1

FY02 ASA Presentation

Preserve Valuable Animal Models

Presented by:

William F. RallPhysiologist,Special Breeding and Species Preservation SectionDRSB, VRP

Carl T. HansenGeneticist,Special Breeding and Species Preservation SectionDRSB, VRP

Office of Research ServicesNational Institutes of Health

18 November 2002

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Table of Contents

Main PresentationASA Template: Page 1 …………………….……………………………….4Customer Perspective……………………….……………………………….5

Customer Segmentation …………………….……………………………………6Customer Satisfaction……………………….……………………………… … 10Unique Customer Measure: Increase Customer Base……...…………… …14

Internal Business Process Perspective………………………………… 16Service Group Block Diagram………………………………………………….. 17Deployment Flow Charts…………………………………………………………18Conclusions from Discrete Services Deployment Flowcharts………………. 20Process Measures………………………………………………………………. .21

Learning and Growth Perspective………………………………………….28Learning and Growth Data Table………………………………………………..29Conclusions from Turnover, Sick Leave, Awards, EEO/ER/ADR Data……..30Analysis of Readiness Conclusions…………………………………………… .31

Financial Perspective………………………………………………………..33Unit Cost……………………………………………………………………………34Asset Utilization……………………………………………………………………35

Conclusions and Recommendations……………………………………….36Conclusions from FY02 ASA..……………………………………………………37Recommendations………………………………………………………………...40

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Table of Contents

AppendicesASA Template: Page 2 ………………….……………………………….48Analysis of Readiness Narrative ………….…………………………… 50

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Team Members

Patricia M. Schmidt, A. Chris Ward, Margaret Novicky

Product Leadership Harvest

Dr. William F. Rall and Dr. Carl T. Hansen

Operational Excellence Growth

Service Strategy

ASA Template - 2002

Customer Value Proposition

Team Leaders

Preserve Valuable Animal Models

Discrete Services

Service Group

Customer Intimacy Sustain

Provide the NIH biomedical research community with customized and conveniently located research support services for the development and preservation of unique animal models.

DS1: Perform Embryo Cryopreservation Services

DS2: Maintain NIH Genetic Activity

X X

5

Customer Perspective

6

• Cryopreservation and rederivation services are utilized by 10 of the 16 ICs conducting rodent research

• 4 ICs have “in house” programs or contract out• General trend is increasing need• Current work load is dominated by 3 large

projects (2 have reducing needs)• Customer segmentation is analyzed in terms of

the revenue generated by each institute, large IAA projects are considered as a separate item

Customer SegmentationPerform Embryo Cryopreservation Services

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Customer SegmentationPerform Embryo Cryopreservation Services (cont.)

FY01 revenue

$0

$50,000

$100,000

$150,000

$200,000

$250,000

NIAM

S pro

ject

NIHAGR p

rojec

t

NIDDK

NIA p

rojec

t

NIAID

NIAM

S NEI

NIDCR

FY02 revenue

$0

$50,000

$100,000

$150,000

$200,000

NIHAGR p

rojec

t

NIAM

S pro

ject

NIHAGR te

chnic

ian

NIAID

tech

nician

NIDDK

NIAID

pro

ject

NIA p

rojec

t

NINDS

NCI

NIDCR

NICHD

VRCNIA

ID

NIAM

S

8

• Customers are quite diverse• NCI is largest customer at 65%• International community represents 20% of

the customer base

Customer SegmentationMaintain NIH Genetic Activity

9

Customer SegmentationMaintain NIH Genetic Activity (cont.)

NIHAGR DISTRIBUTION

62%14%

19%

5%

NCI

International

Domestic

NIH

10

• 8 out of 69 surveys (12.5%) were returned• Most respondents were veterinarians• Insufficient data to make judgments (2 rated

service)• Scores received were low, presumably

reflecting concerns on recent animal health issues

• Need to develop survey instruments that better identify discrete services

• Need a higher response rate

Customer Satisfaction: DS1Perform Embryo Cryopreservation Services

11

Customer Satisfaction: DS1 FY02 Embryo Cryopreservation and Rederivation Services Usage

Note: Service usage for FY02 is shown on left. Intended use is shown on right.

0%

20%

40%

60%

80%

100%

Used in FY02 Will Use in FY03

Pe

rce

nta

ge

of

Re

sp

on

de

nts

No

Yes

Data based on 8 respondents : 2 used service in FY02. 3 intend to use services in FY03

12

Note: The rating scale ranges from 1 - 10 where “1” represents Unsatisfactory and “10” represents Outstanding. Of the respondents who used the service in FY02, the percentage of respondents choosing each scale point is depicted.

