1 
 
U.S. Department of Health and Human Services 
Office of Inspector General 
 
 
Patient Safety 
Organizations: 
Hospital 
Participation, 
Value, and 
Challenges  
OEI-01-17-00420  Suzanne Murrin 
September 2019  Deputy Inspector General  
  for Evaluation and Inspections 
 
oig.hhs.gov   
1   Report in Brief  U.S. Department of Health and Human Services 
September 2019 
Office  of Inspector General 
OEI-01-17-00420 
 
 
Patient Safety Organizations: Hospital   
Why OIG Did This Review 
Participation, Value, and Challenges 
Researchers have estimated that over 
The Agency for Healthcare Research and  200,000 people die each year because 
Qualitys (AHRQs) voluntary Patient Safety  Key Takeaway  of medical errors in hospitals.  
Organization (PSO) program is the first and  Many hospitals that  Learning from those and other, 
only nationwide program that offers legal  participate in the Patient  nonfatal events to improve patient 
protections for providers to disclose and  Safety Organization program  safety is the goal of the PSO program.  
learn from patient safety events.  An  find that it has improved  Hospitals descriptions of their 
organization must meet AHRQs criteria to  patient safety.  However,  experiences with the program provide 
be federally listed as a PSO.  The program is  challenges have slowed  insight into the programs progress 
also the only program to establish a  progress toward a national  toward facilitating national learning 
Network of Patient Safety Databases (NPSD)  system of learning to  from patient safety events.  This 
to enable learning on a national scale about  improve patient safety.   review is the first to explore the extent 
the causes of such events.  to which hospitals participate in the 
  PSO program and their perspectives 
What OIG Found  on its values and challenges.  It builds 
on previous Office of Inspector 
Over half of general acute-care hospitals work with a PSO, and nearly all of them 
General work from 2010 that found 
find it valuable.  Among hospitals that work with a PSO, 80 percent find that 
27 percent of hospitalized Medicare 
the PSOs feedback and analysis on patient safety events have helped prevent 
future patient safety events.   beneficiaries experienced harm 
because of medical care.  OIG 
However, the PSO program faces challenges.  Hospitals that do not participate 
recommended, among other things, 
do not perceive the PSO program to be distinct from other patient safety 
that AHRQ encourage hospitals to 
efforts.  Nearly all of these hospitals cited redundancy relative to other patient 
participate in the PSO program.   
safety efforts as a reason they do not participate.  Uncertainty over the 
programs legal protections and determining what information is protected can  How OIG Did This Review 
be challenging for hospitals.  This may discourage them from disclosing data to 
We selected a random sample of 
their respective PSOs or participating at all.  Although the Common Formats 
600 general acute-care hospitals to 
(standard methods for reporting patient safety data) enable AHRQ to 
survey and achieved a 79-percent 
aggregate and analyze data, requiring them for the NPSD may slow its 
response rate.  We asked them 
progress.  Forty-two percent (31 of 74) of PSOs cannot contribute to the NPSD 
detailed questions about their 
because they do not use the Common Formats.  Challenges with the Common 
experiences in working with federally 
Formats reflect the limits of using a standardized approach to capturing patient 
listed PSOs and their perceived value 
safety data.  Finally, AHRQ provides technical assistance that PSOs find helpful, 
of the program.  We also surveyed all 
but its guidance falls short of meeting PSOs needs.  
federally listed PSOs, achieving 
What OIG Recommends  a 90-percent response rate.  We 
asked them detailed questions about 
AHRQ should do more to support and promote the PSO program.  Specifically, 
their experiences in working with 
the Office of Inspector General recommends that AHRQ (1) develop and 
hospitals and with AHRQ.  Finally, we 
execute a communications strategy to increase nonparticipating hospitals 
interviewed AHRQ staff and reviewed 
awareness of the PSO program and the programs value to participants; (2) take 
data on AHRQs oversight of the 
steps to encourage PSOs to participate in the NPSD, including accepting data 
program from 2009 through 2017. 
into the NPSD in other formats in addition to the Common Formats; and 
(3) update guidance for PSOs on processes for listing PSOs.  AHRQ concurred 
with our first and third recommendations and partially concurred with our 
second recommendation. 
Full report can be found at oig.hhs.gov/oei/reports/oei-01-17-00420.asp   
TABLE OF CONTENTS 
BACKGROUND  1 
Methodology  6 
Key Characteristics of the PSO Program  9 
   
FINDINGS   
Over half of hospitals work with a PSO, and nearly all of them find the relationship valuable  10 
Hospitals that do not participate in the program do not perceive it to be distinct from other           11 
patient safety efforts 
 
Uncertainty over the programs legal protections and determining what information is  12 
protected can be challenging for hospitals 
Although the Common Formats enable AHRQ to aggregate and analyze data, requiring them  13 
for the NPSD may slow its progress 
AHRQ provides technical assistance that PSOs find helpful, but its guidance on the program  15 
falls short of meeting PSOs needs 
   
CONCLUSION AND RECOMMENDATIONS  16 
AHRQ should develop and execute a communications strategy to increase hospitals  16 
awareness of the program and its value to participants 
AHRQ should take steps to encourage PSOs to participate in the NPSD, including  17 
accepting data into the NPSD in other formats in addition to the Common Formats 
AHRQ should update guidance for PSOs on the initial and continued listing processes   18 
   
AGENCY COMMENTS AND OIG RESPONSE    19 
 
APPENDICES   
Appendix A: Statistics for Responses to Select Items From Surveys   20 
Appendix B: Agency Comments  32 
   
ACKNOWLEDGMENTS  37 
ENDNOTES  38 
   
BACKGROUND 
 
Objectives 
 
1.  To determine the extent to which hospitals participate in the PSO 
  program. 
2.  To describe hospital perspectives on the value of the PSO program. 
 
3.  To describe challenges to the PSO program. 
4.  To assess the Agency for Healthcare Research and Qualitys 
oversight of the PSO program. 
 
Researchers have estimated that over 200,000 people die each year because 
of medical errors in hospitals. 1  The aim of the Patient Safety and Quality 
Improvement Act of 2005 (the Patient Safety Act, or the Act) is to improve 
patient safety by encouraging learning from these and other, nonfatal 
events.2  The Act created the Patient Safety Organization (PSO) program 
and established PSOs to collect, aggregate, and analyze patient safety 
information submitted by providers.  All aspects of participation in the PSO 
program are voluntary.3  To address providers fears that such information 
would be used against them, the Act also established the first and only 
comprehensive, nationwide confidentiality and privilege protections 
(hereinafter, legal protections) for certain patient safety information that 
providers submit to PSOs.4  The Act also requires a national Network of 
Patient Safety Databases (NPSD) to aggregate and analyze nonidentifiable 
patient safety data and make it available for researchers. 5  The Institute of 
Medicinenow the Health and Medicine Division of the National 
Academiescalled for such a reporting and learning system in its landmark 
1999 report To Err Is Human: Building a Safer Health System.6   
In 2010, the Office of Inspector General (OIG) found that 27 percent of 
hospitalized Medicare beneficiaries experienced harm because of medical 
care.7  In that report we recommended that the Agency for Healthcare 
Research and Quality (AHRQ) should, among other activities, enhance its 
efforts to identify adverse events, in part by continuing to encourage 
hospitals to participate in the Patient Safety Organization (PSO) program. 
This study examines the extent to which hospitals have participated in and 
received value from the PSO program; identifies challenges associated with 
it; and assesses AHRQs oversight of the program.  It contributes to OIGs 
body of work on patient safety.  
 
