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Status

APPROVED

e-Vote Close Date

 

Affirm-Negative-Abstain7-1-1
Date Approved

 

Work GroupPublic Health
Project Insight ID1655
Work Groups that submitted votes

Anesthesia

Clinical Genomics

CIC

CQI

Emergency Care

LHS

Pharmacy

Work Groups that did not submit votes

BR&R

CBCP

CDS

Devices

Patient Care

Public Health



  • For each Work Group, choose Affirmative, Negative, Abstain

  • If you are voting for a WG AND are also a co-chair for another WG in the CSD, please include a comment to indicate which WG you are voting on behalf of.

  • Use the  in the comments section to add comments to the vote.

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  • Negatives that do NOT have a comment will be considered abstain. Please register your vote below.

PSS: NHSN Adverse Drug Event - Hypoglycemia Report


Project Approval Request

Choices Your Vote Current Result: (7 Total Votes) Comments
abstain Project Approval Request
1 Votes , 14%
affirmative: Given the clinical content of this IG and the focus on hypoglycemia, nutritionists and nutrition services should be called out specifically among providers listed in the PSS.   voting for LHS
affirmative: Anesthesia
affirmative: Lindsey Hoggle voting for CIC
affirmative Project Approval Request
5 Votes , 71%
negative (with Comment only) Project Approval Request
1 Votes , 14%



*  Refer to Can I add comments without editing the page? for directions.

9 Comments

  1. Given the clinical content of this IG and the focus on hypoglycemia, nutritionists and nutrition services should be called out specifically among providers listed in the PSS.  

    voting for LHS

    1. Response from Project Team: Response: Thank you for this important point; we agree wholeheartedly with it given the role nutritional interruption plays in contributing to hospital-associated hypoglycemia. We have updated the PSS (section 6h) to reflect this omission.

  2. This is redundant, we already report ADE through the FDA sentinel network. Just use that.

    1. Response from Project Team: 

      Response: There are several ways in which ADEs that would be reported through NHSN are distinct from those reported through the FDA Sentinel Initiative (SI), thus requiring a new IG. Adverse drug event reporting through CDC NHSN and through FDA SI serve fundamentally different purposes, support different public health questions, and utilize different data sources. This is reflected in this newly proposed PSS. NHSN plans to collect information on well-recognized ADEs from commonly used medications in U.S. hospitals to directly inform local (hospital-level) quality improvement (e.g., https://www.cdc.gov/nhsn/datastat/index.html) and benchmarking for one the most common iatrogenic harms in U.S. hospitals. In contrast, FDA SI is primarily focused on novel, previously unrecognized , under-studied, or rare ADEs that are informed by large dataset analysis (primarily administrative claims data), to inform nationwide regulatory decision-making--not local/hospital quality improvement. The PSS describes the intent for hospitals to report individual, patient-level blood glucose values drawn during a hospitalization and linked to a hospital medication administration event. These type of data are not traditionally available via FDA SI. The ADE data for NHSN are based on EHR (laboratory and eMAR) sources. The ADE data from FDA SI are traditionally based on administrative claims sources. The IG would reflect requirements that could ensure data can be calculated to generate local quality improvement metrics for hospitals and a proposed Centers for Medicare & Medicaid Services electronic clinical quality measure (eCQM), https://cmit.cms.gov/CMIT_public/ViewMeasure?MeasureId=6086, which would not be feasible using FDA SI ADE reporting standards.


      1. Thank you for the clarification

  3. Per James McClay comment, this is specifically focused on a narrow use case regarding hypoglycemia as an adverse event during a hospitalization (as I understand it). It does seem directly related to some clinical quality measures which are now being evaluated as electronic clinical quality measures (eCQMs). Perhaps it will be helpful to indicate the difference between these requirements for the IG and how they complement the FDA ADE sentinel network (assuming the do complement it). Happy to change vote to affirmative if there is evidence of alignment in the project proposal.

    1. Response from Project Team: Response: We appreciate the insight regarding alignment with eCQM as this was an important consideration for how the proposed NHSN ADE measures were constructed. A new IG would ensure that the data reported could be used to calculate the eCQM should the measure be incorporated into future hospital quality reporting/performance programs. We have responded to Dr McClay’s comments above regarding the need for a new IG and are happy to provide additional information to address any remaining concerns.

      1. Thank you for the response. Will update my vote to affirmative.

  4. Response received from CQI and vote changed. No additional feedback to project team responses received from other WGs by end of day December 9th.  Forwarding to the TSC for approval.