Medical Equipment Requirements Definition and Technical Writing FOR OFFICIAL USE ONLY National Conference Center (NCC) Lansdowne, VA June 4-6, 2012

FOR OFFICIAL USE ONLY 2 Context Requests for Equipment/Maintenance contracts must have clear and accurate requirements to ensure timely procurement and to minimize issues over the life of the equipment/contract Purpose Develop an understanding of the information required to formulate proper technical specification/ requirements for the submission process for procurement of equipment Develop an understanding of how to formulate requirements for maintenance requirements Objectives Have an understanding of the procurement process and important factors related to requirement generation Gain ability to generate requirements for both equipment and maintenance for submission into the procurement process Purpose and Objectives

Technical Requirements is the most crucial portion of a Command Equipment Request What products, available on the market, are capable of meeting your salient/minimum requirements Allow for competition whenever possible Sole Source Justification must be based on salient characteristics provided If requirements are sufficiently detailed, equipment that meets your minimum requirements will be procured FOR OFFICIAL USE ONLY 3 Equipment Procurement

Not Acceptable Preferred model product information Vendor Language “See quote” Utility/ Dimensional information of the user preferred model itself FOR OFFICIAL USE ONLY 4 Equipment Procurement

FOR OFFICIAL USE ONLY 5 Equipment Procurement Sole Sources Only one vendor/model is capable of meeting the minimum requirements specified. If justification uses “Best” or “Better”, not an acceptable sole source.

Define what functionality the unit/system will be used to achieve What environment/dept will it be used in? Sterile? What patient population will it be used on? What applications/ treatments/ capabilities should it be capable of providing? What is the correct ECRI Nomenclature? FOR OFFICIAL USE ONLY 6 Functional Requirements

Ranges/ Min-Max values (…shall be capable of a power range of 150W – 200W…) Word usage is important Room/Space Dimensions -space intended for equipment, not dimensions of suggested model (Unit of Measure) Electrical Requirements 50Hz OR 60Hz, amperage of outlet, single phase… Interface with other systems Anesthesia Unit/Monitoring to Innovian ARMD Accessories Requirements to meet intended functionality FOR OFFICIAL USE ONLY 7 Technical Specifications

Cleaning Requirements? New Technology – describe new technology and how it differs from previous technology and how it will benefit patient care Facilities Issues that affect specifications Water Supply Clean Power Med Gas Availability FOR OFFICIAL USE ONLY 8 Technical Specifications

FOR OFFICIAL USE ONLY 9 Required Delivery Date (consider ARO) Lease vs. Buy / Benefit-Cost Analysis Information Assurance Operating System EOL (Windows XP – April 2014) Installation/Trade-Ins/Turnkeys Equipment Transport through Facility Maintenance Requirements First Year Warranty “Additions” Part of Navy-wide Centralized Maintenance Contract? Site Specific Requirements Base Security/Access Requirements Safety Standards (OCONUS) Other Requirements

The ECRI Institute Product Comparisons Guidance Articles and Recommended Specifications Vendor list by Nomenclature/Device Code Clinicians/BMETs Previous Year Exhibitor Lists from Annual Conferences FDA’s Manufacturer and User Facility Device Experience (MAUDE) Service Inventories (JMAR) FOR OFFICIAL USE ONLY 10 Research Resources

Identify what is to be serviced. CLIN out each product with an individual price, no bulk contracts. (It must be possible to adjust contract pricing based upon a product being removed from service.) FOR OFFICIAL USE ONLY 11 Maintenance Requirements

Means of Quality Assurance – How do you plan to evaluate vendor performance? Uptime Guarantee OEM Parts Hours of Service Inspection for condition (OEM will accept unit at no cost to government.) FOR OFFICIAL USE ONLY 12 Quality Assurance on Service

Identify the level of service required: Preventive Maintenance Only? (And if so, WHY?) Scheduled and Corrective Maintenance, exclusive of parts? Scheduled and Corrective Maintenance, Inclusive of parts? Inclusive of Glassware? Coverage can vary by vendor (digital detectors, image intensifiers, CCD cameras, etc.). FOR OFFICIAL USE ONLY 13 Level of Service

When to consider 24/7 Service: If you only have one product Your facility is open and you use that product 24/7 When 24/7 service may not be required: If you have more than one of the product If that service is only open 7-5 M-F Perform a cost benefit analysis with every product: Expected cost of the higher level service versus the expected loss if that service is not available? FOR OFFICIAL USE ONLY 14 Hours of Service

National Agency Check Common Access Card Base Access Training Experience FOR OFFICIAL USE ONLY 15 Personnel Requirements

HIPAA Business Associates Agreements Business Associates Agreements are required for a majority of medical equipment contract. Subcontracting? (Justify need to know on a subcontract?) FOR OFFICIAL USE ONLY 16

Compliance with DOD Information Assurance Requirements: Software Maintenance Bug Fixes Cyber Threat Protection FOR OFFICIAL USE ONLY 17 Information Assurance

A Best Effort Contract says: 1. You are maintaining obsolete Equipment, or 2. You are contracting with someone not competent Under ANY circumstances, you should not be in a situation where a Best Effort Contract is appropriate. If you are considering this, CALL NMLC Engineers prior to proceeding. FOR OFFICIAL USE ONLY 18 “Best Effort Contracts”

What happens if a vendor can’t fix the equipment? The contract should clearly state if the contractor can not fix the equipment, are they obligated to replace it? If so, with a used product, new product of same capability or new product from same vendors? If not, why was there a contract? FOR OFFICIAL USE ONLY 19

Most vendors have minimal price reduction for first look contracts, because most facilities failed to honor their commitments under such contracts. The facility should maintain at least one trained person for the product under a first look contract. That person is obligated to attempt repair, spending approximately 4 hours trying to repair prior to calling for backup. FOR OFFICIAL USE ONLY 20 First Look

FOR OFFICIAL USE ONLY 21 Questions