The PSO Program  In 2006, the Secretary of Health and Human Services delegated most 
authorities under the Patient Safety Act to AHRQ.  The Secretary delegated 
the responsibility for interpreting and enforcing the legal protections of the 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  1 
OEI-01-17-00420   
Patient Safety Act to the Office for Civil Rights (OCR).8  In 2008, the 
Department of Health and Human Services (HHS) published a final rule 
implementing the Act.9 
Patient Safety Organizations 
Central to the PSO program are organizations that meet AHRQs 
requirements to be federally listed as PSOs.  PSOs are private 
organizationswhich may be consulting firms, health care providers, or 
other entitiesthat serve as patient safety experts for health care providers 
that choose to work with them (hereinafter referred to as PSOs members).10,  
PSOs may be nonprofit or for-profit.  A PSOs members may also choose to 
disclose information about patient safety events and other patient safety 
information to the PSO. 
A PSO is required to perform certain patient safety activities to be federally 
listed as a PSO.  These activities include, but are not limited to, efforts to 
improve patient safety and the quality of health care delivery; the collection 
and analysis of Patient Safety Work Product (PSWP), which we discuss in 
more detail below; and procedures to preserve the confidentiality of PSWP.   
PSOs may perform these activities in various ways, such as analyzing data to 
identify the causes of patient safety events; developing recommendations to 
prevent future events and improve patient safety; and facilitating the 
sharing of best practices among providers to enhance learning.11  As of 
July 2019, 83 organizations were listed with AHRQ as federally listed PSOs. 
Patient Safety Work Product and Its Legal Protections  
The Patient Safety Act established legal protections for certain 
informationwhen it meets the definition of PSWPthat providers disclose 
to PSOs.12  In general, the Act defines PSWP as including any data, reports, 
records, memoranda, analysis, or statements that are assembled or 
developed by a provider for reporting to a PSO and are reported to a PSO; 
or are developed by a PSO for conducting patient safety activities.13  The Act 
also excludes medical records, among other records, from the definition of 
PSWP.   
PSWP is not generally subject to subpoena or discovery in criminal, civil, or 
administrative proceedings, including disciplinary action against 
a provider.14, 15  Additionally, PSWP is not subject to disclosure under the 
Freedom of Information Act.16  According to HHS, these protections alleviate 
concerns about such information being used against a provider, such as in 
litigation.17   
Network of Patient Safety Databases 
The Patient Safety Act directed the Secretary of HHS to develop the NPSD 
to enable national learning about patient safety events.  According to the 
Act, the NPSD should have the capacity to accept, aggregate, and analyze 
other entities.18  AHRQ and others are to use the NPSD data to analyze 
national and regional statistics, including trends and patterns of health care 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  2 
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errors.19  AHRQ is to report on the findings from this analysis.20  
An intermediary known as the PSO Privacy Protection Center (PSOPPC) 
renders data nonidentifiable before it reaches the NPSD (see Exhibit 1).  
A contractor operates both the PSOPPC and the NPSD for AHRQ.   
In a 2010 report, the Government Accountability Office found that AHRQ 
was in the process of developing the NPSD and expected it to be ready to 
receive data from hospitals by February 2011.21  The PSOPPC, which renders 
data nonidentifiable, was ready to receive data in 2012.  In 2017, AHRQ told 
us that although some PSOs had submitted data, the PSOPPC had not yet 
released data to the NPSD because its process for rendering data 
nonidentifiable limited the utility of the data.  Furthermore, AHRQ also 
noted that the process may limit the quantity of data that could be made 
available to the public.  The PSOPPC tested methods for preparing data for 
the NPSD, and AHRQ launched the public-facing NPSD website on June 21, 
2019.  
 
Exhibit 1.  PSWP flows from providers and PSOs to the NPSD. 
 
   
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Common Formats 
As permitted by the Patient Safety Act, AHRQ developed common 
definitions and formatsknown as the Common Formatsfor reporting 
patient safety event data.  It did so in collaboration with the National Quality 
Forum and with input from stakeholders including PSOs and providers.  The 
Common Formats make it possible for AHRQ and others to aggregate and 
analyze patient safety event data.  As of 2019, AHRQ has released Common 
Formats for reporting events that occur in three settings of care: acute-care 
hospitals, community pharmacies, and skilled nursing facilities.  AHRQ 
continues to develop new versions of the Common Formats. 
PSOs are not required to use the Common Formats.  However, although 
PSOs may collect data in any standardized format that permits valid 
comparisons of similar cases among similar providers, the NPSD accepts 
only data in the Common Formats.  Federally listed PSOs must use either 
the Common Formats or an alternative system of formats and definitions, 
or provide a clear explanation why it is not practical or appropriate to do 
either.22 
 
AHRQ Oversight of  PSO Listing and Certification 
The Patient Safety Act directed the Secretary of HHS to compile and 
the PSO Program 
maintain a list of PSOs.  Accordingly, an entity wishing to be listed as a PSO 
must submit a certification to AHRQ attesting that it has policies and 
procedures in place to perform the patient safety activities described in the 
Act.  It must also attest to meeting additional criteria described in the Act, 
which include having a qualified workforce, not being a health insurer, and 
having at least two bona fide contracts with providers every 2 years.23  
AHRQ reviews and verifies the certification and ensures that the entity 
understands the implications of becoming a PSO.  If AHRQ accepts the 
entitys certifications, AHRQ will list the entity as a PSO.24 
After its initial certification, a PSO must recertify with AHRQ every 3 years.25  
AHRQ calls its review of a PSOs recertification a continued listing review 
(see Exhibit 2 on the next page).  AHRQ may also conduct an announced or 
unannounced compliance review of a PSO to verify compliance with the Act 
and the final rule that implemented the Act.  If AHRQ finds that a PSO is not 
in compliance, AHRQ may file a notice of preliminary finding of deficiency 
with the PSO, requiring it to remedy the specified deficiencies. 
   
