Draft SOW REES 4.25.2020.pdf

Statement of Work – Environmental Monitoring

PART 1

1.1 GENERAL INFORMATION

The National Institutes of Health Clinical Center (NIH CC) Pharmacy Department requires continuous monitoring of medication storage conditions and environmental conditions within the following pharmacy facilities: inpatient areas, outpatient areas, Non-Sterile compounding and sterile compounding suites for both Hazardous and non-hazardous activities, expanded intravenous admixture unit, pharmacy designated storage units, analytical unit and the clinical pharmacokinetic research laboratory. Monitoring includes room temperature, room humidity, refrigeration temperature, freezer temperature, incubator temperatures and differential pressure.

This Statement of Work (SOW) issued by National Institute of Health, Clinical Center describes the goals expected to be achieved with regard to executing the maintenance (PM Service) and 3 point calibrations twice a year of all probes (currently 203 probes (Points)) on up to four different nodes in the Clinical

Center.

1.2 Background:

The Clinical Center at the NIH in Bethesda, Maryland, is the nation’s largest hospital devoted to clinical research. It is a national resource that makes it possible to rapidly translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease.

The CC Pharmacy consists of inpatient and outpatient pharmacy sections. The inpatient section is further divided into Unit Dose (UD) and Intravenous Admixture Unit (IVAU). The inpatient pharmacy is open 24 hours a day, seven days a week. The IVAU is responsible for the compounding of sterile injectable preparations. Regulatory standards and requirements for environmental monitoring include all areas that medications are kept or stored and facilities that aseptically prepare sterile products.

1.3 Current Environment:

The Pharmacy Department’s primary operating objective is to support and conduct research by providing quality patient care through demonstrable control, storage and maintenance of medications.

The Clinical Center Pharmacy currently utilizes REES Centron SQL monitoring system. Rees

Scientific Corporation is the original equipment manufacturer and provides technical support, maintenance and calibration services for the system. Preventive Maintenance Service and 3 point calibrations are required twice a year of all probes (currently 203 probes (Points)) that are on three different nodes as mentioned below, with a fourth node planned.

Node #1 - 60 points

Node #2 - 81 points

Node #3 - 62 points

Node #4 -TBD

Inputs/points or probes may be added to any of the above four nodes and the calibration must occur on any probes that are requested and in use at the time of request.

In order to properly install, modify, service, validate, update and maintain the system REES

Scientific Corporation must use proprietary hardware and REES Scientific technicians. REES

Scientific Corporation does not sell or provide parts, software, or validation protocols to any outside vendors or distributors.

1.4 Objective:

The National Institutes of Health (NIH), Clinical Center Pharmacy Department must procure

Brand Name or Equal Environmental Monitoring System with Preventive Maintenance.

Contractor shall properly install, modify, service, validate, update and maintain the system, provide PM and 3 point calibration of all the probes on four different Nodes in the Pharmacy.

1.5 Scope of Work

The contractor shall identify the necessary hardware and system modifications necessary to achieve the stated objective and provide the applicable services identified.

The scope of the Pharmacy REES Monitoring system will apply to the following components of

Pharmacy Department

1.5.1 The Contractor shall be responsible for coordination and planning of design requirements as it relates to REES data/power needs.

1.5.2 The contractor shall be responsible for the installing, training, testing and continuous maintenance support of the system.

1.5.3 The solution provided must be capable of maintaining monitoring of existing inputs without interruption.

1.5.4 The Option to add nodes and probes must be available.

1.5.5 Training of pharmacy staff.

1.5.6 Onsite implementation and support.

1.5.7 The contractor shall provide a solution that will interface and is compatible with the current pharmacy system. Contractor shall provide patch within 24 hours for any server/system upgrades that take place at the NIH

1.5.8 The contractor will provide an onsite technician Monday through Friday, including federal holidays, to provide prompt servicing, probe replacement, and system analysis as requested by the Pharmacy Department. Contractor will provide on call, onsite services for service requests that occur outside of the normal weekday business hours of 8:00am-4:30pm.

These on call services will also be available on weekends and federal holidays.

