# Presentation: 938206

## CDRH FY 05 Scorecard Report Through Three Quarters 

**Robert Navazio 9/1/05**

**The “Yugo” version 05**
**At a glance....**

## Summarize Center-Wide FY 05 data cumulatively through three quarters
Identify areas where we have good data and areas where we still have problems with data collection
Discuss how we are using Office and Center results to manage our programs in FY 05
Provide background to Executive Committee to make decisions on FY 06
scorecard numerators and denominators
performance targets

- Identify areas where we have good data and areas where we still have problems with data collection
- Discuss how we are using Office and Center results to manage our programs in FY 05
- Provide background to Executive Committee to make decisions on FY 06
- scorecard numerators and denominators
- performance targets

**Purpose of Presentation**

## Are We Meeting our Targets? (Have we set targets?)

**Are We Meeting our Targets? ****(Have we set targets?)**

- KRA 1 :**Public Health Promotion**

**Y**

- KRA 2: **Public Health Protection**

- KRA 3: **Effective Management in **
**       ****Accordance with TPLC**

- KRA 4: Knowledge Management  and
-          **Stakeholder Collaboration**

- KRA 5: **Workforce Excellence**

*Green:  ****Meeting Targets***
*       **Yellow:  ****Not Meeting all ******	******Targets: Need to ******	******review + drill down***
*     **Red:   ****More than X% of      ******	******measures not meeting ******	******targets**** (need to review)*
*     **White:  ****Need to work on ******	******setting the right ******	******measures + targets***

**G**

**Y**

**Y**

**W**

## Keep in Mind (What gets measured gets done!)

- Measures: the fewer the better
- Measures should be intermediate outcome based whenever possible (not just outputs)
- Measures focus on key success factors
- Measures should be integrated through the organization
- Measures need to have targets from baseline data rather than arbitrary numbers

## KRA 1:  Performance Updates for MDUFMA  Decision Goals and Cycle Actions:  FY 04 Receipt Cohort (as of 6/30/05)

** ****Expedited PMAs with an FDA Decision within 300 total FDA days **
** ****and on-time cycle actions **

|  | 3 Quarters
FY 05 |
| --- | --- |
| # Meeting goal | 25 |
| # Not Meeting goal | 11 |
| # Awaiting MDUFMA Decision | 4 |
| Total Received and Filed in Receipt Cohort | 14 |
| Total Received | 14 |

-            Best
-       Case 80%
-        29 of 36

- FY 05
- Dec.
- Target
- 70%

- Worst Case 69%
- 25 of 36

**Includes 10 of 14 on-time decisions**
**Includes 15 of 22 on-time cycle actions**

## KRA1:  Performance Updates for MDUFMA Decision Goals and Cycle Actions: FY 04 Receipt Cohort (as of 6/30/05)

**   ****Original PMAs and PMA Panel Track Supplements with an FDA decision within 320 total FDA days and on-time cycle actions**

|  | 3 Quarters
FY 05 |
| --- | --- |
| # Meeting Goal | 82 |
| # Not meeting goal | 7 |
| # Awaiting MDUFMA Decision | 9 |
| Total Received and Filed in Receipt Cohort | 47 |
| Total Received | 47 |

- FY 06
- Dec. Target
- 80%

- Worst Case
- 84%
- 82 of 98

**Includes 37 of 38 on-time decisions**
**Incudes 45 of 51 on-time cycle actions**

**     ****Best Case**
**93% (91 of 98)**

## KRA 1:  Performance Updates for MDUFMA Decision Goals and Cycle Actions: FY 04 Receipt Cohort (as of 6/30/05)

**            ****180 Day PMA Supplements with an FDA decision within 180 total FDA ****	****  days and on-time cycle actions**

|  | 3 Quarters 
FY 05 |
| --- | --- |
| # Meeting Goal | 231 |
| # Not Meeting Goal | 13 |
| # Awaiting MDUFMA Decision | Cohort
closed |
| Total in Receipt Cohort | 103 |

