N.H. Admin. Code § He-P 812.15

Current through Register No. 50, December 12, 2024
Section He-P 812.15 - Adverse Event Reporting
(a) Pursuant to RSA 151:37-38, the ASC administrator or designee shall report to the department the following adverse events:
(1) Serious reportable events and specifications published in the National Quality Forum's "Serious Reportable Events in Healthcare- 2011 Update" http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id=69573, available as noted in Appendix A;
(2) The exposure of a patient to a non-aerosolized blood borne pathogen by a health care worker's intentional unsafe act; and
(3) An act by a hospital or ambulatory surgery center staff with the potential to result or resulting in an infection or disease.
(b) If the licensee suspects an adverse event occurred, the ASC administrator or designee shall send a report to the department in electronic or paper format, within 15 business days after discovery of event including:
(1) ASC information;
(2) Patient information;
(3) Event information; and
(4) Type of occurrence as listed in (a) above.
(c) For events reported in (b) above the ASC shall, within 60 days, provide the department:
(1) An analysis that includes the type of harm and contributing factors; and
(2) A corrective action plan that includes what corrective actions are planned, who is responsible for implementation, when the action will be implemented and what measurements will be used to evaluate the corrective action plan or the justification for not implementing a corrective action plan if the ASC determines that one is not required.
(d) If the ASC suspects that it received a patient from a sending ASC or hospital that was subject to an adverse event, then the receiving ASC administrator or designee shall notify the sending ASC or hospital's administrator or designee and the department. The department shall inform the sending ASC or hospital that a report is required in accordance with (b) above.
(e) Upon receipt of a report of an adverse event, the department shall:
(1) Acknowledge receipt of event and review information for completeness;
(2) Review corrective action plan for system changes that reduce the risk repeat of similar adverse events;
(3) Communicate specific concerns to the ASC if the department does not find the corrective action plan credible;
(4) Track and analyze adverse events for trends, underlying system problems; and
(5) Provide information and make referrals to other state agencies as appropriate.

N.H. Admin. Code § He-P 812.15

#9727-A, eff 6-18-10

Amended by Volume XXXVIII Number 28, Filed July 12, 2018, Proposed by #12557, Effective 6/26/2018, Expires 12/24/2018.
Amended by Volume XXXIX Number 50, Filed December 12, 2019, Proposed by #12926, Effective 11/26/2019, Expires 11/26/2029.