1.6 Contract Type and Period of Performance

A single Firm Fixed Price type contract is contemplated for one 12-month base period and four

12-month option periods to extend the effective period of performance. Options to increase quantities may be exercised by formal modification to the contract should there be a need to provide additional equipment as the Pharmacy Department Area expands. The base period will include new equipment installation, existing equipment modification/relocation, system configuration and testing. Maintenance, service, technical support and calibration will be maintained throughout

The Period of Performance is estimated to begin in June, 2020 and run through June, 2025.

Estimated Periods of Performance is as follows.

Base Period: 6/11/2020 – 6/10/2021

Option Period One (1): 6/11/2022 – 6/10/2023

Option Period Two (2): 6/11/2023 – 6/10/2024

Option Period Three (3): 6/11/2024 – 6/10/2025

Option Period Four (4): 6/11/2024 – 6/10/2025

1.7 Recognized Holidays: Work may occur on Federal Holidays. Maintenance Support may occur all hours and across all days.

The ten holidays observed by the Federal Government are as follows:

New Year’s Day Memorial Day Columbus Day Christmas Day

Martin Luther King Day

Independence Day Veterans Day

President's Day Labor Day Thanksgiving Day

Also, any other day declared by the President of the United States to be a National or Federal holiday.

1.8 Hours of Operation: The NIH CC operates 365 days per year, 24 hours per day including all holidays. Maintenance Support must be provided across all days and hours (365x24x7).

1.9 Installation Timing: The Contractor will work with Pharmacy Department personnel to schedule and perform the installation of any new probes as needed. Installation will be performed at the convenience of the location receiving the system. Installation may occur

Monday through Sunday, including holidays and any day declared an official Federal Holiday.

1.10 Place of Performance: The work to be performed under this contract will be performed at the NIH Clinical Center Pharmacy Department, 9000 Rockville Pike, Building 10, Bethesda, MD 20892.

1.11 Security Requirements: Contractor personnel performing work under this contract must have a NIH CC Contractor badge which will require fingerprinting and a background check.

a. Physical Security: The Contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

b. Key Control: The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the NIH CC

Contracting Officer.

1. In the event keys, other than master keys, are lost or duplicated, the

Contractor shall, upon direction of the NIH CC Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

2. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the NIH CC Contracting Officer.

1.12 Special Qualifications: The Contractor must ensure that all staff maintain his/her NIH badge which requires completion of annual training (i.e., security, privacy).

1.13 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The NIH CC Contracting

Officer, NIH CC Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance.

At these meetings, the NIH CC Contracting Officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the

Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.14 NIH CC Contracting Officer's Representative (COR): The NIH CC COR is a specialist from the NIH CC Pharmacy Department whose role is to define, plan, track and manage the project.

The following individual is designated as the NIH CC COR:

Project Officer

Name: Rick DeCederfelt

Address: 10 Center Drive, Building #10, Room 1C240. Bethesda, MD 20850

Email: RdeCederfe@cc.nih.gov

Phone Number: 301-402-7091

1.15 Executive Management Oversight: Executive Management oversight for this project is provided by the NIH CC Chief Pharmacy and the NIH CIO.

1.16 Identification of Contractor Employees: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Badges must be worn at all times.

1.17 Data Rights: The Government has unlimited rights to all documents/materials produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the

Government with all rights and privileges of ownership/copyright belonging exclusively to the

Government. These documents and materials may not be used or sold by the contractor without written permission from the NIH CC Contracting Officer. All materials supplied to the

Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.18 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the NIH CC Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the NIH CC Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the NIH CC Contracting Officer and in the event the NIH CC

Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the NIH CC Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.19 Phase out Period: To reduce any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board for 60 days prior to the contract phase out period. During the phase out period, the Contractor shall transfer any system knowledge to the Government.

PART 2 – MINIMUM REQUIREMENTS

2.1 The Contractor shall provide an environmental monitoring system that meets the objectives stated in this statement of work. Solution will maintain all the current systems inputs and any new added as required by the Department of Pharmacy on all 4 Nodes.

- Written notification when probes are identified as not working.

- Completed repairs within 24 hours of initial notification.

