A note to CPS’ participants and friends:

The Florida Supreme Court has adopted a restrictive interpretation of the PSQIA as it relates to Florida’s risk management and discovery laws.   Charles vs. Southern Baptist analyzes the relationship between the Patient Safety and Quality Improvement Act (the Act) and Florida laws that govern the development and protection of patient safety and quality material.  The Court’s opinion is available here.

Providers in Florida need to get local legal advice about the extent of the state law impact on their safety and quality work, as this is the first step in applying Charles.   Though the decision has no direct impact in other jurisdiction, it will be part of the ongoing discussion about PSO protections, so it is important to understand it. The key facts:

• Florida has very specific requirements for hospital risk management, including staff licensure and submission of certain incident reports to the state.   The statute also requires the hospital to gather information via incident reports that may not be reported to the state, but which is necessary to carry out the mandated activities.
• The discovery request specifically asked for reports prepared pursuant to parts of the statute.
• The court recognized the applicability of the Patient Safety Act and accepted that the hospital had a PSES and that the information was utilized appropriately in that context, and therefore would be protected PSWP except for the state risk management and reporting requirements.
• The court found that the need to gather the information under state law and to report some of it precluded it from being protected PSWP.

The Court held that patient safety work and the related reports, when required by state law, could not be PSWP, using the same analysis put forth by AHRQ in its Guidance last year. (AHRQ Guidance document available here.) Because the Charles information was collected or maintained for a purpose other than submission to a PSO or for dual purposes, the Court held it is excluded from the definition of PSWP contained in the PSQIA and the final rule.

This finding (that the requested information was not protected PSWP) is important when examining the next issue, whether the PSQIA pre-empts Florida Amendment 7. That provision eliminates any protection for “any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident.”  This discussion won’t delve into the detailed interaction of the PSQIA definitions and Amendment 7, though the relationship is complicated.  The important thing for PSOs and their participants in other states is the Florida Court’s somewhat gratuitous finding that the PSQIA could not supersede or pre-empt Amendment 7.

CPS doesn’t recommend that its PSO participants assume that Amendment 7 has pre-empted the PSQIA. There are several reasons why PSO participants should not view this as established doctrine (or in non-legal parlance, a “done deal”):

• The Court’s pre-emption finding may well be dicta–an opinion stated by a court that is not necessary for its decision.  Dicta can be informative, but carries little true weight as precedent.  Viewed narrowly, this is just the Florida Supreme Court stating its opinion where it doesn’t really matter.
• The Florida finding directly contravenes language in the PSQIA (Section 922): ‘‘(a) PRIVILEGE.—Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c), patient safety work product shall be privileged.”  This sets up a potential US Supreme Court appeal.  The US Supreme Court could either (1) accept the case and decide the pre-emption question or (2) find that the Florida Court’s statement was dicta and did not raise a real issue.

Applying Charles:

CPS has always advised its participants to divide their safety and quality work into 3 categories:

1. Reports that have to be submitted under state or other federal law,
2. Work that is required to be done and related documents that must be generated but not reported under state or other federal law, and
3. Work that is not required by other law.

Under Charles, documents produced to meet an independent state law requirement (Category 1) are not eligible to be PSWP. Work product that results from other state-required activities (Category 2) is in a gray zone and the answer may depend on state law and how you have structured the work.  If you have questions, contact CPS.  Review your mandatory activities and reports (bullets one and two above) and design your PSES to include work that is done outside those categories. Your PSES can always consider non-PSWP; the deliberations and analysis within the PSES can be protected, but the non-PSWP work product cannot.

There remains an open issue of admissibility in court for any of this information.  That is another fight for another day.

CPS will keep you advised of new developments.

CPS will keep you advised of new developments.

Providers, do you need a way to educate your attorneys about the benefits of a PSO? Or a refresher for your own team?

Attorneys, do you need a kickstart to understanding how the law may work in more complicated provider relationships?

Kathy Wire, Project Manager for LTC at the Center for Patient Safety, wrote an article for the PALS Advisor, the newsletter of the LTC practice group of the American Health Lawyers’ Association.  Entitled “Patient Safety Organizations: Protecting Collaborative Safety and Quality Work,” it provides an introductory explanation of the PSQIA and its potential advantages in the current collaborative healthcare climate. She also wrote a more extensive paper about the basics of PSO protection for QAPI work for the same group’s annual conference in February.  It’s available here.  While the articles are directed at a long-term care audience, the material applies to any provider.