90%

80%7

0%

650%

50%

Outstanding 100%

250%

30%

Unsatisfactory 10%

40%

Data based on 8 respondents : 2 rated service

Customer Satisfaction: DS1 FY02 Embryo Cryopreservation and Rederivation Services Satisfaction Ratings

13

• Web survey currently being piloted• Satisfaction is only one component• Main focus is on evaluating future customer

requirements• Respondents will include representatives

from international, national, and on-campus communities

Customer Satisfaction: DS2Maintain NIH Genetic Activity

14

Unique Customer Measure: Increase Customer BasePerform Embryo Cryopreservation Services

• New quarantine facility established in Building 14EN will increase need for rederivation services

• New rederivation lab in 14BN will reduce likelihood of contamination by pathogens

• Expanding service capacity requires additional technician(s)

• Rederivation projects require more interactions with customers than banking projects

• FY03 goal: 65 rederivations

15

• Enhance NIHAGR homepage• Establish collaborative projects• Present seminars and posters at scientific

conferences• Respond to investigator inquiries

Unique Customer Measure: Increase Customer BaseMaintain NIH Genetic Activity

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Internal Business Process Perspective

17

Service Group Block Diagram

• The two discrete services are closely interdependent with extensive interactions• e.g., NIAMS IAA autoimmune rat center project

• Both discrete services rely on other VRP units for critical services • Animal holding• Veterinary Medicine• Health testing• Genotyping

Perform Embryo Cryopreservation

Services

Maintain NIH Genetic Activity

18

Embryo Banking Services to a NIH Intramural Investigator

ECPLab Head

ECPCoordinatingTechnician

ECPTechnicians

VRPAnimal HealthSurveillance

IntramuralInvestigator

Request forInfo

or Services Is this FirstContact?

PreparesAnimalModel

DescriptionForm

Meet withInvestigators to Discuss

Service &Options

Is InfoComplete?

ContactInvestigator

forClarification

IsInvestigator

Ready toStart

RecontactInvestigatorPeriodically

InvestigatorPrepares &

ShipsPregnantFemale

GenotypingVerification

Ship Rederivedpups

to Investigators (oreuthanize)

IsRederivation,

Genotyping andSerology

Completed?

RecontactAppropriate

People

BillCustomer

Can #

ScheduleEmbryo

CollectionDate

Is EmbryoBanking,

Completed?

RecordResults

in Database

Collect,Cryopreserve

&Store

Embryos

QualityControl

Rederivation

Serology ofFoster

Mothers

Yes

No

No

Yes

Yes

Yes No

Yes

No

No

Deployment Flow Chart: DS1

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Deployment Flow Chart: DS2Bank Embryos for Each NIH Animal Genetic Resource Mouse & Rat Model

NIH AGR Technician ECP TechniciansGeneticist

EmbryoBanking

Completed?

ReviewResults

AssignDatabaseID Number

Prepare andMate

Female

SendAnimals and

DatabaseInformation

toECP

Collect,Cryopreserve,

andStore

Embryos

PerformQualityControl

Rederivation

RecordResults

inDatabase

No

DesignateEmbryoDonors

YesBank

Established

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• Our Service Group completed 2 deployment flowcharts for 2 discrete services

Conclusions from flowcharts:• Assisted in improving DS1 processes:

• Customer contacts (information, expectations)• Decision points • Record keeping (spreadsheets) and remote access (server)

• Assisted in identifying internal business process measures

• DS1: Number of embryo donor females processed • DS2: Number of animal cages

Conclusions from Discrete Services Deployment Flowcharts

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Process MeasuresPerform Embryo Cryopreservation Services

• DS1a: Number of embryo donors processed• DS1b: Number of embryos banked• Findings

• The average number of donors processed has significantly increased beginning in the second half of FY01

• The average number of embryos banked has significantly increased in FY02 as well as becoming increasingly stable

• Capacity growth is closely linked to number of trained technicians

• Number of embryo donors processed is best overall operational measure

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Process MeasuresPerform Embryo Cryopreservation Services (cont.)

0

1000

2000

3000

4000

5000

FY 003Q

FY 004Q

FY 011Q

FY 012Q

FY 013Q

FY 014Q

FY 021Q

FY 022Q

FY 023Q

FY 024Q

Number of embryo donors processed (DS1a)

Number of embryos banked (DS1b)

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Process MeasuresDS1a: Number of Embryos Banked

Note: The average number of embryos banked has significantly increased in FY02 as well as becoming increasingly stable.

