[No SPF Record] [IMPROVEDX] PSOs

peter.dayton at MARTINHEALTH.ORG peter.dayton at MARTINHEALTH.ORG
Fri Mar 30 20:59:35 UTC 2018


Dr Jaffe, I would submit there is a lot of concern over the role of PSOs in Florida. The amendment to our constitution in 2004 The Patient’s Right to Know Act led to a real challenge. The “privilege and confidentiality protections” afforded in the federal act have been eviscerated here in Florida. Plaintiff bar regularly subpoenas peer review and incident reporting infromation on defendants in medical malpractice cases. 

The text of the amendment reads: 

Text of Section 25: 

Patients' Right to Know About Adverse Medical Incidents 

(a) In addition to any other similar rights provided herein or by general law, patients have a right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident. 

(b) In providing such access, the identity of patients involved in the incidents shall not be disclosed, and any privacy restrictions imposed by federal law shall be maintained.

 

This has started a wave of plaintiff discovery into peer review processes, incident reporting and quality improvement activities of hospitals. Litigation over the years has unfortunately paralyzed many hospital risk management and quality departments fearing discovery of the improvement and peer review information. The response most hospital legal departments have taken is to try to shield this information by keeping it isolated in a single hospital reporting system reporting only to a PSO. The most recent Florida Supreme court decision on this, Charles v Southern Baptist Hospital of Florida,  essentially disagreed that “patient safety work product” is protected under a Federal Patient Safety and Quality Improvement Act and that the federal preemption doctrine did not apply. The standard is now that this information is discoverable in tort cases. 

 

In the Charles case , Justice Labarga wrote for the majority: 

 

“Appeal, in Southern Baptist Hospital of Florida, Inc. v. Charles, 178 So. 3d 102 (Fla. 1st DCA 2015), concluded that adverse medical incident reports requested by the Appellants pursuant to Amendment 7 in the Appellants’ medical malpractice action constituted privileged and confidential “patient safety work product,” pursuant to the Federal Act and that the Federal Act preempted Amendment 7. Id. at 108-10. We accepted this appeal under our mandatory jurisdiction of appeals from a decision of a district court of appeal “declaring invalid a state statute or a provision of the state constitution.” See art. V, § 3(b)(1), Fla. Const.2 

We disagree with the First District both as to its statutory interpretation of the Federal Act and its resulting conclusion on preemption. We hold that the Federal Act was never intended as a shield to the production of documents required by Amendment 7 and other provisions of Florida law, and Amendment 7 and other provisions of Florida law are not preempted by the Federal Act, which set up a voluntary system for hospitals to improve patient safety. Moreover, the health care provider or facility, in this case Southern Baptist Hospital of Florida (“Southern Baptist”), cannot shield documents not privileged under state law or the state constitution by virtue of its unilateral decision of where to place the documents under the voluntary reporting system created by the Federal Act.”

 

That “voluntary reporting system” is the PSO. 

 

This has crippled our efforts to have meaningful reporting, analysis and improvement. It remains to be seen if suit in federal court can provide a remedy to this dilemma. 

 

Respectfully, 

 

Peter Dayton MD

Medical Director of Patient Safety and Quality

Martin Health Systems

 

From: Bob Latino <blatino at RELIABILITY.COM> 
Sent: Tuesday, March 27, 2018 7:58 PM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
Subject: Re: [IMPROVEDX] [No SPF Record] [IMPROVEDX] PSOs

 

Thank you for the detailed description of full role of PSOs. They have been around a while now and this gives me a broader understanding of their roles.

 

Thanks

 

 

Robert J. Latino, CEO

Reliability Center, Inc.

1.800.457.0645

blatino at reliability.com <mailto:blatino at reliability.com> 

www.reliability.com <http://www.reliability.com> 

 <https://www.linkedin.com/company/958495?trk=tyah&trkInfo=clickedVertical%3Acompany%2CclickedEntityId%3A958495%2Cidx%3A1-1-1%2CtarId%3A1464096807851%2Ctas%3Areliability%20center%2C%20inc.> 

 

From: Rory Jaffe [mailto:rjaffe at chpso.org] 
Sent: Tuesday, March 27, 2018 6:49 PM
To: Society to Improve Diagnosis in Medicine <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG <mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG> >
Cc: David Meyers <dm0015 at ICLOUD.COM <mailto:dm0015 at ICLOUD.COM> >; Bob Latino <blatino at reliability.com <mailto:blatino at reliability.com> >
Subject: RE: [No SPF Record] [IMPROVEDX] PSOs

 

While that is not all PSOs were set up to do that is certainly one use. PSOs were set up to serve many needs and provide many different services.