A success story from Golden Valley Memorial Hospital, Clinton, Missouri

Indwelling urinary catheters lead to both infectious and non-infectious complications. Despite these potential harms, various studies have reported that initial catheterization was inappropriate 21% to 50% of the time and that continued catheter use was inappropriate almost half of the days that patients are catheterized.

TAKE ACTION
Four years ago Golden Valley Memorial Hospital (GVMH) took on elimination of catheter-associated urinary tract infections (CAUTI) as their rate was as high as 4.9/1000 catheter days with a catheter prevalence rate that averaged between 25-30% organization-wide and up to 39% in the ICU. While their initial CAUTI improvement team made some progress, they were unable to achieve their goal of zero infections. Determined to be successful as a member of the HRET-Hospital Engagement Network (HEN), GVMH realigned their team and joined the CUSP initiative to eliminate CAUTI’s lead by the Center for Patient Safety.

(more…)

Central line associated bloodstream infections (CLABSIs) in newborns was reduced by 58% in just 11 months.   Nine states, participating in HRET’s AHRQ-funded, NICU CUSP-CLABSI project, have reduced overall infections in newborns. The project utilized AHRQ’s Comprehensive Unit-based Safety Program (CUSP) to improve project participant’s safety culture and utilize consistent guidelines for catheter insertion and maintenance.

“The CUSP framework brings together safety culture, teamwork and best practices-a combination that is clearly working to keep these vulnerable babies safer,” says AHRQ Director Carolyn M. Clancy, M.D. “These remarkable results show us that, with the right tools and dedicated clinicians, hospital units can rapidly make care safer.”   Read the full article

In appreciation for your dedication to the On the CUSP: Stop BSI Project and to advancing the science of patient safety. Your work saves lives.
Thank you,
The Armstrong Institute for Patient Safety and Quality  

The Center and On the CUSP: Stop BSI Project participating hospitals are recognized for reducing healthcare acquired infections (HAIs) and improving the safety culture!

Work in the Missouri and Kansas city metropolitan area has saved lives and healthcare costs by reducing central line associated blood stream infections by 69% and reducing catheter-associated urinary tract infections by 30% – both efforts are exceeding national goals.

The Center, on behalf of participating hospitals, recently accepted recognition of this work from national leaders in HAI prevention, the Johns Hopkin’s Armstrong Institute for Patient Safety and Quality.   View the press release

MOCPS welcomed representatives from 10 of our CUSP/Stop CAUTI Cohort 2 teams to Columbia on September 5th, 2012, for the final Learning Session of this collaborative. We were very fortunate to have Dr. Tammy Lundstrom, CMO for Premier Health Partners in Dayton, Ohio, speak on the challenges and importance of sustainability after collaborative projects come to an end. She shared some great tips on communicating with physicians about catheter use and how to bring utilization numbers down. Teams were recognized for 100% data reporting and for reductions in their CAUTI rates.

Congratulations to:

• Bothwell Regional Health Center
• Callaway Community Hospital
• Citizens Memorial Hospital
• Cooper County Memorial Hospital
• Cox Medical Centers
• Cushing Memorial Hospital
• Jefferson Regional Medical Center
• Liberty Hospital
• Mercy Washington
• Missouri Southern Healthcare
• Ozarks Medical Center
• Saint Joseph Medical Center
• Saint Lukes Hospital of Kansas City
• Saint Lukes South Hospital
• The University of Kansas Hospital

This new report from the Commonwealth Fund offers lessons from hospitals that have not experienced any central line associated blood stream infections in their ICUs in 2009.   These lessons include following evidenced based protocols, importance of a dedicated team overseeing central line insertions, value of participation in national and statewide collaborative, and the need for continued monitoring of infection rates and maintaining communication with staff about rates and goal achievement.

The Kansas Healthcare Collaborative, along with the Missouri Center for Patient Safety, co-hosted the Cohort 5 & 6 CUSP/Stop CLABSI Mid-Course meetings in Topeka, Kansas this week!   Over 30 teams from Kansas and Missouri were in attendance and participated in group work on overcoming project barriers and walked through the process of learning from a defect.

Several Missouri teams were recognized for completing 6 or more consecutive months without a CLABSI in 2011, and teams from Cohort 2 in the Greater Kansas City area were recognized for completing the two year project.   Congratulations to all the Missouri teams!