1. 1 FY02 ASA Presentation Preserve Valuable Animal Models Presented by: William F. Rall Physiologist, Special Breeding and Species Preservation Section DRSB, VRP Carl T. Hansen Geneticist, Special Breeding and Species Preservation Section DRSB, VRP Office of Research Services National Institutes of Health 18 November 2002

2. 2 Table of Contents Main Presentation ASA Template: Page 1 …………………….……………………………….4 Customer Perspective……………………….……………………………….5 Customer Segmentation …………………….……………………………………6 Customer Satisfaction……………………….……………………………… … 10 Unique Customer Measure: Increase Customer Base……...…………… …14 Internal Business Process Perspective………………………………… 16 Service Group Block Diagram………………………………………………….. 17 Deployment Flow Charts…………………………………………………………18 Conclusions from Discrete Services Deployment Flowcharts………………. 20 Process Measures………………………………………………………………..21 Learning and Growth Perspective………………………………………….28 Learning and Growth Data Table………………………………………………..29 Conclusions from Turnover, Sick Leave, Awards, EEO/ER/ADR Data……..30 Analysis of Readiness Conclusions…………………………………………….31 Financial Perspective………………………………………………………..33 Unit Cost……………………………………………………………………………34 Asset Utilization……………………………………………………………………35 Conclusions and Recommendations……………………………………….36 Conclusions from FY02 ASA..……………………………………………………37 Recommendations………………………………………………………………...40

3. 3 Table of Contents Appendices ASA Template: Page 2 ………………….……………………………….48 Analysis of Readiness Narrative ………….…………………………… 50

4. 4

5. 5 Customer Perspective

6. 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 Segmentation Perform Embryo Cryopreservation Services

7. 7 Customer Segmentation Perform Embryo Cryopreservation Services (cont.)

8. 8 Customers are quite diverse NCI is largest customer at 65% International community represents 20% of the customer base Customer Segmentation Maintain NIH Genetic Activity

9. 9 Customer Segmentation Maintain NIH Genetic Activity (cont.)

10. 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: DS1 Perform Embryo Cryopreservation Services

11. 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. : 2 used service in FY02. 3 intend to use services in FY03

12. 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. : 2 rated service Customer Satisfaction: DS1 FY02 Embryo Cryopreservation and Rederivation Services Satisfaction Ratings

13. 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: DS2 Maintain NIH Genetic Activity

14. 14 Unique Customer Measure: Increase Customer Base Perform 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. 15 Enhance NIHAGR homepage Establish collaborative projects Present seminars and posters at scientific conferences Respond to investigator inquiries Unique Customer Measure: Increase Customer Base Maintain NIH Genetic Activity

16. 16 Internal Business Process Perspective

17. 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. 18 Deployment Flow Chart: DS1

19. 19 Deployment Flow Chart: DS2

20. 20 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

21. 21 Process Measures Perform 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

22. 22 Process Measures Perform Embryo Cryopreservation Services (cont.)

23. 23 Process Measures DS1a: Number of Embryos Banked Note: The average number of embryos banked has significantly increased in FY02 as well as becoming increasingly stable.

24. 24 Process Measures DS1b: Number of Donor Females Processed Note: The average number of donors processed has significantly increased beginning in the second half of FY01.

25. 25 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 Measures Maintain NIH Genetic Activity

26. 26 Process Measures Maintain NIH Genetic Activity: DS2a, b, c - Mice

27. 27 Process Measures Maintain NIH Genetic Activity: DS2a, b, c - Rats

28. 28 Learning and Growth Perspective

29. 29 About 3 days sick leave per employee No Awards 12% employee turnover 2 ER cases out of 8 employees Learning and Growth Data Table Preserve Valuable Animal Models

30. 30 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

31. 31 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 Conclusions Perform Embryo Cryopreservation Services

32. 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 Conclusions Maintain NIH Genetic Activity

33. 33 Financial Perspective

34. 34 Unit Cost Preserve Valuable Animal Models

35. 35 Asset Utilization Preserve Valuable Animal Models 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

36. 36 Conclusions and Recommendations

37. 37 Conclusions from FY02 ASA Perform 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

38. 38 Conclusions from FY02 ASA Perform Embryo Cryopreservation Services (cont.) Unit Cost is a problematic area.

39. 39 Conclusions from FY02 ASA Maintain 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. 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 Recommendations Perform Embryo Cryopreservation Services

41. 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 Recommendations Perform Embryo Cryopreservation Services

42. 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) Recommendations Perform Embryo Cryopreservation Services (cont.)

43. 43 White light

44. 44 Long wave UV light

45. 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 Recommendations Maintain NIH Genetic Activity

46. 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 Recommendations Maintain NIH Genetic Activity (cont.)

47. 47 Appendices

48. 48 Appendices ASA Template: Page 2

49. 49 Appendices ASA Template: Page 3

50. 50 Appendices Analysis 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. 51 Appendices Analysis 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.