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Exhibit 2.  AHRQ performed its oversight responsibilities as set forth in the 
Patient Safety Act.26 
 
AHRQ is also responsible for delisting PSOs that do not meet requirements 
of the Act.  Delisting refers to the loss of a PSOs federally listed status, and 
AHRQ may delist a PSO for three reasons: the PSO voluntarily relinquishes 
its status as a PSO; the PSOs listing expires; or AHRQ revokes the PSOs 
listing for cause.  AHRQ may revoke a PSOs listing for cause if the PSO fails 
to correct a deficiency.27 
Technical Assistance 
The Patient Safety Act authorized the Secretary of HHS to provide technical 
assistance to [PSOs], including convening annual meetings for [PSOs] to 
discuss methodology, communication, data collection, or privacy 
concerns.28  Accordingly, AHRQ hosts an annual meeting for PSOs.  Topics 
at the 2018 meeting included sessions in which PSOs shared successful 
practices and discussions on how AHRQ could improve and support the 
PSO program.  AHRQ also provides technical assistance by responding to 
inquiries from PSOs and making resources available on its website.29 
 
Litigation Regarding  The legal protections for PSWP have been tested through the courts, with 
varied outcomes.  For example, in 2012, an Illinois appellate court affirmed 
the Acts Legal 
a trial courts decision that pharmacy incident reports constituted PSWP and 
Protections for 
were protected under the Act.30  However, since this case, some State courts 
PSWP  have found that the Act does not protect certain information.  In 2014, the 
Kentucky Supreme Court held that adverse event reports created to comply 
with State laws are not protected. 31 The Florida Supreme Court came to 
a similar conclusion in 2017. 32  The U.S. Supreme Court denied petitions to 
review both the Kentucky and Florida cases. 33, 34  
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In 2016, the Kentucky Supreme Court heard another case on the scope of 
the privileges provided by the Act.  It ruled that documents collected, 
maintained, or developed for the sole purpose of reporting to a PSO are 
privileged.  The Court also clarified that providers may store information in 
their respective patient-safety evaluation systems but that doing so does 
not relieve providers from their State and Federal reporting requirements.35 
Such cases spurred debate among stakeholders over what constitutes 
PSWP.  In 2016, HHS issued guidance to clarify the definition, stating that 
information prepared for purposes other than reporting to a PSO is not 
PSWP.36  HHSs guidance did not settle the uncertainty over PSWP for 
some.  Providers may be reluctant to disclose data that they are uncertain 
will meet the definition of PSWP and be protected in the State and Federal 
courts.  
 
Methodology  Scope 
This report is based on the results of surveys that we sent to all PSOs listed 
with AHRQ as of April 2018 and to a nationally representative sample of 
general acute-care hospitals that participated with Medicare as of 
February 2018.  Our findings on the PSOs characteristics, services, and their 
interactions with AHRQ encompass all PSOs that responded to our survey.  
Our findings on PSOs experiences working with hospitals reflect only those 
PSOs that identified themselves as working with hospitals.  Our findings on 
AHRQs oversight considered the agencys activities from 2008 through 
2017.  
 
Data Sources and Analysis 
To conduct this study, we relied on multiple data sources. 
PSO Survey 
We sent an electronic survey to all 82 PSOs listed on the AHRQ website at 
the time of our survey.  PSOs could respond to the survey from May 1, 2018, 
through June 15, 2018; 74 PSOs responded, a 90-percent response rate.  The 
survey included questions related to PSO characteristics, services PSOs offer, 
and challenges PSOs face. 
Hospital Survey 
We selected a nationally representative, simple random sample of 
600 general acute-care hospitals to ask about their experiences with 
federally listed PSOs.  We selected the random sample from among all 
3,400 general acute-care hospitals that participated in Medicare in 2018.  Of 
the original 600 hospitals in our sample, we found that 2 were closed, 
bringing our total sample of eligible hospitals to 598. 
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We sent an electronic survey to the sampled hospitals between May 16, 
2018, and July 23, 2018; 474 hospitals responded, a 79-percent response 
rate.  We requested information on whether hospitals work with a federally 
listed PSO; why they did or did not; and what value and challenges they 
perceive from the PSO program if they do. 
AHRQ Data 
We requested data from AHRQ on its oversight of the PSO program from 
its start through 2017, including the following: the numbers of initial and 
continued PSO listings; the number of delisted PSOs and related 
information; the number and outcomes of compliance reviews; and the 
number of times that AHRQ provided technical assistance to PSOs, and the 
nature of that technical assistance. 
Stakeholder Interviews 
We conducted interviews with staff from a purposive sample of 9 hospitals 
and 12 PSOs.  We use the data from these interviews as examples and to 
provide context, but do not use them to generalize to all hospitals or PSOs.  
We also interviewed AHRQ staff and others, including an attorney who 
works with PSOs and a representative from a professional association for 
PSOs. 
Analysis 
We analyzed data from our PSO survey to describe PSOs characteristics, 
services offered, and experiences working with AHRQ.  We also analyzed 
data from that survey to describe the subset of PSOs that work with 
hospitals.  We produced estimates from our hospital survey data to describe 
the experiences of general acute-care hospitals with listed PSOs.  
Some questions on our surveys offered response options on a 3-point or 
4-point ranked scale.  For example, for some questions, respondents could 
choose very important, somewhat important, slightly important, or not 
important. For others, they could choose from major challenge, minor 
challenge, or not a challenge.  We report our findings by aggregating all 
categories that positively identify something either as challenging or as 
important, for example.  
Finally, we used data from our interviews with hospitals and PSOs to add 
context to our survey data and to gain additional detail on areas of interest 
that PSOs and hospitals identified. 
 
Limitations 
We did not independently verify the survey responses that PSOs and 
hospitals provided, nor did we independently verify the data that AHRQ 
provided on its oversight activities. 
Data from the PSO survey represent the views and experiences of the 
74 responding PSOs rather than all 82 PSOs.   
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In addition, because we limited the scope of our evaluation of the value of 
the PSO program to general acute-care hospitals participating in Medicare, 
this study does not reflect the experiences of other types of providers that 
work with PSOs. 
Standards  We conducted this study in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General on 
Integrity and Efficiency. 
   
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Key Characteristics of the PSO Program 
Not all PSOs are the same.  Although they generally offer a similar array of services, they differ in other 
ways.  For example, PSOs vary by size, profit status, and specialty.   
 
