Medical Equipment Requirements Definition and

Technical Writing

FOR OFFICIAL USE ONLY

National Conference Center (NCC) Lansdowne, VA

June 4-6, 2012

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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

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Equipment Procurement

• Not Acceptable• Preferred model product

information• Vendor Language

• “See quote”• Utility/ Dimensional information of

the user preferred model itself

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Equipment Procurement

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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?

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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

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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

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Technical Specifications

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• 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)

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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.)

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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.)

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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.).

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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?

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Hours of Service

• National Agency Check• Common Access Card• Base Access• Training• Experience

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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?)

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• Compliance with DOD Information Assurance Requirements:• Software Maintenance• Bug Fixes• Cyber Threat Protection

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Information Assurance

• A Best Effort Contract says:1. You are maintaining obsolete Equipment, or2. 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.

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“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?

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• 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.

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First Look

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Questions