Performance Work Statement - Isolator Hood Testing and Certification 15 December 2021.docx

Performance Work Statement Service Contract

1.0 GENERAL SCOPE OF WORK

The contractor shall provide a trained Field Service Technician(s) who shall perform periodic Preventive Maintenance, Calibrations and Repairs for the equipment items and equipment requirements listed in this Performance Work Statement under Appendix 1 and Appendix 2 in this Performance Work Statement (PWS). The contractor will provide labor, all supplies, and transportation for technicians to perform the services per the Original Equipment Manufacturer (OEM) specifications, Naval Medical Command P-5132- Equipment Management Manual, local command instructions, and the Joint Commission Hospital Accreditation Program requirements.

The contractor shall allow only fully qualified field engineers and technicians who have gone through OEM Training to perform services on the equipment listed under Appendix 1 of this Performance Work Statement (PWS). Contractors must be registered and certified with the Controlled Environmental Testing Association (CETA) or equivalent guideline prior to performing equipment requirement (compound area) certification as listed in Appendix 2 of this PWS. Certification must be performed in accordance with the guidelines of United States Pharmacopeia 42 (USP-42) National Formulary-37 (NF-37) Chapter 797, Pharmaceutical compounding: Sterile Preparations (Section 5 Certification and Recertification and Section 5.1- Total Airborne Particle Sampling) and chapter 800-Hazardous Drugs- Handling in Healthcare Settings, Section 5 (Facilities and Engineering Controls) and Section 6 (Environmental Quality and Control. If any equipment and equipment requirements is found that is not on the supplied list in Appendix 1 and Appendix 2, Contracting Section must be notified. No work is to be performed on any unit not on the list without a cost estimate and approval in advance.

2.0 DETAILED WORK REQUIREMENTS

The Contractor shall provide the following support:

2.1 Calibration

Provide on-site equipment calibration (including any parts required to compete the calibration) for the equipment listed in Appendix 1 of this PWS. Calibration shall be per the OEM’s specifications or every 6 months. This activity involves the OEM required mechanical and electronic adjustments to ensure consistent, standardized performance or output.

2.2 Preventive Maintenance

The contractor shall provide preventive maintenance (including any parts required to complete the preventive maintenance) for the equipment listed in Appendix 1 of this PWS. Preventive maintenance shall be performed per the OEM specifications, once every 6 months.

2.3 Repairs Not Included (for the purposes of this PWS, calibrations and preventive maintenance are not considered “repairs”) The contractor shall not repair any unit(s) in Appendix 1 of this PWS without the express, written permission of the Contracting Officer. For any repair necessary to return a unit to the OEM specified working condition, the contractor must submit a written breakdown of the problem encountered, the work required to fix the problem, and an estimated price for the repair work, including all parts and labor, to the Biomedical Repair Section points of contact at this email: usn.guam.navhospgu.list.biomed-repair@mail.mil. The Biomedical Repair Section and the Contracting Office will decide whether or not to proceed with the repair work and inform the contractor of this decision. The contractor shall not repair any unit(s) in Appendix 1 of this PWS without the express, written permission of the Contracting Officer.

2.4 Compounding Area Certification

Items listed in Appendix 2: Equipment Requirements (Compounding areas) must be certified using procedures in the current CETA certification guide for Sterile Compounding Facilities or an equivalent guideline. Certification indicates that the compounding area is meeting its design and air quality specifications per table below. Certification of the compounding areas must be performed initially, and recertification must be performed at least every 6 months IAW the USP 42-NF 37 USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations and must include:

· Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The Air changes per hour (ACPH) from Heating Ventilation and Air Conditioning (HVAC), ACPH contributed from the Primary Engineering Control (PEC), and the total ACPH must be documented on the certification report.

· HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

· Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s).