Moving Range: Embryos Banked

0

1000

2000

3000

4000

Quarter/Year

Mo

vin

g R

ang

e (m

R)

Moving Range 1210 1158 633 1175 693 1161 77 75 324

Q4 FY00 Q1 FY01 Q2 FY01 Q3 FY01 Q4 FY01 Q1 FY02 Q2 FY02 Q3 FY02 Q4 FY02

UCL = 3182

mR = 974

mR = 159UCL = 519

Signal

Individual Values: Embryos Banked

0

1000

2000

3000

4000

5000

6000

Quarter/Year

Ind

ivid

ual

Val

ues

(X

)

# Embryos Banked 2232 3442 2284 2917 4092 3399 4560 4483 4408 4084

Q3 FY00 Q4 FY00 Q1 FY01 Q2 FY01 Q3 FY01 Q4 FY01 Q1 FY02 Q2 FY02 Q3 FY02 Q4 FY02

Mean = 3061

Mean = 4384

UCL = 4806

LCL = 3962

UCL = 5651

LCL = 471

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Process MeasuresDS1b: Number of Donor Females Processed

Note: The average number of donors processed has significantly increased beginning in the second half of FY01.

Moving Range: Donors Processed

0

100

200

300

400

500

600

Quarter/Year

Mo

vin

g R

an

ge

(m

R)

Moving Range 29 83 111 503 261 165 106 47 288

Q4 FY00 Q1 FY01 Q2 FY01 Q3 FY01 Q4 FY01 Q1 FY02 Q2 FY02 Q3 FY02 Q4 FY02

UCL = 243

mR = 74 mR = 174

UCL = 567

Individual Values: Donors Processed

500

1000

1500

2000

Quarter/Year

Ind

ivid

ua

l Va

lue

s (

X)

# Donors Processed 852 881 798 909 1412 1151 1316 1422 1375 1087

Q3 FY00 Q4 FY00 Q1 FY01 Q2 FY01 Q3 FY01 Q4 FY01 Q1 FY02 Q2 FY02 Q3 FY02 Q4 FY02

Mean = 860

Mean =

UCL = 1755

LCL = 833

UCL = 1058

LCL = 662

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• DS2a: Number of cages (mice and rats)• DS2b: Number of embryo donors sent (mice and

rats)• DS2c: Number of embryos banked (mice and rats)

• Findings:• Mouse and rat

• Number of cages changed over time• Reduction in number of cages, female donors and embryos

banked after January 1998 reflect the success of embryo banking

• Rat• Increase in number of cages, female donors and embryos

banked in January 2000 resulted from start of NIAMS rat project

Process MeasuresMaintain NIH Genetic Activity

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Process MeasuresMaintain NIH Genetic Activity: DS2a, b, c - Mice

0

5000

10000

15000

20000

25000

7/89-1/90

7/91-12-91

1/94-6/94

1/196-6/96

1/98-6/98

1/00-6/00

1/02-6/02

CAGES DONORS EMBRYOS FROZEN

27

Process MeasuresMaintain NIH Genetic Activity: DS2a, b, c - Rats

01000

20003000

40005000

60007000

80009000

10000

CAGESDONORSEMBRYOS FROZEN

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Learning and Growth Perspective

29

Pop

ulat

ion

Est

imat

e

No.

of S

epar

atio

ns

Turn

over

Rat

eTo

tal H

ours

of S

ick

Leav

e U

sed

Ave

rage

Hou

rs o

f

Sic

k Le

ave

Use

d

Num

ber

of A

war

ds

Rec

eive

dA

vera

ge N

umbe

r of

Aw

ards

Rec

eive

d

Num

ber

of E

EO

Com

plai

nts

Ave

rage

Num

ber

of

EE

O C

ompl

aint

s

Num

ber

of E

R C

ases

Ave

rage

Num

ber

of

ER

Cas

esN

umbe

r of

AD

R

Cas

esA

vera

ge N

umbe

r of

AD

R C

ases

57384 8 1 0.12 204 24 0 0.00 0 0.00 2 0.24 0 0.00Service

Group 23 Total

8 1 0.12 204 24 0 0.00 0 0.00 2 0.24 0 0.00

About 3 days sick leave per employee

No Awards

12% employee turnover

2 ER cases out of 8 employees

Learning and Growth Data TablePreserve Valuable Animal Models

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Data provided by HR:• Twelve percent employee turnover• About 3 days sick leave used per employee• No Awards• 2 ER cases out of 8 employees

