18. DRAFT - DHA 27 52 33 Refrigerator Monitoring Systems.pdf

FOR OFFICIAL USE ONLY

(October 2018)

DHA PERFORMANCE STANDARDS

FOR

SECTION 27 52 33

REFRIGERATOR MONITORING SYSTEMS

10/18

TABLE OF CONTENTS

GENERAL

1.1 REFERENCES

2.1 DESCRIPTION & MATERIALS

3.1 SUBMITTALS

3.2 PERFORMANCE VERIFICATION AND ACCEPTANCE TESTING

3.2.1 Qualifications of Installers and Inspectors

3.2.2 Inspections and Tests to be Performed

3.3 WARRANTY

3.4 OPERATIONS AND MAINTENANCE (O & M)

GENERAL

This Performance Specification (PS) specifies the installation and quality of refrigerator monitoring systems.

Note: A typical monitoring system consists of a network of sensors that are linked together to form a temperature, humidity, and event alarm and logging system. Real property, including raceway, cable tray, junction boxes, etc. are addressed in their respective UFGS sections and not included in this specification.

1.1 REFERENCES

Contractor must comply with the following:

1.1.1 United Facilities Criteria (UFC)

A. UFC 1-200-01 General Building Requirements B. UFC 3-501-01 Electrical Engineering C. UFC 4-010-06 Cybersecurity D. UFC 4-510-01 Military Medical Facilities

1.1.2 Military Standard

A. Reserved for future

1.1.3 Military Health Services Standards

A. Food and Drug Administration

1. CFR Title 21, Chapter I B. Defense Health Agency Standards

1. Building Control Systems Categorization Memorandum

2. Cyber Security Controls for Physically Isolated Systems

3. Cyber Security Controls for Medical Community of Interest (MEDCOI)

C. Department of Defense Standards

1. Department of Defense Instruction (DoDI) Number 8500.01

2. Department of Defense Instruction (DoDI) Number 8510.01

1.1.4 Other Standards

A. American Association of Blood Banks (AABB) Standards

B. College of American Pathologists (CAP) Guidelines C. Department of the Army Supply Bulletin SB 8-75-11 D. World Health Organization Technical Report Series No. 961, Annex 9

2.1 DESCRIPTION & MATERIALS

2.1.1 General

A. Materials used must be suitable for the environment in which they are installed.

B. Monitoring system must be non-proprietary.

C. Utilize the most current approved version of Windows operating systems at the time of initial testing or as specifically approved for workstations and servers. Entire network must be supervised, monitored, patched, maintained, and life-cycled. Vendor must coordinate with Government to establish a plan of action for approval and dissemination of required Information Assurance Vulnerability Alert (IAVA) patches as well as software and security updates. Locate server in computer room (room code CMP01).

D. Disable any unused communications ports and protocols such that they can be reactivated by the government at a later date. Where Bluetooth functions are available, disable the Bluetooth functionality on delivery. The Bluetooth functionality must be able to be turned on after installation and review with the Cybersecurity Representative.

E. Monitoring system must provide monitoring 24 hours per day, 7 days per week.

F. System must provide storage for [[three] [___] years of data] [data in accordance with FDA regulations].

G. Provide local, wall mounted display of individual monitoring system inputs in [laboratories], [pharmacies], and [___].

H. Provide monitoring system with minimum [16] [___] input/output points. System must be expandable to [144] [___] input/output points.

I. Provide monitoring system and all remote sensors and alarm points with minimum [24] [___] hours of battery backup and battery condition indication.

J. Provide surge protection for monitoring system components.

K. Power cords must be a minimum [6] [___] feet in length.

L. System communication must be through [Bluetooth] [Wi-Fi] [Radio-Frequency 418/433 MHz] [900 MHz] [Cellular Dialer] [Category 6 cable] [___].

M. [System must interface to building management system through [Modbus][BacNet][___].

N. Provide cabling and other appurtenances in accordance with the manufacturer’s recommendations.

O. Coordinate with Medical Treatment Facility (MTF) IT department for currently installed servers, switches, PCs and other similar hardware components. Where no manufacturer’s requirements conflict, provide hardware components to be fully compatible with those currently installed in the MTF

P. System and other appurtenances must not have an anticipated end of system support in the next [18] [___] months.

Systems being phased out are not acceptable.

