NHCP SOW TEMP SPECIFICATIONS.DOCX

SOW

(Statement of Work) The Government requests a Temperature Sensitive Remote Temperature/Humidity monitoring system with the following minimum specifications:

1. All systems must be compatible with continuous automated temperature monitoring to a limitless number of applications in a wide range of parameters from Pharmaceutical to Blood Banking, Laboratory Animal Research to Biotech Hospitals/clinics and NHCP network of care site. The system will also have the capacity to expand with the arrival on new equipment or spaces.

2. Meeting all specified government standards:

a. All protocols designed to meet today’s standards, including: Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Good Automated Manufacturing Practice (GAMP), Good Practice (GxP), Hazard Analysis Critical Control Point (HACCP), Joint Commission, U.S. Pharmacopeial Convention (USP) <800>, USP <797> and other regulatory requirements. Food and Drug Administration (FDA), American Association of Blood Banks (AABB), College of American Pathologists (CAP), Joint Commission, Association for the Advancement of Medical Instrumentation (AAMI), National Institute of Standards and Technology (NIST) and more are mandatory minimum requirements.

b. Interface portal should offer extensive reports and graphs and ensures data is secure and cannot be altered. Reports and graphs should allow local, un-restricted access to data and the ability to store information for 10 years.

c. System shall have capability for both wireless/WiFi and hard wired connections.

d. Vendor must be Authority to Operate (ATO) qualified before accepting RFI. Due to the time sensitive nature of this posting, we are unable to consider vendors that are not currently ATO qualified. They system will also comply with the DoD Information Assurance Certification and Accreditation process (DIACAP) and Risk Management Framework (RMF).

e. Able to transmit data from anywhere on the network of care sites and has a centralized webpage portal that can be accessed from any site with the system in place.

3. Monitors will be wall mounted and be able to:

a. Transmit through concrete, lead-lined and various other types of walls and materials

b. Two (2) sources of invasive/non-invasive temperature monitor

c. Provides a 24 hour battery power back-up system to allow for extended loss of power

4. Central or local monitoring station with the following capabilities:

a. Ability to monitor temperature from multiple locations

b. Ability to review data event log in day , week, and or month intervals

c. Ability to print event/log reports in day, week, month, and or year report

d. Data trending

e. Ability to review specific event(s) and document corrective actions

f. Ability to review loss of signal quality with time stamp

g. 100% secure DIACAP, RMF and ATO compliance

h. Access to live and stored data 24/7

i. Validated (Quality, Validation, System and Application Support)

i. ISO/IEC 17025 certified laboratory or ISO 9001 current version

ii. FDA 21CFR part 11 compliant current version

j. Immediate notification and alerting (email/Pagers/Cell Phones/Contact Switch/Voice Notification/Escalation Alert/Alarm Suspension)

k. Monitor multiple locations from web portal

l. Receive alerts via interactive phone, texts, and e-mails

m. Adjustable alarm temperature levels settings

5. Lab monitors with the following capabilities

a. Reach-in and walk-in type refrigerators

b. Ultra-low -80 degree C Freezers

c. Room Temp/Humidity

d. Door Ajar

e. Pressure Differential

f. Freezers

g. Water Bath

h. Cryogenics

i. Slide Warmer

j. CO2

k. Flood or Water leak

l. Power Outage

m. Ambient Light

n. Ability to transfer data between monitors seamlessly

6. Wireless/Hard-wired parameters:

a. Able to transmit data to central monitoring to/from anywhere on network of care sites

b. Ability to read data monitor

c. Offer solid buffering stability

d. Are fully FDA compliant

e. Back-up batteries are not proprietary and can be purchased from multiple locations in case of low stock

f. System will switch the battery power in the case of power outage

7. Temp tech monitoring system/monitors with the following capabilities

a. Ability to monitor more than 250 stations of varying makes/models

b. Store data for ten (10) years (ability to archive and retrieve at a later time)

c. Ability to print reports by users about the current performance

d. 24/7 monitoring capabilities

e. 24 hours, 7 days/week, 365 2 hour response time for critical and non-critical on-site support (critical/emergency will be defined as mission support and continuation with no interruption)

f. Continuous Monitoring for all capabilities on monitoring systems in facility/command (no loss of data) system will offer back up options

g. Digitally sign reports

8. Operating system requirements

a. Ability to easily adjust alarm parameters, set alarm parameter profiles by patient care area, and two alarm settings (soft and hard)

b. Offer a full array of validation, calibration and on-site training to fit specific needs of various technical levels. *Shall provide a minimum of ten (10) on-site training at the request of NHCP leadership.

c. Offers a knowledge base for quick reference when users are troubleshooting to minimize calling in to technical support.

d. Live, 24/7/365 technical support team to ensure requests are responded to promptly and closed out correctly.

9. Additional system requirements:

a. Vendor will provide all services, labor and equipment necessary for the annual validation calibration and qualifications of the system.

b. Application for command phone preferable

c. Ability to manage types of alarms and response via phone/text/e-mail

10. Maintenance

a. The scope of work performed under the specifications includes the furnishing of all labor, and parts to perform all repairs on equipment to assure continue operation at their designed efficiency and capacity.

b. The addition/relocation/ install of a probe will be done by the vendor or the vender will provide training to qualify an onsite authorized staff members or department.

c. The vendor will conduct quarterly inspection to ensure a functional system that will efficiently serve its intended purpose.