Exhibit 3.  PSOs by the Numbers 
 
 
   
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FINDINGS 
Fifty-nine percent of general acute-care hospitals participating in Medicare 
Over half of 
work with a PSO.  More than two-thirds of those hospitals (68 percent) have 
hospitals work with 
done so for 5 years or fewer.  Among the most important reasons why 
a PSO, and nearly all  hospitals choose to work with a PSO are the opportunity to improve patient 
of them find the  safety (with 94 percent of hospitals citing it as very important in their 
decision to work with a PSO); the opportunity to learn from PSOs analysis 
relationship 
of patient safety data (with 87 percent citing it as very important), and the 
valuable 
privilege and confidentiality protections for PSWP (with 83 percent citing 
this reason as very important). 
Among hospitals that work with a PSO, nearly all (97 percent) find it 
valuable to work with a PSO and half rate it as very valuable. 
Hospitals find that working with a PSO improved patient safety 
Among hospitals that work with PSOs, 80 percent find that feedback and 
analysis on patient safety events have helped prevent future events, and 
72 percent find that such feedback has helped 
them understand the causes of events.  For 
80% 
example, one hospital told us that its PSO 
alerted its members about a malfunction with 
a certain medical device.  This hospital was able 
of hospitals that  to identify the device and resolve the 
work with a PSO  malfunction.  Although it can be difficult to 
found that the PSO's  identify events and quantify improvement, 
63 percent of hospitals that work with PSOs 
feedback and 
believe that feedback and analysis from a PSO 
analysis was helpful 
has made a measurable improvement in patient 
to prevent future 
safety.37   
patient safety events 
PSOs offer hospitals analysis and feedback of 
patient safety in several ways, including root-cause analyses of specific 
events and analysis of data aggregated from their members.  A PSO may 
use its analysis of aggregate data to show members how their data 
compare to those of their peers; this service is known as benchmarking.  
Among hospitals that receive a benchmarking service, nearly all (96 percent) 
find it helpful. 
Hospitals find PSO services related to knowledge-sharing and 
learning to be helpful 
Among hospitals who say working with a PSO has been very valuable, 
nearly half volunteered that the value is in the ability to learn from other 
organizations.  Working with a PSO allows hospitals to draw on the shared 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  10 
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knowledge of their fellow member-hospitals through peer-to-peer learning 
that would not otherwise be available to them.   
A service called safe tables is 
One Hospitals Perspective 
one example of how PSOs 
facilitate peer-to-peer learning 
Learning from other organizations in a 
in a confidential environment.  
safe environment has been extremely 
PSOs use safe tables to bring 
helpful.  It assists us with identifying 
together staff from their 
risks we may not have considered and 
provider memberseither in 
decreases the chance of a harm 
person or virtuallyto discuss 
occurring to our patients... 
patient safety topics, such as 
adverse events that have 
occurred at member institutions.  PSO staff facilitate the meetings, which 
may include analysis of the causes of adverse events and possible solutions 
for preventing them in the future.   
Both hospitals and PSOs find that safe tables are a valuable service.  One 
PSO said that safe tables are among the most valuable services it offers, 
noting that its membership had quadrupled since it began offering them: 
[E]ven though [providers] are hesitant to submit adverse events [to PSOs], 
they will talk in a protected environment.  A physician we interviewed called 
safe tables priceless, and noted that such discussions can change 
a hospitals culture.  Nearly all (95 percent) hospitals that work with a PSO 
found that their PSOs have helped improve the culture of safety at their 
facilities.  A culture of safety is one that (among other key features) enables 
individuals to report errors without fear of reprimand and to collaborate on 
solutions.38   
 
For hospitals that do not participate in the PSO program, a perception that 
Hospitals that do 
the program is redundant relative to other patient safety efforts is 
not participate in 
an important factor for 97 percent of such hospitals and a very important 
the program do not 
factor for 70 percent.  For example, most hospitals that do not work with 
perceive it to be  a PSO are working with a non-PSO entity (79 percent) to improve patient 
safety.  Similarly, most (82 percent) believe that a PSOs functions are 
distinct from other 
redundant to their internal efforts to improve patient safety.  
patient safety 
Furthermore, hospitals perceive PSO reporting 
efforts 
97%  as being redundant to Federal and State 
  reporting of patient safety data.  Although the 
data that hospitals send to PSOs may be 
similar to what they send to these reporting 
of hospitals that do 
systems, reporting to a PSO does not exempt 
not work with a PSO 
them from government reporting 
said redundancy was  requirements.  About 80 percent of hospitals 
an important factor  that do not work with a PSO cite Federal or 
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State redundancies in reporting as a factor in that decision.  
Perceived redundancies in reporting and overlap with other patient safety 
programs may foster the impression that a PSO creates extra work, 
detracting from the value that hospitals perceive in working with a PSO.  
In fact, workload is an important 
factor for 87 percent of  One PSOs Perspective 
hospitals that do not participate 
Because the PSO program overlaps 
in the program.  Perceived lack 
with other initiatives... it can be 
of value is also an important 
challenging to recruit and engage 
factor in the decision not to 
members who have limited time and 
work with a PSO for about 
resources. 
two-thirds (67 percent) of the 
hospitals that do not participate.  These perceptions may help explain why 
some PSOs fail to recruit even two providersthe minimum required by 
the Actand relinquish their listing as a result. 
Finally, among hospitals that do not work with a PSO, lack of familiarity with 
the program was a factor for almost two-thirds (61 percent).  Some hospitals 
volunteered that they wanted to learn more about the program. 
 
Uncertainty over the  The Act enables the PSO program to offer legal protections for certain 
patient safety data that other programs cannot.  AHRQs website includes 
programs legal 
resources for understanding those protections.  However, despite these 
protections and 
available resources, uncertainty over the Acts legal protections for PSWP is 
determining what  a challenge for 27 percent of hospitals that work with a PSO, and a major 
challenge for 24 percent.  
information is 
protected can be  Concern over the protections may be heightened for providers in States 
where such protections have been challenged in court.  For example, one 
challenging for 
PSO told us that some hospitals in Florida, where protections have been 
hospitals 
challenged in court, do not report patient safety information because of 
their uncertainty over legal protections.   
A clear understanding of the Patient Safety Acts definitions is vital, because 
the legal protections apply only to information that meets the definition of 
PSWP.  Fifty-seven percent of hospitals that work with PSOs found 
determining what constitutes PSWP to be a challenge; however, 43 percent 
did not find it challenging.  Similarly, 56 percent of hospitals that work with 
PSOs find interpreting HHS guidance on the definition of PSWP to be 
challenging while 44 percent do not. 
Hospitals concerns over data protections may keep some hospitals from 
disclosing data to their respective PSOs and others from working with a PSO 
at all.  Uncertainty over data protections was a factor for nearly 
three-quarters of hospitals that choose not to work with a PSO.  
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Hospitals concerns over the legal protections create challenges for the 
PSOs that work with them.  In fact, 48 of the 56 PSOs that work with 
hospitals find that hospitals concerns over protections are challenging and 
24 find them very challenging. 
 