 

To Err is Human noted that it is not human nature to share information and be completely self-critical without protections from discovery and adverse consequences (e.g., litigation, adverse publicity). The authors also noted that that must be balanced with public accountability. Among its recommendations, the publication proposed two reporting systems:

1.	Mandatory reporting of serious events to the state, for accountability
2.	Voluntary confidential reporting, for learning at the aggregate level and spread of information from individual lessons learned as well as spread of aggregate knowledge.

The publication also recommended privilege and confidentiality protection for quality improvement work product just as there is for peer review product in most states. And note that non-hospital providers in most states do not have access to peer review privilege, hampering self-critical reviews.

 

Congress rolled all this up into the law establishing PSOs. Organizations that participate with a PSO provide safety information to the PSO, and gain certain privilege and confidentiality protections (the limitations are too complex to discuss here) for the information submitted as well as the deliberations and analysis around the information. PSOs have mandated activities, many of which involve these submitted materials, including:

1.	Collection and analysis of information from providers
2.	Development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, etc.
3.	Using submitted information for encouraging a safety culture
4.	Providing feedback to participants, including assistance to minimize patient risk

 

So, PSOs do a lot of things, and it varies by PSO.

 

CHPSO, for example, collects reports of incidents, near misses, and unsafe conditions. We have about 1.6 million so far. We mine through those in several different ways—both quantitative (e.g., correlation between certain drugs and reported harm level) and qualitative (e.g., pulling a set of related events due to concerns about a potential issue that was detected either by a report by a member or by an environment scan—such as info in the MAUDE device database. We put out a newsletter, patient safety alerts, and have very frequent phone meetings (22+/year) at which our members can have a frank discussion and shared learning about a specific issue—last one was on med rec. We also provide provider-specific feedback in a number of ways.

 

CHPSO also critiques RCAs (though I hate the term Root Cause), providing feedback and disseminating lessons learned. This is at a much lower volume than incident reports for several reasons: there isn’t a standardized taxonomy for RCAs, most RCAs are documented in a way that mapping to a standard taxonomy would be tedious (not much structured data in most providers’ event analysis systems), RCAs are conducted for only a few events, and much of what we learn comes from the wider view of how systems work that we get from reading many events rather than a single RCA (again, partly because RCAs tend to look for a “root cause”, are specific to the event, and often miss the forest for the tree).

 

We also intervene at the national and international level for our members to improve the design of devices and medication packaging, as we have found that many of the safety problems are, at least in part, due to the lack of proper design of such things as EHRs, infusion pumps, etc. Manufacturers do not really respond to concerns from individual organizations, but our aggregate view helps.

 

Some PSOs are more like registries, and collect information on each patient meeting a criterion and provide aggregation and analysis for that. And others do data mining through the provider’s data systems for trends and discoveries. A number of medical specialties have formed PSOs, and some of those have a focus on diagnosis—particularly ones that serve diagnostic specialties such as pathology.

 

Rory Jaffe, MD MBA, Executive Director,  <http://www.chpso.org/> CHPSO Patient Safety Organization

1215 K Street, Suite 930
Sacramento, CA 95814
rjaffe at chpso.org <mailto:rjaffe at chpso.org> 
(916) 552-2600

 



 

Subscribe to CHPSO newsletters and announcements <https://urldefense.proofpoint.com/v1/url?u=http://eepurl.com/rNG3T&k=q2ic6PGnSSvGRm9uYENyDA%3D%3D%0A&r=1aaywgLlHZ49GLomgN2gpcNMVuk1qp9k63bo%2BqwiIHQ%3D%0A&m=nPo4DNBluQoKznFSpyRgz65%2Ffkdcc45e0bJdcK4fOdA%3D%0A&s=002145da16c17f816d8bd5309d7966b755c6462eb3621af67612bf8c116d1f8a> 

 

 

 

From: David Meyers <dm0015 at ICLOUD.COM <mailto:dm0015 at ICLOUD.COM> > 
Sent: Tuesday, March 27, 2018 7:25 AM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG <mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG> 
Subject: [No SPF Record] [IMPROVEDX] PSOs

 

From: Bob Latino <blatino at reliability.com <mailto:blatino at reliability.com> >

 

An effective RCA 'system' would incorporate such information into an RCA Knowledge base that could be used for such leveraged learning and education.  I thought the PSO's (Patient Safety Organizations) were set up to:

 

1.       create a safe haven for such sensitive RCA data (protect from discovery), and

 

2.       provide QA/QC reviews on the quality of RCA inputs and outputs, and

 

3.       construct and compile meaningful data from RCA's for the purposes of tracking and trending across the country.

 

Am I incorrect in my understanding of the role of a PSO?

 

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Moderator: David Meyers, Board Member, Society to Improve Diagnosis in Medicine


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