PWS Vitek 2 Analyzer FY23.docx

PERFORMANCE WORK STATEMENT

U.S. Naval Hospital Guam, Laboratory Department

MAINTENANCE OF VITEK II ANALYZER

I. DESCRIPTION OF SERVICES

The contractor shall provide everything necessary as defined in this Performance Work Statement (PWS), except as specified herein as government furnished property or services, to provide preventive maintenance to include intervening service calls for government owned equipment, located at the U.S.

Naval Hospital Guam Laboratory RM 1T12. The contractor shall perform these services in accordance with the standards specified in this contract and in accordance with the Original Equipment Manufacturer (OEM) Specifications, the National Fire Protection Association Standard NFPA 99 (Electrical Equipment in Healthcare Facilities), the Bureau of Radiological Health (BRH), Health Insurance Portability and Accountability Act (HIPPA) IAW 45CFR 160 and 164, and the Joint Commission for Accreditation of Health Care Organizations (JCAHO). The contractor shall submit reports and documentation as identified throughout this PWS. The contractor shall make available a standard commercial quality control plan upon request by a government representative. Contractor tasks include:

Preventive Maintenance Inspections and calibration services, unscheduled maintenance, and software support.

Service Reports OEM Replacement Parts Unlimited service visit Labor, travel expenses Software feature enhancements and patches 24 hour -Telephone support

1. Preventive Maintenance Inspections and Intervening Repair Service. The contractor shall provide scheduled preventive maintenance inspections on the systems identified in Appendix A, in accordance with OEM specifications. Inspections shall include but are not limited to the following:

Review of system operation.

Calibration of system.

Completion of minor operational and reliability field engineering change notices.

PM to current published OEM specifications.

Contractor shall provide maintenance necessary to preserve image quality, system performance and safety testing. Contractor travel to perform covered service shall be included at no additional cost to the government. Contractor shall arrange the date and time of preventive inspections with the Biomedical Repair Department at least one week in advance. Contractor shall schedule preventive maintenance inspections dates for each system and an annual calibration for the system in conjunction with one PM with the Medical Equipment Repair Center. The Biomedical Equipment Repair may be contacted at 671- 344-9381. All preventive maintenance service shall be accomplished during normal duty hours 8:00 AM to 5:00 PM, Monday through Friday, (excluding Federal Holidays). Emergency service calls will be accomplished during duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal Holidays.

2. Service Reports. A service report is required for any maintenance service performed at any time.

Contractor shall sign in/out on the log sheet and report to the POC in the Medical Equipment Repair Center both upon arrival on-site and upon completion of the work. The original service report, signed off by the department using the equipment, must be presented to the Medical Equipment Repair Center and a copy sent to the Contracting Officer upon completion of the work prior to departure. The service report must include the following as a minimum:

Date and time of service.

Company and service representative names.

Contract number.

A detailed description of any services or repairs performed, documenting labor and any parts used.

Any contractor recommendations necessary to maintain the equipment in the best operating condition.

For PM/Calibration service calls, the PM/Calibration checklist with results will serve as the service report.

Contractor shall ensure compliance with the National Fire Protection Association Standard NFPA 99 (Electrical Equipment in Healthcare Facilities), and shall list electrical leakage current and ground resistance readings for equipment and provide this information as part of the service report.

3. OEM Replacement Parts. Contractor shall provide repair parts meeting or exceeding current OEM specifications. All parts shall be only new standard parts. Replaced parts shall become the property of the contractor and shall be removed from the hospital and disposed of at no additional cost to the government.

4. Modifications/Software Upgrades. All software and hardware modifications and upgrades recommended or normally provided by the OEM to keep the system operational capability current shall be provided and accomplished by the contractor during PM inspections at no additional cost to the government.

5. Priority Mail Shipping of Parts. Cost for additional parts used for repairs and overnight shipping, if applicable, will be added to the invoice.

II. GENERAL INFORMATION

1. Operator Training. Contractor shall provide instructions and training to DGMC equipment operators on the daily, weekly and monthly cleaning and lubrication requirements when required or requested by the MERC.

2. Initial Inspection. All contractors owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact Biomedical Repair to schedule inspection.

3. Removal of Equipment. Should the equipment or any component listed herein require repair at the contractor’s plant, contractor shall obtain a signed authorization from the Biomedical Repair authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement is installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor’s possession.

4. Health Insurance Portability and Accountability Act (HIPAA). In accordance with DoD 6025.18- R “Department of Defense Health Information Privacy Regulation,” January 24, 2003, the Contractor meets the definition of Business Associate. Therefore, a Business Associate Agreement is required to comply with both the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations. This clause serves as that agreement whereby the Contractor agrees to abide by all applicable HIPAA Privacy and Security requirements regarding health information as defined in this clause, and in DoD 6025.18-R and DoD 8580.02-R, as amended. Additional requirements will be addressed when implemented.

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DoD 6025.18-R or DoD 8580.02-R.

Individual has the same meaning as the term “individual” in 45 CFR 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 160.103, limited to the information created or received by the Contractor from or on behalf of the Government pursuant to the Contract.

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.103