Q. [System must interface with Real Time Location System (RTLS).]

2.1.2 Temperature Monitoring System

A. Electronic sensors must be accurate to [+/-0.5°F] [___].

B. Provide [glycol] [glass bead] [[nylon][aluminum] block] thermal buffer to insulate temperature probes.

C. Locate sensors to be minimally affected by transient events such as door opening.

2.1.3 Temperature Controlled Rooms

A. Provide a temperature record with a minimum recording frequency of [[six] [___] times per hour] [continuous recording] for each monitoring sensor position.

B. Provide documentation for each monitoring sensor position, which can be stored and accessed.

2.1.4 Refrigerators and Freezers

A. Provide a multipoint monitoring system with [a minimum recording frequency of [six] [___] times per hour] [continuous recording] for each monitoring sensor.

B. Provide documentation for each appliance, which can be stored and accessed.

2.1.5 Humidity Monitoring System

A. Electronic sensors must be accurate to [+/-5% RH] [___].

B. Locate sensors to monitor worst-case humidity levels within the space/appliance.

C. Locate sensors to be minimally affected by transient events such as door opening.

D. Provide a humidity record with [a minimum recording frequency of [six] [___] times per hour] [continuous recording] for each monitoring sensor.

E. Provide documentation for each sensor position, which can be stored and accessed.

2.1.6 Alarm System

A. Provide with [local] [and] [central] alarm.

B. Alarm system must be integrated with the monitoring system.

C. Alarm system must trigger audio and visual alarms when high/low set points are exceeded.

D. Alarm system must trigger audio and visual alarms when power loss is detected.

E. Alarm system must trigger an alarm when loss of communication is detected.

F. Provide with programmable [automatic telephone dial-up], [email] [and] [SMS text warning system] to alert on-call personnel when an alarm is triggered outside on-duty hours.

3.1 SUBMITTALS

3.1.1 Submittals required for government review

A. Submittal requirements are outlined in [Division 01] [PWS SOW] [___].

B. [Submit the following for government review in addition to the submittal requirements in the [PWS SOW] [Division 1]

C. [Product Literature that includes manufacturers’ installation instructions, sizing, options, utility requirements and accessories being provided.] D. [Warranty information.] E. [Joint Interoperability Test Command (JTIC) Approval Documentation.] F. [Contact Information for Repair Technician or Emergency Repair Company] G. [Qualifications of installers and inspectors.] H. [Calibration Data] I. [Contact Information for Logistics, Pharmacy, Laboratory, and Medical Maintenance Personnel] J. [Specification Compliance Document]

3.2 PERFORMANCE VERIFICATION AND ACCEPTANCE TESTING

Install monitoring systems in accordance with manufacturer’s instructions. Demonstrate system is in operating condition in accordance with manufacturers’ specifications, and meets performance requirements stated in referenced criteria. Perform final verification and acceptance testing after facility construction is complete. If portions of the system were tested before final construction completion, retest system communications and functionality after completion of facility construction.

3.2.1 Qualifications of Company, Lead Installers, and Inspectors

A. Company specializing in installing the products specified in this section with minimum 5 years of documented experience.

B. Provide written Specification Compliance Document that the system and products submitted meet or exceed all requirements stated in this specification and referenced criteria as installed or that declares any omissions to the specification and referenced criteria compliance.

3.2.2 Inspections and Tests to be Performed

A. Calibrate devices against a certified, traceable reference standard. Calibration must demonstrate the accuracy of the unit across the entire [temperature] [and] [humidity] range over which the device is to be used.

B. Simulate a power outage to demonstrate functionality of back-up power system and power loss alarms.

C. Demonstrate functionality of interfaces to other systems and networks required.

D. Demonstrate implementation of cyber-security controls in accordance with DoDI 8510.

3.3 WARRANTY

3.3.1 Minimum Requirements

A. Warranty requirements are outlined in [Division 01] [PWS SOW] [___].

3.4 OPERATIONS AND MAINTENANCE (O & M)

3.4.1 Provide the following to the final owner

A. Provide O & M data for all FFE-LVS as outlined in [Division 01] [PWS SOW] [___].

B. Provide calibration verification, testing, certification and documentation 30 days prior to training sessions.

C. Train designated staff in the operation and maintenance of the provided system. Provide two training sessions for system users and two training sessions for maintenance personnel scheduled to accommodate shift work. [Eleven months after the system is installed, provide a refresher course for each group of trainees.] Provide video of the training with the O & M data.

--End of Section--