The Virginia Hospital & Healthcare Association submits these public comments in response to the Virginia Board of Pharmacy regulation at 18 VAC110-20, published in the Virginia Register, Volume: 30 Issue: 6, starting at page 753.  The definition of “actively reports” should be modified to be consistent with federal regulations promulgated under the Patient Safety and Quality Improvement Act of 2005 (Pub. L. 109-41) (the “Act”).  The Board of Pharmacy defines “actively reports” to mean “reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical or at least within 30 days of identifying the error.”  However, the Agency for Healthcare Research and Quality regulations do not require information to be reported to a PSO in order to qualify for protections under the Act nor do they specify a timeframe for reporting patient safety work product.  In issuing final regulations under the Act, AHRQ clarified that “information documented as collected within a patient safety evaluation system by a provider shall be protected as patient safety work product” and “would become patient safety work product upon collection.”  See 73 Fed. Reg. 70741.  Accordingly, federal regulations do not require reporting in order for information to be protected as patient safety work product.  There are several reasons why a provider would not report patient safety work product to a PSO within (30) days and the flexibility in the federal regulations was designed, in part, to avoid unintended consequences associated with a “race to report” and the need to develop dual systems for handling patient safety information.  Id.  Under the federal regulations, the act of documenting and collecting the information is sufficient.

One possible solution to address the apparent discrepancy between the Board’s proposed regulations and the federal regulations would be to change the definition of “actively reports” to mean “documenting as collected for reporting all dispensing errors and analyses of such errors to a patient safety organization as soon as practical or at least within 30 days of identifying the error.”  This approach balances the need to encourage a timely process for identifying and analyzing errors with the need to extend the reporting timeframe beyond 30 days and is consistent with the federal regulations.

Thank you for this opportunity to comment.  Please contact R. Brent Rawlings with any questions regarding these public comments by calling (804) 965-1228 or by email at brawlings@vhha.com.