Conclusions from Turnover, Sick Leave, Awards, EEO/ER/ADR Data

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• Elimination of pathogens, maintenance of desired genotype, and secure cryostorage facilities are essential for banking and rederivation services

• Rederivation lab is moving to Building 14BN• Expect growth

• Need to hire and/or provide cross-training• Need additional equipment (budget must be

developed)• Possible need additional lab space

• Retention and retirement of staff impacts ability to maintaining service capacity and quality

Analysis of Readiness ConclusionsPerform Embryo Cryopreservation Services

32

• Results of detailed survey of customers will drive future direction

• Resolve funding issues• Right sizing• Greater reliance on cryopreserved embryos• Animal health and genetic integrity are essential for

success of service

Analysis of Readiness ConclusionsMaintain NIH Genetic Activity

33

Financial Perspective

34

Unit CostPreserve Valuable Animal Models

Discrete Service Unit Definition # Units Total Direct Cost Unit Cost

DS1: Perform embryo cryopreservation services

Number of embryo donors processed

5,200 $823,704 $158

DS2: Maintain NIH animal genetic activity

Number of animal cages

1,500 $1,379,011 $919

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Asset UtilizationPreserve Valuable Animal Models

Discrete Service Unit Definition #

Units

Estimated Asset Utilization

(actual/maximum)

DS1: Perform embryo cryopreservation services

Number of embryo donors processed

5,200 70%

DS2: Maintain NIH animal genetic activity

Number of animal cages

1,500 100%

Asset Utilization Notes:• DS1: Maximum capacity = expected # females

processed per day (15/day/employee) times # of employee days (493)

• DS2: Maximum capacity = expected all available animal cages to be used

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Conclusions and Recommendations

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Conclusions from FY02 ASAPerform Embryo Cryopreservation Services

• As illustrated by customer segmentation revenue data, customer survey data, and process measure data, the general trend is an increasing need for cryopreservation and rederivation services

• The survey response rate is insufficient to draw conclusions about service quality or satisfaction

• Expected growth will dictate need for additional personnel, cross-training of current personnel, additional equipment, and possibly additional space

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Conclusions from FY02 ASAPerform Embryo Cryopreservation Services (cont.)

• Unit Cost is a problematic area.

39

Conclusions from FY02 ASAMaintain NIH Genetic Activity

• The customer base is diverse. While NCI is the largest customer accounting for approximately 65% of activity, the national and international community represents approximately 30% of activity

• The survey currently being piloted will provide much needed information regarding the future direction of this activity.

40

• Continue tracking customer segmentation revenue data in FY03

• Develop and implement customer satisfaction survey that better identifies this discrete service area

• Follow-up on customer responses to survey with reminder

• Continue tracking number of donor females processed and number of embryos banked using behavior process control charts during FY03

RecommendationsPerform Embryo Cryopreservation Services

41

• Attain goal of 65 rederivations in FY03• Develop budget requirements for additional

equipment as needed• Hire additional contract technician(s) as

needed• Address cross-training needs of current

personnel• Work with OBSF and VRP business

personnel to better define/capture unit cost data

RecommendationsPerform Embryo Cryopreservation Services

42

• Respond to customer inquiries on animal model development, preservation and rederivation

• Present seminar and visit new customers to describe cryopreservation and rederivation services

• Present posters and distribute brochure at NIH Research Festival

• Provide brochure at NIH Orientation Fair • Post “Cool Picture” of new mouse model (green

mice) in DDIR bulletin board (see next slide)

RecommendationsPerform Embryo Cryopreservation Services (cont.)

43

White light

44

Long wave

UV light

45

• Continue tracking customer segmentation data in FY03

• Implement pilot web survey by end of Q1 FY03• Analyze survey results by January 31, 2003• Use survey results to help shape future

direction of this service as well as to improve selected components of current service

• Continue tracking number of cages, number of embryo donors sent, and number of embryos banked for both mice and rats during FY03

RecommendationsMaintain NIH Genetic Activity

46

• Rederive mice in Building 14F barrier to eliminate pathogens by end of FY03 (in collaboration with Veterinary Medicine Branch)

• Enhance NIHAGR homepage• Establish collaborative projects• Present seminars and posters at scientific

conferences• Respond to investigator inquiries• Work with OBSF and VRP business personnel to

better define/capture unit cost data

RecommendationsMaintain NIH Genetic Activity (cont.)

