Attached_J.7_Technical_Scenarios.pdf

PDF 145 KB Posted Jul 12, 2017

Attached to: Scientific Instrument Maintenance and Repair Services
Solicitation number: FDA-17-223-SOL-00019
Issued by: Department of Health and Human Services Food and Drug Administration

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Attached J.7 Technical Scenarios

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File	Type	Posted
AMENDMENT_0003_QUESTIONS_AND_ANSWERS_17-223-SOL-00019.pdf	PDF	Aug 3, 2017
AMENDMENT_0002_QUESTIONS_AND_ANSWERS_17-223-SOL-00019.pdf	PDF	Jul 24, 2017
AMENDMENT_0001.pdf	PDF	Jul 18, 2017
Attachment_J.7.1_Technical_Scenario_Instruments_Pricing_Table.xls	XLS spreadsheet	Jul 12, 2017
Attachment_J.6_Acronyms.pdf	PDF	Jul 12, 2017
Attachment_J.2_Service_Coverage_Plans.pdf	PDF	Jul 12, 2017
RFP_17-223-SOL-00019_.pdf	PDF	Jul 12, 2017
SF_33-FDA-17-223-SOL-00019.pdf	PDF	Jul 12, 2017
Attachment_J.4_Example_Service_Request_Form.pdf	PDF	Jul 12, 2017
Attachment_J.8_Personnel_Security_Clearance_Requirements.pdf	PDF	Jul 12, 2017
Attachment_J.5_Definitions.pdf	PDF	Jul 12, 2017
Attachment_J.1_Master_Equipment_List.pdf	PDF	Jul 12, 2017
Attachment_J.3_Service_Request_Process.pdf	PDF	Jul 12, 2017
SYNOPSIS_FDA_17-223-SOL-00019.pdf	PDF	Jul 12, 2017

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ATTACHMENT J‐7

TECHNICAL SCENARIOS

Technical Scenario #1 Project Management Services

The

FDA

possesses

well

over

1000

instruments

and

pieces

equipment

that

are

the

subject

this

contract.

representative

sample

those

instruments

summarized

Table

for

the

purposes

this

technical

scenario.

Table

lists

instruments

considered

under

this

technical

scenario.

Column

definitions

for

Table

are

follows:

A. Line	Number
B. Instrument	Type:	general	category	of	instrument	(LC/MS/MS	triple	quadrupole	MS,

NMR).

C. OEM:

original

equipment

manufacturer

(OEM)

name.

D. Model:

model

name

number.

E. Value:

approximate

value

when

installed.

F. Date:

dates

over

which

that

type

instrument

was

installed

the

FDA.

G. Number

Full

Service

Contracts

required

from

OEM

Offeror:

stated

for

the

model

numbers	specified.
H. Preventive	Maintenance	Contract	Required:	as	stated	for	the	model	numbers	specified.
I. Time	and	Materials	Coverage	Required:	indicates	the	number	of	additional	instruments

that

category

for

which

only

time

and

materials

coverage

are

required.

J. Provide

Narrative:

specifies

whether

brief

narrative

needed

for

that

instrument,

described

below.

Provide

pricing

for

Full

Service

contracts

specified

column

L. Provide

pricing

for

Preventive

Maintenance

contracts

specified

column

M. Provide

pricing

(per

repair

call

fees,

etc.)

for

unscheduled

repairs

(time

and

materials)

on instruments in column I (e.g. instruments not covered by fixed price service or PM plans).

Provide

response

that

addresses

questions

a‐e

Sections

and

below

for

the

entries

identified

Table

elements

your

response

carry

over

from

one

line

the

table1,

you

may

provide

common

narrative

that

will

cover

all

the

common

elements

and

then

specify

line

number

the

information

that

differs

from

line

line:

A. Full service contract and preventive maintenance (PM) agreements (fixed price contracts):

a. Can

the

offeror

provide

its

own

service

contract

and/or

agreements

the

specific

instruments

question?

b. What	would	be	covered	under	the	contract/PM	agreements	and	are	there
different	levels	of	coverage?

c. Who

would

provide

the

actual

service

under

your

plan?

only

the

OEM

can

provide

service

the

instrument

question

(or

the

FDA

specifies

only

the

OEM

may

provide

service

that

instrument),

how

you

would

work

with

the

OEM

under

your

service

contract

agreement?

d. Would

you

use

third

party

service

providers

support

your

contract

agreement

and

how

would

you

verify

the

FDA

that

they

meet

the

qualifications

outlined

the

contract?

e. In

the

event

you

not

offer

full

service

contracts

agreements,

the

event

specific

FDA

request

for

OEM

service

contract

agreement,

are

you

able

purchase

OEM

service

contracts

agreements

for

the

specified

instruments

behalf

the

FDA?

Demonstrate

that

your

relationship

with

the

OEM

enables

you

this.

B. Time and Materials Repairs:

a. For

the

instrument(s)

identified,

are

you

able

obtain

time

and

materials

repairs

from

the

OEM

behalf

the

FDA?

you

have

agreements

place

with

the

OEM,

past

experience

with

the

OEM,

confirm

this?

b. Are

you

able

obtain

one‐time

preventive

maintenance

visits

(not

part

agreement)

from

the

OEM?

c. Do

you

plan

use

third

party

service

providers

for

time

and

materials

repairs,

and

so,

how

will

you

verify

they

meet

the

qualification

standards

outlined

the

SOW?

d. On

occasion,

FDA

may

initiate

time

and

materials

service

request

and

terminate

the

request

before

the

service

actually

ordered

performed.

How

will

you

address

situations

where

the

FDA

may

ask

you

perform

only

part

the

service

call

process?

e. Where	off‐site	(depot)	repairs	or	repairs	with	equipment	exchange	are	required,
how	would	these	repairs	get	handled?

Technical Scenario #2 Management and coordination of services:

For the situations outlined in section A below, describe how repair services would be handled. Provide at minimum the information required under section B and if an electronic or web‐based service call system is used, please indicate how it is integrated into the process. If your system would be the same in each case, there is no need to repeat information under each situation; simply note any new elements in that situation.

A. Situations

a. Emergency repair (2‐day turnaround) for Illumina MiSeq instrument under full contract

(scenario Table 1, line 6).

b. Preventive maintenance visit for AB Sciex 6500Q under PM agreement (scenario Table

1, line 1).

c. Emergency repairs (2‐day turn around) under time and materials coverage for Agilent

600 MHz NMR (scenario Table 1, line 3).

d. Depot repair for liquid chromatograph component (scenario Table 1, line 10, time and materials).

e. Repair with exchange for liquid chromatograph component (scenario Table 1, line 10 time and materials coverage).

B. Information required

a. Mechanism for obtaining a service request.

b. Actions upon receipt of service call.

c. Methods for obtaining quotes for service, if necessary under the coverage.

d. Setting a Not to Exceed level and approval of service at the center level, if necessary under the specified coverage.

e. Real‐time tracking of service in progress.

f. Close‐out of service when complete, including obtaining field service reports and authorizing payment to the service provider.

g. Mechanism for obtaining feedback from the end user.

File details come from the government source that posted it. Updated Nov 14, 2017.