CMS SOM App. Y, Tag Z203

adverse event and must use the analysis to affect changes in the OPO’s policies and

practices to prevent repeat incidents.

Interpretive Guidelines §486.348(c)(2)

Request the OPO’s log of all adverse events occurring over the current re-certification

cycle. Verify that the program followed its written procedures for timely investigation,

reporting and analysis and utilized the findings to effect changes in its operation as

indicated.

During the review of donor records, be alert to any adverse event incidents. Verify that

these events were investigated promptly and appropriate follow-up action was taken

including OPO policy changes, if indicated.

Transmittals Issued for this Chapter

Rev # Issue Date Subject Impl Date CR#

R180SOMA 08/24/2018 Revisions to the State Operations Manual

(SOM) Appendix Y , Organ Procurement

Organization (OPO) Interpretive Guidance

08/24/2018 N/A

R149SOM 10/09/2015 State Operations Manual (SOM) for All

Types of Providers and Suppliers Subject to

Certification

10/09/2015 N/A

R129SOM 12/05/2014 State Operations Manual (SOM) Appendix

Y- Organ Procurement Organization (OPO)

Interpretive Guidance Revisions to

§486.318 Condition: Outcome Measures

12/05/2014 N/A

R115SOM 05/23/2014 New to State Operations Manual (SOM)

Appendix Y- Organ Procurement

Organization (OPO) Interpretive Guidance

05/23/2014 N/A