47

Appendices

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AppendicesASA Template: Page 2

Increase customer satisfaction Customer satisfaction ratings from the ORS Customer Scorecard for each Discrete Service

DS2: Number of embryo donors sent (rats)

DS2: Number of embryo donors sent (mice)

DS2: Number of embryos banked (mice)

DS2: Number of cages (rats)

Customer PerspectivePerformance Measure

DS1: Number of rederivations (FY03)

Customer segmentation of Discrete Services

Performance Objective

Increase understanding of customer base

Service Group: Preserve Valuable Animal Models

DS1: Number of donor females processed

Identify methods to measure processes.

DS1: Number of embryos banked

Identify and report on process measures for Discrete Services

DS2: Number of embryos banked (rats)

Increase understanding of processes.

Increase customer base

Performance Objective Performance MeasureInternal Business Process Perspective

Complete process maps of Service Group/Discrete Services

DS2: Number of cages (mice)

49

AppendicesASA Template: Page 3

Actual assets utilized/planned asset utilization for each Discrete ServiceMaximize utilization of assets.

Turnover

Maintain & enhance competencies for the future organization. Analysis of Readiness Index

Performance Objective

Sick Leave Usage

Enhance quality of work life for employees in ORS.

Learning and Growth Perspective

Change in Unit Cost for each Discrete ServiceMinimze unit cost at a defined service level.

Performance Objective Performance Measure

Financial Perspective

Performance Measure

Awards/Recognition

Contacts/Complaints with EEO/ER/ADR

50

AppendicesAnalysis of Readiness Narrative

The Service Group assessed anticipated needs for the next three years and concluded that additional personnel, equipment, and perhaps laboratory space will be needed to address the anticipated growth in the demands for cryopreservation, rederivation and animal model development services. The current mix of skills and abilities of current personnel should be able to carry out the mission of the service group. Two key employees are currently eligible to retire on full benefits, but have not indicated any desire to do so. The duties of these individuals are critical to the continuation and improvement of the quality and quantity of services to investigators. It is anticipated that several methods might be used to hire suitable personnel as replacements (or for increasing capacity), such as contract employees, reassignment of employees from other VRP/ORS components, cross-training current personnel for advancement, and hiring new GS employees. In any event, a 4-6 month training period is required to learn and master embryo cryopreservation or genetic resource protocols. Experience indicates that not all candidates are capable of mastering some critical skills, presumably as yet undefined deficiencies in binocular vision or hand-eye coordination using a stereomicroscope.

The cryopreservation of mouse and rat spermatozoa is one specific area where scientific improvements may soon warrant the inclusion of sperm cryopreservation in the portfolio of services. The development of sperm cryopreservation service would require a modest amount of in-house research & development to optimize protocols for current equipment and specific needs at the NIH. It is anticipated that other research and development is needed to address specific questions and opportunities to improve the efficiency and efficacy of current “embryo” methodologies (superovulation, estrus synchronization, collection, cryopreservation, and transfer).

51

AppendicesAnalysis of Readiness Narrative

A mechanism to support and fund such research activities is needed to retain and recruit Ph.D. scientists to run VRP cryopreservation, genetic resource, and other programmatic activities. This is one missing component in the continuing education, professional advancement, and development of VRP Ph.D. experts for collaborations with intramural scientists.

The capture and management of data related to the animals, embryos, and the processing of both is a requirement for our services. The current Colony/Facility database system captures animal and embryo information for the NIHAGR. This has been funded by the NIAMS IAA project. That project is expected to conclude in FY04 and a new funding mechanism must be identified. Embryo cryopreservation and rederivation database is currently maintained as Excel spreadsheets. There is a need to convert to a relational database system (e.g., Access) to deal with the large amount of information being generated.

Our reliance on services and expertise from other components of VRP can not be overemphasized. High quality animal holding, health testing, veterinary medicine, and genotyping are required to provide high quality and efficient services. A problem in any of these components will have a deleterious impact on our services. For example, the embryo transfer laboratory is in the process of being transferred to 14BN, VRP’s only “clean” animal holding facility. The outbreak of a rodent disease in the facility housing the embryo recipients colony or foster mothers, an inaccurate health test ,or animal mating/genotyping error would detrimentally affect our customers and may result in the extinction of an unique animal model. A comprehensive plan detailing the steps to be taken in the event of any of these problems is urgently needed.