2.1.1 The contractor is responsible for the automatic renewal and scheduling of 6 monthly 3 point calibration certification. Bi-annual calibration to be coordinated and scheduled by contractor for all equipment (Fridge, freezer, etc.) and devices (differential pressure, temperature, humidity probes)

2.1.2 Calibration Reports should include but not limited to: Location, Sensor (Manufacturer, model #, serial #, Calibration Due Date, Next Cal Date, Accuracy, Span), Test Instrument(

Manufacturer, model #, serial #, Calibration Due Date, Next Cal Date), Point, As found (Slope, intercept, reference instrument value, sensor value deviation) As Left(Slope, intercept, reference instrument value, sensor value deviation). Results of pass fail criteria. Signed off by

Technician.

2.2 Probes shall be indicated for wet installation locations that can resist exposure to surface disinfectants.

2.3 Calibration of particulate matter is not required but evidence that system responds to particulate challenge is required.

2.4 Differential pressures must be read using a certified manometer and documented.

2.5 Copies of reference equipment calibration certificates.

2.6 Onsite refresher training at each preventive maintenance visit.

2.7 Upgrading of software as upgrades become available.

2.8 Identify and conduct preventative maintenance for panels and equipment (Checklist should be provided. Checklist should include refill of glycol etc.)

2.9 The System shall be capable of documenting the measurements of all probes for an indefinite amount of time.

2.11 The contractor must provide 24/7 technical support.

2.12 The contractor must provide 24/7 onsite support in the event of emergency maintenance as needed for outlined inputs and nodes.

2.12.1 An emergency is deemed as any event in which pharmacy is unable to resolve.

Additionally, it requires specialized equipment to test or remediate the emergency.

2.12.2 Technician should be onsite and provide a diagnosis within 1 hour.

2.12.3 Technician should be able to remediate or repair the damaged probe, input, node, etc. within 4 hours unless the necessary equipment is not readily available. Equipment that must be ordered must be onsite and replaced within 24 hours.

2.13 The contractor must provide copies of reference equipment and calibration certificates.

2.14 System must provide “Buddy Watch” or equivalent feature for additional security so that if one portion of the apparatus goes down another working portion will alert the users, compatibility, and seamless integration with existing Centron or Presidio systems. The Buddy

Watch is a dialogistic software tool that allows multiple nodes to monitor each other in the event of catastrophic failure. Each node watches the partner node in front or behind to ensure the alarming capabilities and data logging are properly functioning. In the event of node failure, telephone failure, or connectivity failure, the partner node will alarm and call out on behalf of the troubled system to ensure the proper action is taken.

2.15 Reserved

2.16 Systems must be capable of giving a pre-alarm notification, dead man alarms, watchdog timers and back-up battery.

2.17 Systems must monitor, record, and alarm both on the network and in a stand-alone

(independent) fashion in the event of network failure or connectivity loss.

2.18 Systems must be compatible in a hard wired, wireless (418 MHz, 900 MHz and 2.4 GHz)

2.4 or in a combination of all 4 types in hybrid design in a single system.

2.19 The system must include cellular back up of a phone tree alert system.

2.20 The system must be compatible in a hard wired, wireless (418 MHz, 900 MHz and 2.4

GHz), or in a combination of all three types in a hybrid design in a single system.

2.21 The main monitoring nodes must provide power outage notification, dead man alarms, watchdog timers and back-up battery.

2.22 The system must be ISO 9001:2000 certified.

2.23 All vendor hardware wiring shall abide by the existing NIH/CIT Cable Standards and

Guidelines

(http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoli ciesandGuidelines/Pages/DesignRequirementsManualPDF.aspx). This also includes any new infrastructure that is required for this installation.

2.24 The Contractor is responsible to ensure that all accountable government property, i.e.

hardware, probes, etc. shall be delivered to the Pharmacy Procurement office at NIH Building

10 Room 1C-166.

2.25 The Contractor shall report all discrepancies noted that are not within the scope of this agreement to the NIH CC COR and the NIH CC Contracting Officer.

2.26 The Contractor is responsible to get any repair or replacement of components not within the scope of this agreement, which will result in additional cost approved by the NIH CC

Contracting Officer prior to procurement of the component and installation.