**FY 05 Decision**
**Target**
**80%**

** ****95%**
**231 of 244**

**Includes 99 of 103 on-time decisions**
**Includes 132 of 141 on-time cycle actions**

## KRA 1:  Performance Updates for MDUFMA   Decision Goals and Cycle Actions FY 04 Receipt Cohort (as of 6/30/05)

** ****510(k) Applications with an FDA decision within 90 total days**
** ****and on-time cycle actions**

|  | 3 Quarters FY 05 |
| --- | --- |
| # Meeting Goal | 4,450 |
| # Not Meeting Goal | 960 |
| # Awaiting MDUFMA Decision | 55 |
| Total MDUFMA Receipt Cohort | 3,326 |
| Other | 306 |
| Total | 3,632 |

**Worst Case**
**81%**
**(4,450 of 5,465)**

**FY 05 **
**Dec. Target**
**75%**

**        ****Best Case 82%**
**        ****(4,505 of 5,465)**

**Includes 2,760 of 3,271 on-time decisions**
**Includes 1,690 of 2139 on-time cycle actions**

## % IDE originals approved in first 30 day cycle

- 1B CDRH Access to Investigational Devices

**KRA 1: Public Health Promotion**

**Baseline Receipt Cohort**

**N= 224**

**Didn’t Meet**
**70%Target**

**Y**

## CDRH 1-C: % of On-time Review

**Consults, three quarters FY 05**

- _Note:_  Review consult data reported by OSB, OCER, OSEL and OC.

_**FY 05 On-Time Review Consults**_
**Expedited Review Consults = 96% (26/27)**
**Pre-IDE & IDE Review Consults = 99% (752/759) **
**Other Review Consults = 97% (1,422/1,176)**

**Met FY 05**
**Target**
**90%**

**G**

## 2A CDRH Public Health Protection    Response Rating
2A-1  16 avg. days to review death and serious injury adverse event reports, develop baseline
2A-2  134 avg. days for 14 PMI action teams to make recommendations to senior management, d
2A-4  Developing baseline for days to process recalls
2A-5  Developing baseline for days to process warning letters and untitled letters 

- 2A-1  16 avg. days to review death and serious injury adverse event reports, develop baseline
- 2A-2  134 avg. days for 14 PMI action teams to make recommendations to senior management, d
- 2A-4  Developing baseline for days to process recalls
- 2A-5  Developing baseline for days to process warning letters and untitled letters

**KRA 2: Public Health Protection**

**Y**

## KRA 2: Public Health Protection 2B CDRH Public Health Protection Resolution Rating 

## CDRH 2-C-1+2: % of Certified MQSA Facilities 

**Free of Violations, three quarters FY 05**

_**FY 05 MQSA Violation Levels**_
**Free of Most Serious Violations = 98% (3,953/4,033)**
**Free of Serious Violations = 97% (3,895/4,033) **

**Exceeded**
** ****FY 05**
**Targets**

**G**

## KRA 3:  Effective Management in Accordance with TPLC 3A CDRH Financial Accountability Index (as of June 2005 Budget Review)

** ****CDRH % of operating, payroll and cash awards dollars obligated **

**        **

_***Target ***_
_***65%-85%***_** **

**Operating**
**33%**

**Cash **
**Awards **
**59%**

**Payroll**
**68%**

**Didn’t meet**
**Operating **
**Dollar **
**Targets**
**Because **
**Of UFMS **
**transition**

## CDRH hired 130 of 152 MDUFMA hires approved for FY 03 + FY 04 (85% over two year period)
As of 6/25/05, CDRH had hired 63% (44 of 70 ) MDUFMA user fee and appropriated hires approved in FY 05 and approved in prior years but not yet on board.  Includes 8 user fee back-fills from FY 03-04.
Didn’t meet the FY 05 target of 75% because of hiring freeze

- As of 6/25/05, CDRH had hired 63% (44 of 70 ) MDUFMA user fee and appropriated hires approved in FY 05 and approved in prior years but not yet on board.  Includes 8 user fee back-fills from FY 03-04.
- Didn’t meet the FY 05 target of 75% because of hiring freeze

**3B CDRH MDUFMA Hires Percent**

**KRA 3: Effective Management **
**In Accordance with TPLC**

**Y**

## 
CDRH is executing 20 FY 05 project management plans
In the second quarter project management plan milestones were verified and updated if necessary, and there were 36 second quarter milestones
For the third quarter, standard project management plan status reported 85% (51 of 60) third quarter milestones were complete or on time