Although the  One goal of the Patient Safety Act is to improve patient safety by (in part) 
using the NPSD to gather and aggregate data for national research and 
Common Formats 
learning.  Although the Act permits AHRQ to develop Common Formats, 
enable AHRQ to 
AHRQ faces a challenge universal to developing any standardthat 
aggregate and  a singular approach cannot fit every situation.  Indeed, AHRQ intends for 
the Common Formats to facilitate national-level data aggregation and 
analyze data, 
analysis, rather than to meet the unique needs of every provider and PSO.  
requiring them for 
The Act does not require providers and PSOs to use the Common Formats, 
the NPSD may slow  but AHRQ requires data that PSOs submit to the NPSD to be in the 
its progress   Common Formats. 
Forty-two percent of PSOs surveyed cannot contribute to the NPSD 
because they do not use the Common Formats  
Among the 74 PSOs that responded to our survey, 42 percent (31 of 74) 
neither accept data from members in the Common Formats nor translate 
data into the Common Formats (through a process called mapping).  For 
some PSOs members, using the Common Formats is not an option because 
none exist for the type of events they experience.  In fact, nearly two-thirds 
of PSOs (46 of 74) reported that the lack of Common Formats for the data 
their members collect is a challenge to submitting data for the NPSD.  
The Common Formats  
The Act provided for development of common definitions and 
formats, known as the Common Formats, for reporting patient 
safety event data.  The Common Formats enable AHRQ to 
aggregate and analyze patient safety data that PSOs submit to 
the NPSD.   
Only 12 percent of PSOs (9 of 74) that use the Common Formats use them 
exclusively.  Most PSOs that use them told us that they also accept data in 
other formats, such as those used by their members risk management 
systems.  PSOs accepting data in multiple formats makes it easier for their 
members to submit data.  Forty percent of PSOs that accept data in other 
formats (26 of 65) map the data into the Common Formats or engage 
a third party to do so, but many (47 of 74 PSOs) report that this process is 
challenging.   
In the past few years, AHRQ has made progress in getting PSOs to submit 
data to the NPSD, with the number of records growing from 740,000 in 2017 
to 1.8 million in 2019.  According to AHRQ, 18 PSOs have submitted data to 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  13 
OEI-01-17-00420   
the NSPD, with 3 PSOs submitting the bulk (87 percent) of the records.  
Because PSOs vary in the numbers of and types of providers they serve, 
some are likely to submit more data than others.  In any case, the number 
of records the NPSD has received from a limited number of PSOs shows the 
potential for data aggregation if more PSOs submitted data. 
Challenges with the Common Formats reflect the limits of using 
a standardized approach to capturing patient safety data 
Despite having opportunities to provide input on the design of the 
Common Formats, over half of PSOs (40 of 74) told us that they do not 
capture enough information and nearly as many (31 of 74 PSOs) said they 
capture too much. 
Furthermore, most PSOs (56 of 74) reported that the Common Formats are 
not useful for certain patient safety events.  In some cases, such as 
anesthesia-related events, the Common Formats do not collect the type of 
information that PSOs find useful for learning from these events.  One PSO 
that works with specialty hospitals told us that the Common Formats are 
designed for general acute-care hospitals, and as a result the Common 
Formats do not capture the type of information that a specialty hospital 
might find useful.  For example, a rehabilitation hospital would find it useful 
to know contextual details that are specific to the rehabilitation setting, such 
as a falls having occurred during a routine physical therapy session.  One 
general acute-care hospital told us that these types of limitations with the 
Common Formats led it to use the other category to describe as many as 
half of its events.  A PSO told us that as many as 80 percent of the patient 
safety events it receives fall into the other category.  One consequence of 
this is that the Common Formats recording of an other event does not 
capture enough information, or the right type of information, to make the 
data useful.  Indeed, AHRQ told us that incomplete event data and having 
too many events described as other limits the usefulness of the data for 
analysis and learning.   
The challenges with the Common Formats highlight the difficulty of 
developing a standard for the range of patient safety events that PSOs and 
their members face.  This may explain why PSOs choose not to use the 
Common Formats and why more than half cite as a challenge the lack of 
clarity on how their submitting data for the NPSD would be valuable either 
to them as PSOs (42 of 74 PSOs) or valuable to their members (44 of 74 
PSOs). 
 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  14 
OEI-01-17-00420   
AHRQ provides  Nearly all (43 of 47) PSOs that sought technical assistance from AHRQ over 
the past year found it helpful, and over half of those (27 of 47) said it was 
technical assistance 
very helpful.  Requests for technical assistance related to the PSO program 
that PSOs find 
increased from 350 in 2009 to 1,134 in 2017.  One PSO we interviewed said 
helpful, but its  that AHRQ is quick to respond to requests for technical assistance.  
Similarly, PSOs find AHRQs other avenues of providing technical support 
guidance on the 
helpful.  For example, nearly all PSOs that attended AHRQs annual meeting 
program falls short 
(60 of 64 PSOs) found it to be helpful, as did nearly all of the PSOs that had 
of meeting PSOs 
used AHRQs website resources over the preceding year (66 of 70 PSOs).  
needs   One PSO described the annual meeting as a wonderful opportunity to 
share information with other PSOs and learn from other programs patient 
safety activities.  Several PSOs noted that AHRQs website provides 
valuable information, with one PSO saying that it and its members 
frequently accessed and 
One PSOs Perspective 
utilized AHRQs website 
resources. 
Resources provided through AHRQ 
However, PSOs struggle to  have been supportive and educational 
interpret AHRQs expectations  in the day-to-day work of a PSO. 
for the processes of initial listing 
and continued listing.  Although PSOs that completed the initial listing 
process and PSOs that had recently completed the continued listing process 
generally found AHRQ to be helpful with these processes, some PSOs 
reported challenges in interpreting AHRQs expectations for meeting the 
requirements.39 For example, nearly two-thirds of PSOs (44 of 72) found it 
challenging to interpret AHRQs expectations for initial listing, with 18 of 
these reporting that it was a major challenge.40  PSOs that underwent the 
continued listing process also reported challenges.  Of the PSOs that 
underwent the process in the preceding year, nearly two-thirds (27 of 44) 
found it challenging to interpret AHRQs expectations for the process, and 
23 percent of these (10 of 44) reported that it was a major challenge.  Some 
PSOs provided examples of challenges such as difficulty in determining 
exactly what they needed to prepare for the continued listing process, and 
AHRQs being inconsistent in its expectations.  
Although AHRQ provides technical assistance to PSOs, HHS delegated the 
responsibility for interpretation and enforcement of the legal protections to 
OCR.  Therefore, AHRQ does not provide legal guidance to PSOs on the 
definition of PSWP.  Accordingly, AHRQ told us that it refers PSOs with 
complex questions about legal protections to OCR or brokers a call between 
the PSO and OCR.  The fact that hospitals and PSOs both cited the issue of 
the protections as a challenge suggests that additional support from AHRQ 
and OCR might be beneficial.   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  15 
OEI-01-17-00420   
CONCLUSION AND RECOMMENDATIONS 
Congress intended for the PSO program to be unique and powerful among 
patient safety programs.  It is the first and only nationwide program that 
offers legal protections for providers to disclose patient safety events and 
learn from them.  Where providers were once reluctant to discuss patient 
safety events for fear of litigation, they may now seek expert analysis from 
PSOs and discuss these events with peers that are fellow PSO members.  
Furthermore, through the NPSD, the PSO program is the only 
comprehensive program that aims to enable learning on a national scale 
about the causes of patient safety events. 
The PSO program has the potential to improve health care.  Indeed, this 
review shows that the program has made progress in its first decade.  AHRQ 
has invested in developing and revising the Common Formats, and in 
creating the NPSD.  Over half of hospitals work with a PSO; those hospitals 
find their participation valuable, with many reporting measurable 
improvement in patient safety.  The number of records in the NPSD is 
growing, and AHRQ has launched a public-facing website for sharing NPSD 
data. 
However, despite this progress, the PSO program faces challenges.  A lack 
of hospital familiarity with the program hinders PSOs ability to recruit more 
hospitals, and concerns over the programs legal protections may keep 
hospitals from fully engaging with PSOs.  Furthermore, PSOs have not 
universally adopted the Common Formats.  Ultimately, these challenges 
have slowed AHRQs progress toward creating a robust NPSD.  As a result, 
the PSO program has yet to realize its promise of enabling learning and 
advances in patient safety on a national scale.  For the PSO program to fully 
realize its potential, AHRQ should do more to support and promote the 
program. 
Therefore, we recommend that AHRQ: 
Develop and execute a communications strategy to increase 
hospitals awareness of the program and its value to 
participants   
Lack of familiarity with and misperceptions of PSOs among hospitals are 
challenges that PSOs still face, 10 years after the program began.   
Therefore, AHRQ should do more to promote the program by developing 
and executing a communications strategy.  In doing so, AHRQ could work 
to engage provider associations, professional societies, risk management 
organizations, and other stakeholder organizations.  As part of this 
outreach, AHRQ should explain how aspects like the legal protections and 
shared learning make working with a PSO different from other quality- and 
safety-related initiatives.  Regarding the legal protections for PSWP, AHRQ 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  16 
OEI-01-17-00420   
could reach out to OCR to discuss how the two can improve stakeholders 
understanding of the legal protections.  Such discussion could include 
assessing the potential for formalizing a pathway for PSOs and their 
members to contact OCR for timely, case-by-case guidance on the legal 
protections.  
AHRQ could take advantage of the launch of the public-facing NPSD 
website and use it to promote the PSO program more broadly.   
Take steps to encourage PSOs to participate in the NPSD, 
including accepting data into the NPSD in other formats in 
addition to the Common Formats  
Nearly 10 years after OIG encouraged AHRQ to invest in the Common 
Formats, a number of PSOs (31 of 74) still do not use them.  However, the 
NPSD accepts only data that is in the Common Formats, limiting its ability to 
aggregate data on a scale that would fulfill the promise of national learning.   
For this reason, in addition to accepting data in the Common Formats, 
AHRQ should consider accepting data to the NPSD in other formats as well.  
In doing so, AHRQ could prioritize accepting data in existing reporting 
formats such as those used by State and other reporting systems.  This 
might yield large gains in data for the NPSD while reducing redundancies in 
the reporting workload for providers.  Furthermore, AHRQ should also 
explore advanced technologies that may enable the NPSD to accept and 
analyze unstructured data in the future. 
Beyond accepting data in additional formats, AHRQ should take further 
steps to encourage providers and PSOs to submit data to the NPSD. 
Such steps might include: 
1.  Developing a campaign to encourage providers and PSOs to 
address a specific, high-priority type of patient safety event.  Central 
to the campaign would be submitting a critical mass of data about 
the event to the NPSD for analysis.  AHRQ could use the resulting 
learning to provide feedback on preventing the event as an example 
of the NPSDs value. 
2.  Collecting and analyzing data on reasons why PSOs do not submit 
data to the NPSD.  AHRQ could use that information to develop 
next steps for addressing challenges that PSOs face beyond what we 
identified within this report. 
Such steps could increase the likelihood that PSOs will contribute data to 
the NPSD and offer a quicker path to fulfilling the promise of national 
learning envisioned within the Act. 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  17 
OEI-01-17-00420   
Update guidance for PSOs on the initial and continued listing 
processes  
AHRQ released a self-assessment toolits only comprehensive guide on 
eligibility, listing, operational, and other requirements for PSOsin 
September 2009, less than a year after publishing the final rule 
implementing the Patient Safety Act.  Since issuing the self-assessment tool, 
AHRQ has had nearly 10 years of experience in working with PSOs with 
varying business models and approaches to meeting the requirements of 
the Patient Safety Act and the final rule.   
 
