NCQA Accreditation Update

1

• NCQA Accreditation Update
• VA Day
• October 28, 2004
• Karen Jeans, MSN, CCRA, CCRN

2
The Big Question -

• What is going on?

3
Objective

• Analyze common descriptive variables of the 34
  sites that have undergone initial or renewal
  evaluation under NCQA Accreditation Standards
  Version 2.1.

4
Descriptive Analysis Questions

• What (if any) are the NCQA Elements that everyone
  is missing?
• What (if any) are the NCQA Elements that everyone
  is getting right?

5
How many sites have undergone the NCQA
accreditation survey process under Version 2.1?

• 34 VAMC Human Research Protection Programs
• 4 VAMC HRPPs - INR only
• VISN Characteristics
• 16 VISNs
• VISN 22 - 4 VAMC HRPPs
• VISNs 1, 6, 18, and 23 3 VAMC HRPPs
• VISNs 2, 4, 7, 8, 9, 11, 12, 15, 16, 17, 19, 22

6
NCQA Accreditation Status 10/04 Number of
Facilities per VISN
0
3
2
2
2
2
2
0
0
2
0
0
1
3
4
2
3
1
2
1
0
2
7

Overall Status Report Cumulative Scores

N 34 sites Mean score 90.57 Median
score 92.85 Minimum score 65.3 Maximum
score 100.0
8
Review of the NCQA Standards Version 2.1

• Four (4) Categories
• Institutional Responsibilities (INR)
• 19 Elements
• IRB Structure Operations (IRB)
• 17 Elements
• Consideration of Risks Benefits (CRB)
• 18 Elements
• Informed Consent (ICS)
• 5 Elements

9
Evaluation of the NCQA Elements (Version 2.1)

• What (if any) are the NCQA Elements that everyone
  is missing?
• Not an issue
• The question becomes What are the NCQA Elements
  that have a higher not met rate than others?
• What (if any) are the NCQA Elements that everyone
  is getting right?

10
Institutional Responsibilities (INR)

• What (if any) are the NCQA Elements that everyone
  is getting right?
• INR 1A Assurance
• INR 1D Systematic Budgeting for HRPP

11
Institutional Responsibilities (INR)

• What are the NCQA Elements that have a higher
  not met rate than others?
• INR 1B Responsible Committee or Individual
• 22 VAMC HRPPs (64.7) 100
• 4 VAMC HRPPs (11.8) 75
• 1 VAMC HRPP (2.9) 50
• 7 VAMC HRPPs (20.6) 0

12
Institutional Responsibilities (INR)

• What are the NCQA Elements that have a higher
  not met rate than others?
• INR 1C Documented Processes Complaints and
  Noncompliance
• 24 VAMC HRPPs (70.6) 100
• 9 VAMC HRPPs (26.5) 75
• 1 VAMC HRPP (2.9) 0

13
Institutional Responsibilities (INR)

• What are the NCQA Elements that have a higher
  not met rate than others?
• INR 4D Documented Processes Investigational
  Devices
• 21 VAMC HRPPs (61.8) 100
• 1 VAMC HRPP (2.9) 50
• 7 VAMC HRPPs (20.6) 0
• 5 VAMC HRPPs (14.7) NA

14
Institutional Responsibilities (INR)

• What are the NCQA Elements that have a higher
  not met rate than others?
• INR 6C Documented Processes Guidance on
  Informed Consent
• 22 VAMC HRPPs (64.7) 100
• 11 VAMC HRPPs (32.4) 75
• 1 VAMC HRPP (2.9) 50

15
Institutional Responsibilities (INR) Pharmacy
Elements

• INR 4B Investigational Drug Log
• 20 VAMC HRPPs (58.8) 100
• 5 VAMC HRPPs (14.7) 50
• 7 VAMC HRPPs (20.6) 0
• 2 VAMCs HRPPs (5.9) NA
• INR 4C Investigational Drug Dispensing
• 26 VAMC HRPPs (76.5) 100
• 6 VAMC HRPPs (17.6) 0
• 2 VAMCs HRPPs (5.9) NA

16
IRB Structure Operations (IRB)

• What (if any) are the NCQA Elements that everyone
  is getting right?
• IRB 1A IRB Membership

17
IRB Structure Operations (IRB)

• What are the NCQA Elements that have a higher
  not met rate than others?
• IRB 5D Tracking Access to IRB Records
• 52.9 of VAMC HRPPs receiving 100
• IRB 4A Documented Process Expedited Review
• 52.9 of VAMC HRPPs receiving 100
• IRB 3B Documented Process Review of Interim
  Reports and Modifications
• 64.7 of VAMC HRPPs receiving 100

18
Consideration of Risks Benefits (CRB)

• What (if any) are the NCQA Elements that everyone
  is getting right?
• CRB 2A Information on Risk

19
Consideration of Risks Benefits (CRB)

• What are the NCQA Elements that have a higher
  not met rate than others?
• Unlike other categories of INR and IRB, where
  only a few elements had less than 70 of VAMC
  HRPPs achieving a 100 score, the majority of the
  18 Elements comprising this category did not
  achieve this threshold.

20
Consideration of Risks Benefits (CRB)

• Lowest Elements
• 1. CRB 2E Documentation of Vulnerable
  Subjects
• 32.4 of VAMC HRPPs achieving 100
• 2. CRB 2C Information on Vulnerable Subjects
• 35.3 of VAMC HRPPs achieving 100
• 3. CRB 7C Consideration of Privacy
  Confidentiality
• 50.0 of VAMC HRPPs achieving 100
• 4. CRB 4B Continual Evaluation of Risks and
  Benefits
• 55.9 of VAMC HRPPs achieving 100

21
Informed Consent (ICF)

• What (if any) are the NCQA Elements that everyone
  is getting right?
• ICS Element 3A Documented Process Exceptions
  to the General Consent Requirements

22
Informed Consent (ICF)

• What are the NCQA Elements that have a higher
  not met rate than others?

23
What does all this mean?

• Four (4) Must-Pass Elements
• Issues within the Four (4) Categories
• INR Pharmacy
• IRB Documented Processes of Expedited and
  Review of Interim Reports and Modifications
• CRB IRB File Documentation
• ICS None