- CDRH is executing 20 FY 05 project management plans
- In the second quarter project management plan milestones were verified and updated if necessary, and there were 36 second quarter milestones
- For the third quarter, standard project management plan status reported 85% (51 of 60) third quarter milestones were complete or on time

**3C CDRH**** ****Project Management Plan Percent**
** ****of on-target milestones**

**KRA 3: Effective Management **
**In Accordance with TPLC**

**G**

## 4A CDRH Industry Meeting Number
853 Industry Business Meetings in FY 04
So far, 757 industry business meetings for 2 quarters. Since it was not reported 1st quarter, annual rate would be about 1,500/year 
4B CDRH Stakeholder Communication Level
Each Office reported progress on major projects
Over 214 web pages developed and updated
4,257 people on patient safety list serve
53,647 hits on patient safety website

- 853 Industry Business Meetings in FY 04
- So far, 757 industry business meetings for 2 quarters.** **Since it was not reported 1st quarter, annual rate would be about** **1,500/year
**4B CDRH Stakeholder Communication Level**
- Each Office reported progress on major projects
- Over 214 web pages developed and updated
- 4,257 people on patient safety list serve
- 53,647 hits on patient safety website

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**W**

## 4C CDRH Customer Survey Rating, Device Review
This year, 78% of overall close-ended responses had positive perceptions of CDRH review programs,  comparable to 79% last year   
However, last year only 4% open-ended responses thought guidance improvements were needed
This year,13% open-ended responses thought guidance improvements were needed.  Specific guidance improvements were  made  

- This year, 78% of overall close-ended responses had positive perceptions of CDRH review programs,  comparable to 79% last year
- However, last year only 4% open-ended responses thought guidance improvements were needed
- This year,13% open-ended responses thought guidance improvements were needed.  Specific guidance improvements were  made

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**G**

**Y**

## KRA 4:  Knowledge Managementand Stakeholder Collaboration

**4D CDRH Guidance Percent**

**CDRH on Target to meet both guidance goals**
**New tracking system and other improvements**

**G**

## KRA 4: Knowledge Management

- FDA recognized 695 standards for review as of end FY 04
- FDA recognized 701 standards for review as of the end of the third quarter of FY 05
- Developing baseline data to set target

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**W**

## KRA 5 Workforce Excellence

**5A-1 and 5A-3  FY 05 training hours **
**Training hours will not be reported until OCER identifies source(s) for more kinds of training hours than senior staff approved to report in FY 04**

**W**

## KRA 5 Workforce Excellence

**5A-2 Training Dollars Spent**
**In FY 04, CDRH spent $1.4M on training and travel related to training**
**That was 5% of the $28.8M operating budget**
**Senior staff approved this numerator & denominator for Center scorecard, hoping to move toward industry best practice of 10%**
**As of 7/13/05, CDRH spent $950k on training and training-related travel, about 9% of $10,456k Center operating dollars spent. However, there have been major delays spending operating dollars. **

**Y**

## KRA 5 Workforce Excellence CDRH Training Dollar Comparisons

|  | FY 04 | 3 Quarters
FY 05 |
| --- | --- | --- |
| Training 
Dollars
Obligated | $1.4M | $950k
 |
| % Operating
Dollars Obligated | 5% | 9%
 |

## KRA 5: Workforce Excellence

**5B-1CDRH External Expertise Level**:

-    External
-   Expertise
-    Dollars
-  In Millions

- External expertise investments include contracts and fellowships to supplement
- CDRH internal expertise.  It includes areas like MDFP, ORISE, MEDSUN, database
- development, web development, and software development.  It does not include basic
- services like document control, animal care, MDR contract, registration and listing,
- scanning, database maintenance, and web usability.

**KRA 5: Workforce Excellence**

**On target to exceed 10% annual target. $11M is 12% of 3****rd**** quarter Center operating + payroll**

**$13.2M**

**$13.6M:   Target=10% of Operating+ Payroll**

**G**

## KRA 5: Workforce Excellence5B-1CDRH Ext Expertise Level

**$13.6M external exp (in-**
**cludes op. and payroll)**
**$28.8M operating**
**10% $142M whole budget**

**$11M ext exp ($10M **
**Op and $1M Payroll)**
**Operating delays**
**12% whole budget**