· Total Airborne Particle Sampling: Total Airborne Particle Sampling must be conducted every 6 months to ensure that all engineering control equipment function as designed and that the levels of total airborne particles remain within acceptable limits during compounding in accordance with table below extracted from the USP 42-NF 37 USP General Chapter 797 Pharmaceutical Compounding- Sterile Preparations Section 5 Certification and Recertification and Section 5.1- Total Airborne Particle Sampling.

2.5 Hazardous Drug Sterile Compounding

Items listed in Appendix 2 (1U22B; Pharmacy): Equipment Requirements (Sterile Compounding areas) must be certified using procedures in the current CETA certification guide for Sterile Compounding Facilities or an equivalent guideline. Certification indicates that the compounding area is meeting its design and air quality specifications per table below. Certification of the sterile compounding areas must be performed initially, and recertification must be performed at least every 6 months IAW the USP 42-NF 37 USP General Chapter 800-Hazardous Drugs- Handling in Healthcare Settings.

Certain areas are required to have negative pressure from the surrounding areas to contain HD’s and minimize risk of exposure. Engineering controls are required to protect the preparation from cross-contamination and microbial contamination during all phases of the sterile compounding process. Engineering controls for containment are divided into three categories representing primary, secondary, and supplementary levels of control. Table 3 summarizes the engineering controls required for sterile HD compounding.

· A containment primary engineering control (C-PEC) is a externally ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs.

· The containment secondary engineering control (C-SEC) is the room in which the C-PEC is placed.

· Supplemental engineering controls [e.g., closed-system drug-transfer device (CSTD)] are adjunct controls to offer additional levels of protection.

2.6 Field Service Reports (FSR)

The contractor shall develop and submit to the government an itemized list of all preventive maintenance work, calibration certification and repair work (FSR) upon completion of the service. Reports shall be submitted to this email address: usn.guam.navhospgu.list.biomed-repair@mail.mil.

2.7 Travel and Accommodations

The contractor shall be responsible for all travel and travel related cost (lodging, airfare, per Diem, and transportation) and accommodations shall be arranged by the contractor.

2.8 Recalls

When product recall or upgrades are necessary to maintain the equipment in service within the original manufacture’s specification, the Contractor shall obtain and install equivalent. The Contractor shall schedule with the Biomed Medical Repair Section point of contact for recall services at this email address: usn.guam.navhospgu.list.biomed-repair@mail.mil prior to performing any recall maintenance, to avoid disrupting patient care and to notify the department of arrival, services and maintenance required.

3.0 SPECIAL CONTRACT REQUIREMENTS

3.1 Place of performance:

Work will be performed onsite/ on campus at the following locations:

United States Naval Hospital Guam Pharmacy Department Building 50 Fahrenheit Rd Agana Heights, Guam 96910 Phone: (671) 34-9381

United States Naval Hospital Guam Laboratory Department Building 50 Fahrenheit Rd Agana Heights, Guam 96910 Phone: (671) 34-9381

3.2 Minimum Qualifications:

Only fully qualified field engineers and technicians who have gone thorough original manufacturer (OEM) Training, certified with the CETA and capable of performing compounding area certification in accordance with the guidelines of USP 797 Pharmaceutical Compounding- Sterile Preparations is to be employed in the performance of any and all work performed under this contract.

3.3 Normal Working Hours:

The contractor shall report to the Biomed Shop prior to performing any services at USNMRTC Guam Monday through Friday, between the hours of 0730 to 1630. Specific work schedules will be provided in writing to this email address: usn.guam.navhospgu.list.biomed-repair@mail.mil 30 days prior to any on-site work to be performed.

3.4 Work Attire:

All contractor personnel shall dress in casual business attire when at the work site. Casual business attire excludes short pants, tee shirts, open toe shoes, and other dress considered not to be appropriate. Notwithstanding any other terms or conditions of the contract, contractor wearing inappropriate dress to the work site may be immediately removed from the project, or at the discretion of the USNMRTC Guam. Contractor personnel may be requested by USNMRTC personnel to leave the work site and return with appropriate attire. Travel/lost work time to return with appropriate dress is not chargeable to USNMRTC Guam.

