Proposed Clinical Center Governance Model

Inaugural Meeting of the NIH Clinical Center Hospital BoardJuly 15, 2016

Lawrence A. Tabak, DDS, PhDPrincipal Deputy Director, NIH

1

Red Team Report Findings and Recommendations on Leadership

Finding Fragmented governance, responsibility, authority, and

accountability has led to an unclear locus of responsibility for leadership

Recommendation Establish an external hospital board Strengthen leadership authority and responsibility Centralize authority for clinical research Clarify responsibilities of CC leadership Integrate patient safety in individual performance plans

2

Red Team Report Findings and Recommendations on Leadership

Finding Fragmented governance, responsibility, authority, and

accountability has led to an unclear locus of responsibility for leadership

Recommendation Establish an external hospital board Strengthen leadership authority and responsibility Centralize authority for clinical research Clarify responsibilities of CC leadership Integrate patient safety in individual performance plans

3

Proposed Governance Structure

4

Clinical Practice, Safety, and Compliance

NIH Director

IC Directors

IC Scientific Directors

DDIR

NIH Steering Committee

IC Physicians, Nurses, etc.

IC Physicians, Nurses, etc.

offsite 5

IC Directors

IC Scientific Directors

Clinical Practice, Safety, and Compliance

Clinical Center CEO

Clinical Center Hospital Board

NIH Director NIH Steering Committee

DDIR

IC Physicians, Nurses, etc.

offsite 6

IC Scientific Directors

Clinical Practice, Safety, and Compliance

Clinical Center CEO

Clinical Center Hospital Board

IC Clinical Directors

IC Directors

NIH Director NIH Steering Committee

DDIR

IC Physicians, Nurses, etc.

offsite 7

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Scientific DirectorsClinical Center

COO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

Clinical Center CEO

DDIR

IC Physicians, Nurses, etc.

IC Physicians, Nurses, etc.

offsite 8

NIH Director

Clinical Center CMO

IC Directors

Clinical Center CNO

IC Scientific DirectorsClinical Center

COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

IC Clinical Directors

DDIR

IC Physicians, Nurses, etc.

IC Physicians, Nurses, etc.

offsite 9

NIH Director

IC Clinical Directors

IC Directors

Physicians, Nurses, etc. in CC Depts.

IC Scientific DirectorsClinical Center

COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

DDIR

Clinical Center CMO

Clinical Center CNO

IC Physicians, Nurses, etc.

IC Physicians, Nurses, etc.

offsite10

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

IC Scientific Directors

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

DDIR

11

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

IC Scientific Directors

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

DDIR

12

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

IC Scientific Directors

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

MEC

NIH Steering Committee

DDIR

13

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

MEC

IC Scientific Directors

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

Clinical Practice Committee

NIH Steering Committee

DDIR

14

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NIH Steering Committee

DDIR

15

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

OHSRP

DDIR

NIH Steering Committee

16

NIH Director

Clinical Center CMO

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

OHSRP

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

ORSC

IC Clinical Directors

DDIR

NIH Steering Committee

17

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

OHSRP

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

NCI Safety & Compliance

NIAID Safety & Compliance

(n) Safety & Compliance

ORSC

DDIR

NIH Steering Committee

18

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

ORSC

NCI Safety & Compliance

NIAID Safety & Compliance

(n) Safety & Compliance

Clinical Center CSO

NIH Steering Committee

OHSRP

DDIR

19

NIH Director

Clinical Center CMO

IC Clinical Directors

IC Directors

Clinical Center CNO

DDIR

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

IC Scientific Directors

Operations Clinical Center Departments

OHSRP

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Practice, Safety, and Compliance

Clinical Center Hospital Board

ORSC

NCI Safety & Compliance

NIAID Safety & Compliance

(n) Safety & Compliance

Clinical Center CSO

Resource Protocol Review

Sterile Products Request Comm

NIH Steering Committee

20

Research and Research Training

Clinical Center CMO

IC Clinical Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

Operations Clinical Center Departments

OHSRP

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Clinical Center Hospital Board

ORSC

NCI Safety & Compliance

NIAID Safety & Compliance

(n) Safety & Compliance

Resource Protocol Review

Sterile Products Request Comm

NIH Director

IC Directors DDIR

IC BSCs

Clinical Center CSO

IC Scientific Directors

CC BSC

NIH Steering Committee

21

Clinical Center CMO

IC Clinical Directors

Clinical Center CNO

IC Physicians, Nurses, etc.

Physicians, Nurses, etc. in CC

Depts.

IC Physicians, Nurses, etc.

offsite

IC Physicians, Nurses, etc.

Clinical Practice Committee MEC

Operations Clinical Center Departments

OHSRP

Clinical Center Safety &

Compliance

IC Physicians, Nurses, etc. offsite

Clinical Center COO

Clinical Center CEO

Research and Research Training

Clinical Center Hospital Board

ORSC

NCI Safety & Compliance

NIAID Safety & Compliance

(n) Safety & Compliance

Resource Protocol Review

Sterile Products Request Comm

IC BSCs

NIH Director

IC Directors DDIR

Clinical Center CSO

IC Scientific Directors

CC BSC

Clinical Research Education

NIH Steering Committee

22

Finances

NIH Director

IC Directors

Clinical Center Hospital Board

MBWG

CCGB

NIH Steering Committee

NIH Director

IC Directors DDIR

Clinical Center CSO

Clinical Center CSO

IC Physicians, Nurses, etc.

offsite 23

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