To provide better guidance for PSOs on the initial and continued listing 
processes, AHRQ should first consider whether a self-assessment tool is the 
best format for guiding PSOs through these processes and whether this tool 
is adequate guidance on its own.  AHRQ should then update the tool 
and/or produce additional guidance as appropriate. 
 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  18 
OEI-01-17-00420   
AGENCY COMMENTS AND OIG RESPONSE 
AHRQ concurred with our first and third recommendations, and partially 
concurred with our second recommendation. 
Regarding our first recommendation, AHRQ said that it will develop and 
execute a communications strategy to increase hospitals awareness of the 
PSO program and its value.  The strategy will include a review of AHRQs 
website and resources, andsubject to available resourcesoutreach to 
organizations of providers and other stakeholders.  Also as part of its 
strategy, AHRQ will discuss with OCR how to improve stakeholder 
understanding of the PSO programs legal protections.   
Regarding our second recommendation, AHRQ concurred with taking steps 
to encourage PSOs to participate in the NPSD, but it did not concur with 
accepting data to the NPSD in other formats.  AHRQ stated that, subject to 
available resources, it will consider developing a campaign to focus on 
collecting data on a specific event type to encourage NPSD participation, 
and that it will discuss that possibility with PSOs at its 2020 PSO Annual 
Meeting.  AHRQ will also explore the use of advanced technologies that 
might make it possible for the NPSD to accept unstructured data.  AHRQ 
identified challenges to accepting data into the NPSD in existing formats in 
addition to the Common Formats but stated it could consider doing so 
should technological and other factors make it feasible. 
Finally, regarding our third recommendation, AHRQ stated that it will revise 
its PSO self-assessment tool to more clearly link the contents to additional 
resources and tools it has developed based on experience with the PSO 
listing process. 
For the full text of AHRQs comments, see Appendix B. 
 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  19 
OEI-01-17-00420   
APPENDIX A: Statistics for Responses to 
Select Items From Surveys 
Survey of Hospitals  
Sample  Point  95% confidence 
Description  
size  estimate  interval 
PSO participation 
Percentage of hospitals that work with a PSO  474  59.5%  55.363.5% 
Percentage of hospitals that do not work with  474  40.5%  36.544.7% 
a PSO 
Number of years the hospital has worked with a PSO 
Percentage of hospitals that have worked with 
282  8.5%  5.912.1% 
a PSO for less than 1 year 
Percentage of hospitals that have worked with 
282  59.2%  53.864.4% 
a PSO for 1 to 5 years 
Percentage of hospitals that have worked with 
282  32.3%  27.437.5% 
a PSO for 6 years or more 
Importance of opportunity to improve patient safety in deciding to work with a PSO 
Percentage of hospitals that found opportunity 
282  94.0%  90.896.1% 
to improve patient safety very important 
Percentage of hospitals that found opportunity 
282  5.0%  3.17.9% 
to improve patient safety somewhat important 
Percentage of hospitals that found opportunity 
282  1.1%  0.43.0% 
to improve patient safety slightly important 
Percentage of hospitals that found opportunity 
282  0%  0.12.2% 
to improve patient safety not important 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  20 
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Sample  Point  95% confidence 
Description  
size  estimate  interval 
Importance of opportunity to learn from analysis of aggregate data from providers in 
deciding to work with a PSO 
Percentage of hospitals that found opportunity to 
282  86.5%  82.489.8% 
learn from analysis very important 
Percentage of hospitals that found opportunity to 
282  7.7%  7.714.5% 
learn from analysis somewhat important 
Percentage of hospitals that found opportunity to 
282  2.8%  1.55.3% 
learn from analysis slightly important 
Percentage of hospitals that found opportunity to 
282  0%  0.12.2% 
learn from analysis not important 
Importance of privilege and confidentiality protections for PSWP in deciding to work with a 
PSO 
Percentage of hospitals that found PSWP privilege 
282  82.6%  78.186.4% 
and confidentiality protections very important 
Percentage of hospitals that found PSWP privilege 
282  14.9%  11.419.2% 
and confidentiality protections somewhat important 
Percentage of hospitals that found PSWP privilege 
282  1.8%  0.84.0% 
and confidentiality protections slightly important 
Percentage of hospitals that found PSWP privilege 
282  0.7%  0.22.5% 
and confidentiality protections not important 
Value of Working with a PSO 
Percentage of hospitals that found working with a 
282  51.8%  46.357.2% 
PSO very valuable 
Percentage of hospitals that found working with a 
282  37.6%  32.543.0% 
PSO somewhat valuable 
Percentage of hospitals that found working with a 
282  7.8%  5.311.3% 
PSO slightly valuable 
Percentage of hospitals that found working with a 
282  2.8%  1.55.3% 
PSO not valuable 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  21 
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Sample  Point  95% confidence 
Description 
size  estimate  interval 
Usefulness of PSO analysis in preventing future patient safety events  
Percentage of hospitals that found working with 
a PSO useful to preventing future patient safety  282  80.1%  75.584.1% 
events 
Percentage of hospitals that found working with 
282  19.9%  15.924.6% 
a PSO not useful to preventing future patient 
safety events 
Usefulness of PSO analysis in understanding the causes of patient safety events  
Percentage of hospitals that found analysis from 
a PSO useful to understanding the cause of  282  71.6%  66.576.3% 
patient safety events 
Percentage of hospitals that found analysis from 
282  28.4%  23.733.5% 
a PSO not useful to understanding the cause of 
patient safety events 
Measurable improvement in patient safety from PSO analysis 
Percentage of hospitals that found PSO analysis 
resulted in measurable improvement in patient  282  62.8%  57.467.9% 
safety 
Percentage of hospitals that found PSO analysis 
282  37.2%  32.242.6% 
did not result in measurable improvement in 
patient safety 
Helpfulness of PSO analysis of PSWP from its members [i.e., benchmarking] to hospitals 
   