3.5 Communication Courtesy

Contractor personnel shall be courteous and respectful to the customer and all other onsite personnel at all times. The Contractor shall follow the direction provided by USNMRTC Guam management personnel, or their designee(s), regarding the level of communication with the naval base personnel and conflict resolution escalation procedures.

3.6 Contractor Performance Evaluation

If performance does not meet the specifications stated in this PWS the contractor shall be notified of substandard performance. The contractor shall be given a specified amount of time by the Biomedical Repair Section and Contracting Officer to correct the deficiencies. If deficiencies are not corrected, appropriate action will be taken in conformance with laws and regulation.

3.8 Delays

The USNMRTC Guam will review any contractor delay or failure to perform and determine if the delay was caused by technical factors beyond the contractor’s control and without fault or negligence of the contractor. If the review indicates performance deficiency is not the result of factors beyond the contractor’s control, the contractor will be notified by the Biomedical Repair Section and Contracting Officer. The contractor shall respond within 24 hours with receipt of notification, and provide remedies to correct the deficiencies.

4.0 Documentation and Performance

4.1 Service event documentation

Upon completion of each Preventive Maintenance, Calibration or Repair visit the field service technician must submit a FSR for services provided to the biomedical point of contact at this email address: usn.guam.navhospgu.list.biomed-repair@mail.mil within 72 hours of completion. The FSR shall indicate all problems addressed, devices checked, parts replaced or repaired with identification, parts ordered and any issues resolved. Each service report must at minimum document the following data legibly and in complete detail.

REPORTING DETAILS

Will consist of the following information listed below:

· Name of Contractor

· Name of Technician(s).

· Control number for the Contractor or log number for the report

· Description of the work performed in detail

· Equipment identification: Manufacture, model, serial number, electronic control number (ECN)

· Itemized description of services performed with labor and time.

· Action taken and or recommendations for consideration.

· Pending actions or resolutions to any problems.

· Total billing for services provided should be clearly indicated.

· Signature of the field service technician(s) that conducted the maintenance.

USNMRTC Guam shall have unlimited rights to and ownership of all deliverables provided under this Performance Work Statement including all field service reports, equipment recommendations, equipment service briefings, work plans and all other deliverables. The definitions of “unlimited rights” is contained in the Federal Acquisition Regulation (FAR) 27.401, Definitions.

4.2 Formal Acceptance or rejection of Documents

The Government will have 5 business days to review each document and provide feedback/comments. The contractor shall have 5 business days to incorporate any required comments. The contractors’ delivery of the final document to the government shall constitute acceptance by the government.

5.0 PERIOD OF PERFORMANCE

The initial period of performance will be for one year, starting from the day of contract award. The contract will include 4 one-year options.

Preventive Maintenance, Calibrations and Repairs shall be provided every 6 months according to OEM specifications.

Appendix 1. Equipment

Ensure that the original design and functional capabilities will not be changed, modified or altered unless authorized I writing by the manufacturer and the Biomedical Equipment repair section. If any action requires a contractual change to cover expenses, only the contracting officer has the ability to authorize this change. Any contractual changes will be issue in the form of a modification to the contract.

Appendix 2. Equipment Requirements (Compound Areas) Ensure that compound areas be certified in accordance with the guidelines of United States Pharmacopeia 42 (USP-42) and the National Formulary-37 (NF-37) Chapter 797, Pharmaceutical compounding: Sterile Preparations Section 5 and 5.1,and 800-Hazardous Drugs- Handling in Healthcare Settings, Section 5 (Facilities and Engineering Controls) and Section 6 (Environmental Quality and Control. The original design and functional capabilities will not be changed, modified or altered. In the event that the compound areas do not meet required certification requirements, the contractor shall provide any and all issues or concerns found for the equipment requirements listed in Appendix 2 in written form and emailed to this email address: usn.guam.navhospgu.list.biomed-repair@mail.mil with description to be evaluated by the Biomedical Repair section, Pharmacy Department, and Facilities section.

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