Passage of Senate Bill (SB) 1875, on January 1, 2001 and SB 801, on March 22, 2002 added Chapter 2.05 (commencing with Section 1339.63) to Division 2 of the Health and Safety Code. This addition requires as a condition of licensure that all general acute care hospitals, surgical clinics, and special hospitals adopt a formal plan to eliminate or substantially reduce medication-related errors. The statutory language of Health and Safety Code 1339.63 can be found at http://www.leginfo.ca.gov/calaw.html. Once at this website click "health and safety code" button and enter 1339.63 into the search box.

Health and Safety Code 1339.63 (f) revises the circumstances under which the California Department of Public Health (CDPH) conducts licensure visits and authorizes the department to monitor for implementation of each facility’s plan upon licensure visits beginning January 1, 2005.

This All Facilities Letter serves two objectives. First as notification that effective January 1, 2009, CDPH will be conducting periodic onsite licensure visits to monitor facility implementation of their CDPH approved MERP. Secondarily this letter provides an overview of the CDPH MERP survey process and guidance to assist facility preparation for a MERP survey.

The MERP survey is a new type of licensing survey for the CDPH Licensing and Certification Program. The Program is committed to developing a survey process that is meaningful, consistent with the statutory language and recognizes the complexity and sophistication associated with medication error reduction strategies. As a means to achieve this goal, the program has spent the first nine months of 2008 conducting statewide stakeholder meetings and two MERP desktop simulation surveys with four hospitals.

The following survey guidelines are the direct result of those meetings and simulation surveys, for which the Program expresses their gratitude to its hospital partners for their time, energy and expertise in helping to build a meaningful survey process.

MERP Survey Guidance 

• Facility MERP implementation date was on or before January 1, 2005 [1339.63(a)(2)]. How has your plan evolved from the implementation date to the date of the survey and why? Several stakeholders commented that facilities may be best served by conducting a "gap analysis" to reconcile the proposed MERP activities submitted to CDPH in 2002 with current activities to ensure that all 11 medication "procedures and systems" listed under 1339.63(d) are addressed.
• Implementation of technology is a required element of each MERP with some exceptions [1339.63(a)(1)]. If the technology noted in the facility submitted and CDPH approved MERP was not ultimately implemented (e.g. CPOE), the expectation is that the facility has implemented alternate technology. The process for selection of alternate technology should demonstrate how the technology, based upon independent, expert scientific advice and data, has been shown effective in eliminating or substantially reducing medication-related errors. The facility should be able to demonstrate how the implemented technology has been effective in reducing medication errors.
• Facility must evaluate, assess and address each of the 11 "procedures and systems" [1339.63(d)] to identify weakness or deficiencies that may contribute to medication errors [1339.63(e)(1)]. How was that assessment used to address system deficits to reduce medication errors? Were the implementation strategies used to address the system deficits effective in reducing medication errors?
• The MERP must be reevaluated at least annually [1339.63(e)(2)]. The evaluation should include but not be limited to assessment of each of the 11 "procedures and systems" listed under 1339.63(d). The facility may review all 11 procedures or systems at one time as part of an overall review or as individual components throughout the year.
• Upon review, the MERP will be modified when weaknesses or deficiencies are noted to achieve the reduction of medication errors [1339.63(e)(3)]. What weaknesses or deficiencies has your facility noted upon review? What actions were taken to address the deficiencies? How was the plan modified to address the noted deficiencies? Was the revised plan or the modification effective in addressing the noted deficiencies?
• The facility system or process to identify potential and actual medication errors must be proactive and include both concurrent and retrospective review of clinical care [1339.63(e)(5)]. The intent of this portion of the statute is for the facility to have a robust medication error reporting system so as to identify medication system vulnerabilities and develop corrective actions. How does your facility identify potential errors? Has the system utilized to identify errors been effective in improving medication error reporting?
• Reported medication errors are to be analyzed through a multi-disciplinary process with the objective to identify opportunities to change current procedures and systems to reduce medication errors [1339.63(e)(6)]. How does your facility analyze reported medication errors? How has this analysis been used to change current procedures or systems? What examples can you provide to demonstrate such a change in procedures or systems? Was the change in the procedure or system effective in reducing medication errors?
• There shall be a process to incorporate external medication-related error alerts to modify current process or systems as appropriate [1339.63(e)(7)]. External medication-related alerts may come from a variety of sources including but not limited to California Board of Pharmacy, Institute for Safe Medication Practice, Federal Food and Drug Administration, The Joint Commission and California Department of Public Health. What type of external alerts do you utilize for notification of medication safety issues? How have you used these alerts to modify current process or systems to promote reduction in medication errors?
• Method to assess effectiveness. The facility must have a method to assess effectiveness of both the plan and also those actions taken in accordance with execution of the plan. The method to determine "effectiveness" may be accomplished by a variety of means, such as but not limited to medication error related metrics. The method utilized should provide objective and relevant evidence that informs policy decision makers in the evaluation and development of corrective actions to effectively reduce medication errors. A question that might be asked is "how do you know that a specific action is working to reduce errors? Response to this question should be based on sound clinically relevant documentation or literature to support the response.

Survey Process

• MERP surveys are triennial, with each facility being surveyed once every three years. The first survey cycle will start January 1, 2009 and conclude December 31, 2011.
• Survey activities will be managed by the CDPH Pharmaceutical Consultant Unit and coordinated with each State and Los Angeles County District Office.
• Although surveys will be unannounced, each facility scheduled for a survey will be provided advance notice that they will be surveyed within the following 90 days. If your facility is selected, a letter will be sent advising your facility that the CDPH will be conducting a MERP survey. The facility will be directed to contact CDPH to coordinate pre-survey activities including identification of your facility liaison person with MERP responsibilities.

The collaborative method utilized to develop this new survey process has been mutually beneficial. CDPH has drawn from the expertise of its hospital partners to tailor the survey process to fit the evolving and complex medication error reduction environment unique to hospitals. Hospital partners have an enhanced understanding of the statutory mandates and increased transparency of CDPH’s projected oversight activities. Ultimately, all citizens will benefit from this partnership through improved medication use systems and reduction of medication errors.

If you have questions regarding this notification, please contact Loriann De Martini, Pharm.D., Chief Pharmaceutical Consultant at (916) 552-8645.

Sincerely,

Original Signed by Kathleen Billingsley, R.N.

Kathleen Billingsley, R.N.
Deputy Director