Transcript Hospital Regulatory Overview

California Department of
Public Health
Medication Error Reduction Plan
(MERP)
Loriann De Martini, Pharm.D.
Chief Pharmaceutical Consultant
Center for Healthcare Quality
MERP – New Hospital Survey
 Hospitals, Surgical Clinics and Special
Hospitals adopt a formal plan to eliminate or
substantially reduce medication-related
errors
– Health & Safety Code 1339.63
 Facility MERPs submitted to CDPH
(formerly CDHS) by January 1, 2002 – for
review and approval.
Medication-related Error
 “Any preventable medication-related event
that adversely affects a patient in a facility
that is related to professional practice, or
health care products, procedures, and
systems, including, but are not limited to,
…”
Health and Safety Code (H&S) 1339.63 (d)
Medication-related Error
 Prescribing
 Dispensing
 Prescription order
communication
 Distribution
 Product labeling
 Education
 Packaging and
nomenclature
 Monitoring
 Compounding
 Administration
 Use
Health and Safety (H&S) Code 1339.63(d)
MERP
Requirements
 Must include technology (e.g. CPOE)
 Implemented January 1, 2005
 Compliance with “Plan Elements” –– Added
secondary to SB 801 – emergency legislation
Plan Elements
 Lack of plan review criteria resulted in need
for emergency legislation
 Senator Speier adopted the work of an
advisory committee of stakeholders
convened by CDPH Pharmaceutical
Consultant Unit. - Issuance of an All
Facilities Letter (AFL)– 10/31/2001
 SB 801 passed 3/21/2002 – H&S Code
1339.63 (e)(1-7). In addition to
incorporation of technology each plan shall:
Plan Elements
1. Evaluate, assess, and include a method to
address each of the procedures and
systems listed under subdivision (d) to
identify weakness or deficiencies that
could contribute to errors in the
administration of medications.
2. Annual review to assess the effectiveness
of the implementation of each of the
procedures and systems listed under
subdivision (d).
Plan Elements
3. Modified as warranted when weaknesses
or deficiencies are noted to achieve the
reduction of medication errors.
4. Describe the technology to be
implemented and how it is expected to
reduce medication errors.
5. Include a system/process to proactively
identify actual or potential errors. Shall
include concurrent and retrospective
review of clinical care.
Plan Elements
6. Multidisciplinary process to regularly
analyze all identified actual or potential
errors and describe how the analysis will
be utilized to change current procedures
and systems to reduce errors.
7. Include a process to incorporate external
medication-related error alerts to modify
current processes and systems as
appropriate.
Beginning January 1, 2005, the
Department (CDPH) shall monitor
implementation of each facility’s plan
upon licensure visit.
MERP Survey Process Development
 Conducted six stakeholder meetings in collaboration
with the hospital associations
– January-June 2008
– Los Angeles, Inland Valley, Orange, San
Francisco, Sacramento and San Diego
– Objective: Understand legal elements of MERP
that dictate proposed survey process and provide
opportunity for input in the development of
MERP survey process.
– Representatives from approximately 72 hospitals
participated
MERP Survey Process Development
 Outcomes of Stakeholders Participation
– Issuance of a Survey Notification AFL –
March 28, 2008
– Conducted two “Table Top” survey
simulation exercises with four hospitals –
Los Angeles and Sacramento - September
• Representatives from 30 hospitals participated
– Issuance of a Survey Expectation AFL –
December 8, 2008
Survey Expectation AFL
 MERP implemented by 1/1/05
– How has your plan evolved?
– Current activities need to address all 11
elements
 Use of Technology
– Did you implement what you proposed?
– If not what have you done and does it
demonstrate reduction in errors?
Survey Expectation AFL
 Evaluate, assess and address each of the 11
elements to identify weakness.
– How did you use the assessment to address
system deficits?
– Where the implementations strategies
effective? And how do you know?
 MERP re-evaluated annually.
– How have you address the 11 elements on an
annual basis?
Survey Expectation AFL
 Upon review the MERP is modified when
necessary to achieve reduction of errors
– What weakness have you noted upon review?
– What actions did you take to address?
– How was the plan modified?
– Was the revised plan effective?
Survey Expectation AFL
 System to proactively identify potential and
actual errors
– How do you identify potential errors?
– Does your system promote error reporting?
– Health and Safety Code 1279.6 – Patient
Safety Plan shall include
• A reporting process that supports and
encourages a culture of safety and reporting
patient safety events.
Survey Expectation AFL
 Errors are analyzed to identify opportunities for
improvement
– What is your process for analyzing errors?
– How has prior analysis been used to change
procedures or systems?
 Process to incorporate external alerts.
– What type of alerts do you use and how?
Survey Expectation AFL
 Method to determine effectiveness.
– How do you know a specific action is
working to reduce errors?
– Response is based on sound clinically
relevant documentation or literature to
support the response
MERP Survey Process
 Surveys managed by Pharmaceutical
Consultant Unit and coordinated with
District Office and LA County.
 Surveys are Triennial
 Facilities will be provided advance notice 90 day survey window
 Opportunity to provide input on survey dates
 Forty hospitals have been noticed that they
will be surveyed between 1/12 and
6/30/2009
 Forty hospitals slated for survey third quarter
MERP Survey Process
 Request following information
– Current MERP and revisions back to 2005
– QAPI data related to medication errors for last 36
months
– P&T committee minutes and/or committees
involved in overseeing MERP – 36 mos
– Reports including metrics related to medication
error reduction – 36 mos
– Documentation of annual review of MERP since
2005
– MERP multidisciplinary team members, positions,
locations and phone numbers
Survey Process
 2002 CDPH approved MERP
 Reconcile with current facility MERP – 2005
to current
 Paper to process evaluation
MERP Survey Findings
 13 hospitals
– 23% - no deficiencies
 10 hospitals – 27 deficiencies
– 41% - Title 22
– 59% - Health and Safety Code
 Common findings
– Annual review to assess effectiveness
– Modified when weakness is identified
– Evaluate each process
– P&T committee – policy and procedures
Questions