Percentage of hospitals that found PSO analysis 
249  96.0%  93.097.7% 
of PSWP helpful 
Percentage of hospitals that found PSO analysis  249  4.0%  2.37.0% 
of PSWP not helpful 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  22 
OEI-01-17-00420   
Sample  Point  95% confidence 
Description 
size  estimate  interval 
Helpfulness of PSO service of cultivating a culture of safety to hospitals 
   
Percentage of hospitals that found PSO service of 
265  95.1%  92.097.0% 
cultivating a culture of safety helpful 
Percentage of hospitals that found PSO service of  265  4.9%  3.08.0% 
cultivating a culture of safety not helpful 
Helpfulness of PSO service of safe tables/member convenings to hospitals 
Percentage of hospitals that found PSO service of 
207  94.7%  91.096.9% 
safe tables/member convenings helpful 
Percentage of hospitals that found PSO service of  207  5.3%  3.19.0% 
safe tables/member convenings not helpful 
Lack of familiarity with the PSO program as a reason for not working with a PSO 
Percentage of hospitals that found lack of 
familiarity with the PSO program an important  192  60.9%  54.467.1% 
reason  
Percentage of hospitals that found lack of 
192  39.1%  32.945.6% 
familiarity with the PSO program not an important 
reason  
At least one form of redundancy as a reason for not working with a PSO 
Percentage of hospitals that found at least one 
192  69.8%  63.475.5% 
form of redundancy a very important reason  
Percentage of hospitals that found at least one 
192  20.3%  15.526.1% 
form of redundancy a somewhat important reason 
Percentage of hospitals that found at least one 
192  7.3%  4.511.5% 
form of redundancy a slightly important reason 
Percentage of hospitals that found at least one 
192  2.6%  1.25.8% 
form of redundancy not an important reason 
Already working with another entity to improve patient safety (including nonlisted PSOs) as a 
reason for not working with a PSO 
Percentage of hospitals that found working with 
another entity to improve patient safety an  192  79.2%  73.384.0% 
important reason 
Percentage of hospitals that found working with 
192  20.8%  16.026.7% 
another entity to improve patient safety not an 
important reason 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  23 
OEI-01-17-00420   
 
