair technicians have been fully trained and experienced in testing and repairing the equipment and components on contract. The chosen representative(s) by the contractor shall have a minimum one (1) year of experience in maintaining the equipment specified in this PWS. List any OEM training certificates required if applicable.

3.9.2. Contract personnel shall comply with MTF policies regarding personal appearance and conduct.

3.9.3 Compliance. The Contractor and contract personnel shall abide by all MTF standards, rules and procedurals. Such regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives. The contractor shall ensure all personnel performing services under this contract shall be informed of the guidelines and contractual requirements set forth in the PWS and contract, including but not limited to, all safety/security protocol and credential verification procedures.

3.10. OPSEC.

3.10.1.

AT Level I training. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

3.10.2. Access and general protection/security policy and procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.10.3. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

3.10.4. iWATCH/Suspicious Activity Reporting Training. The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

3.10.5. Per DHA-AI 5200.03, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter

3.10.6. Threat Awareness Reporting Program. For all contractors with security clearances. Per DHA-AI 097, Insider Threat Program, contractor employees must receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based.

4. QUALITY MANAGEMENT

4.1 The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

4.2. The Contractor shall ensure that all contract employees comply with the MTF quality management/process improvement activities.

4.3 Performance Requirements Summary (Attachment 2)

4.3.1 The inspection and acceptance point for all services rendered under this contract will be the COR. The performance by the contract personnel, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the KO or COR. The Quality Assurance Surveillance Plan (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.

5. SAFETY / SECURITY REQUIREMENTS

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

5.1.1 When required, the contractor’s service representative shall comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on equipment.

5.2 Hazardous Items. The government and the contractor’s service representative shall exchange hazard communication information (i.e. MSDS, etc.) before the commencement of any service for the safety of all parties.

5.3 MTF Security. Contractor personnel and/or any representative of the contractor entering the MTF shall abide by all security regulations and be subject to security checks. The contractor and/or his representative shall report to the Medical Maintenance Work Order desk (room G1B500) to sign-in and receive a temporary access badge; the badge shall be returned to the front desk clerk and the representative shall sign out before departing the installation.

5.4 Network Security Requirements. When applicable, the contractor shall abide by all procedures and regulations set forth by Information Management Division (IMD), Tripler Army Medical Center, HI to include remote access to the network.

5.4.1 If applicable, the contractor shall be granted an Interim Authority to Operate (IATO) of six months to meet MTF minimum security requirements. These include:

5.4.2 The contractor shall use the MTF’s approved method of connection for vendors requiring remote access capabilities for support of their applications / systems. The contractor shall coordinate with Information Management Division (IMD), Information Systems Engineering (ISE) Branch to meet current technical requirements for a VPN connection.

5.4.3 RESERVED

5.4.4 The contractor shall identify employees requiring an MTF network account for remote connectivity and shall submit (DOD) DD Form 2875 System Authorization Access Request (SAAR) for those employees supporting the application remotely.

5.4.5 The contractor shall ensure a Security Background Investigation has been initiated by the contracting organization. Security Background Investigations are required for all network users. The MTF uses Standard Form 85P - Questionnaire for Public Trust Positions. This can be accessed at the link below. Once at the website, click on SF Form 85P.

http://www.opm.gov/forms/standard-forms/

Note: Foreign Nationals will not be granted access to the MTF network until a satisfactory Security Background Investigation has been completed and they have been approved for access by the Designated Approving Authority (DAA) / Commanding General.

5.4.6 The contractor shall complete all IA training requirements as outlined by the Authorized User Policy (AUP). DOD and DHA have mandated IA training be completed initially and then annually for anyone accessing a DOD network. The contractor shall submit a 'Certificate of Training' from the DISA DoD IA Awareness Training.

5.4.7 The contractor shall read and sign the Acceptable Use Policy (AUP). TAMC Form 835 - Acceptable Use Policy (Dated 19 June 2008) is required initially and then required to be signed annually for all network users. The contractor shall sign the AUP initially and annually thereafter or at time of contract renewal, whichever is earlier. TAMC Form 835 Acceptable Use Policy should be provided to the Vendor by the System Administrator assigned to the application/system.

6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

Following is a list of basic publications applicable to this performance based statement of work. The Contractor is obligated to follow these publications.

Applicable Publications

Public Law:

Public Law 91-596 Occupational Safety and Health Act of 1970 Public Law 104-191 Health Insurance Portability and Accountability Act of 1996

Accreditation Manuals:

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System www.health.mil/Reference-Center/DHA-publications

Department of Defense (DoD):

DoDD 8500.01E Information Assurance

7.0. ACRONYMS AND DEFINITIONS.

8.0 LIST OF ATTACHMENTS

Attachment 1 – Appendix A Current Inventory Attachment 2 - Performance Requirements Summary

END OF PERFORMANCE WORK STATEMENT