Sample  Point  95% confidence 
Description  
size  estimate  interval 
Redundancy to internal efforts as a reason for not working with a PSO  
Percentage of hospitals that found redundancy 
192  81.8%  76.186.3% 
to internal efforts an important reason 
Percentage of hospitals that found redundancy  192  18.2%  13.723.9% 
to internal efforts not an important reason 
Redundancy to Federal reporting as a reason for not working with a PSO 
Percentage of hospitals that found redundancy 
192  83.3%  77.887.7% 
to Federal reporting an important reason 
Percentage of hospitals that found redundancy  192  16.7%  12.322.2% 
to Federal reporting not an important reason 
Redundancy to State reporting as a reason for not working with a PSO 
Percentage of hospitals that found redundancy 
192  79.7%  73.984.5% 
to State reporting an important reason 
Percentage of hospitals that found redundancy  192  20.3%  15.526.1% 
to State reporting not an important reason 
Workload as a reason for not working with a PSO 
Percentage of hospitals that found workload is 
192  87.0%  81.990.8% 
an important reason 
Percentage of hospitals that found workload is  192  13.0%  9.218.1% 
not an important reason 
Lack of value as a reason for not working with a PSO  
Percentage of hospitals that found lack of value 
192  67.2%  60.773.1% 
is an important reason 
Percentage of hospitals that found lack of value  192  32.8%  27.039.3% 
is not an important reason 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  24 
OEI-01-17-00420   
 
Sample  Point  95% confidence 
Description  
size  estimate  interval 
Uncertainty over privilege and confidentiality protections as a challenge to working with a 
PSO 
Percentage of hospitals that found uncertainty over 
privilege/confidentiality protections to be a major  282  23.8%  19.528.7% 
challenge 
Percentage of hospitals that found uncertainty over 
privilege/confidentiality protections to be a minor  282  27.0%  22.432.0% 
challenge 
Percentage of hospitals that found uncertainty over 
privilege/confidentiality protections not to be a  282  49.3%  43.954.7% 
challenge 
Determining what constitutes PSWP as a challenge to working with a PSO 
Percentage of hospitals that found determining 
282  57.1%  51.762.4% 
what constitutes PSWP a to be a challenge 
Percentage of hospitals that found determining  282  42.9%  37.648.4% 
what constitutes PSWP not to be a challenge 
Interpreting the 2016 HHS guidance document as a challenge to working with a PSO 
Percentage of hospitals that found interpreting the 
282  56.0%  50.661.3% 
2016 HHS guidance document to be a challenge 
Percentage of hospitals that found interpreting the  282  44.0%  38.749.4% 
2016 HHS guidance document not to be a challenge 
Uncertainty of privilege and confidentiality protections as a reason for not working with a 
PSO 
Percentage of hospitals that found uncertainty of 
privilege and confidentiality protections an  192  74.5%  68.379.8% 
important reason 
Percentage of hospitals that found uncertainty of 
192  25.5%  20.231.7% 
privilege and confidentiality protections not an 
important reason 
   
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Survey of PSOs 
 
Description   Percentage  Number/Total 
PSO nonprofit status 
Percentage of PSOs that are nonprofit  62.2%  46/74 
37.8%  28/74 
Percentage of PSOs that are not nonprofit  
Health care provider status of PSO or its parent company 
Percentage of PSOs or parent companies that are health 
33.8%  25/74 
care providers 
Percentage of PSOs or parent companies that are not health  66.2%  49/74 
care providers 
 
Offering aggregate analysis of PSWP across providers 
 
Percentage of PSOs that offer aggregate analysis of PSWP 
94.6%  70/74 
across providers 
Percentage of PSOs that do not offer aggregate analysis of  5.4%  4/74 
PSWP across providers 
 
Helping cultivate a culture of safety 
 
Percentage of PSOs that cultivate a culture of safety  91.9%  68/74 
8.1%  6/74 
Percentage of PSOs that do not cultivate a culture of safety 
 
Offering at least one learning-based service 
 
Percentage of PSOs that offer at least one learning-based 
89.2%  66/74 
service 
Percentage of PSOs that do not offer at least one learning- 10.8%  8/74 
based service 
Offering safe tables or safety huddles 
Percentage of PSOs that offer either safe tables, safety 
73.0%  54/74 
huddles, or both  
Percentage of PSOs that offer neither safe tables nor  27.0%  20/74 
safety huddles 
   
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Description     Percentage  Number/Total 
 
Working with at least one general acute-care hospital 
 
Percentage of PSOs that work with at least one general 
75.7%  56/74 
acute-care hospital 
Percentage of PSOs that do not work with at least one  24.3%  18/74 
general acute-care hospital 
Number of general acute-care hospitals with which PSO works 
0   24.3%  18/74 
1 to 9   17.6%  13/74 
10 to 49   28.4%  21/74 
50 to 99  14.9%  11/74 
100 or more   14.9%  11/74 
 
Working with more than one provider type 
 
Percentage of PSOs that work with more than one provider 
82.4%  61/74 
type 
Percentage of PSOs that do not work with more than one  17.6%  13/74 
provider type 
Hospital concerns about data protections as a challenge to PSOs 
 
Percentage of PSOs that find hospital concerns about data  85.7%  48/56 
protections to be a challenge 
Percentage of PSOs that find hospital concerns about data  14.3%  8/56 
protections not to be a challenge 
Hospitals not submitting data as a challenge to PSOs  
Percentage of PSOs that find hospitals not 
62.5%  35/56 
submitting data to be a challenge 
Percentage of PSOs that find hospitals not  37.5%  21/56 
submitting data not to be a challenge 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  27 
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Description     Percentage  Number/Total 
Accepting data from members in Common Formats and/or translating data into Common 
Formats through mapping 
Percentage of PSOs that neither accept CF nor map  41.9%  31/74 
Percentage of PSOs that do not accept CF but map  9.5%  7/74 
Percentage of PSOs that accept CF but do not map  23.0%  17/74 
Percentage of PSOs that accept CF and map  25.7%  19/74 
A lack of Common Formats relevant to the data that PSOs members collect as a challenge to 
PSOs  
Percentage of PSOs that found a lack of Common Formats 
relevant to the data that PSOs members collect to be a  62.2%  46/74 
challenge 
Percentage of PSOs that found a lack of Common Formats 
37.8%  28/74 
relevant to the data that PSOs members collect not to be a 
challenge 
Format of patient safety reports accepted by PSOs 
Percentage of PSOs that accept patient safety reports in 
12.2%  9/74 
AHRQ's Common Formats 
Percentage of PSOs that accept patient safety reports in a 
51.4%  38/74 
format other than the CF 
Percentage of PSOs that accept patient safety reports in both   36.5%  27/74 
Mapping data to the Common Formats 
Percentage of PSOs that map data to the Common 
40.0%  26/74 
Formats 
Percentage of PSOs that do not map data to the  60.0%  39/74 
Common Formats 
Mapping data onto the Common Formats as a challenge to PSOs 
Percentage of PSOs that found mapping data onto 
63.5%  47/74 
the Common Formats to be a challenge 
Percentage of PSOs that found mapping data onto  36.5%  27/74 
the Common Formats not to be a challenge 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  28 
OEI-01-17-00420   
 
Description     Percentage  Number/Total 
Common Formats not capturing enough information as a challenge to PSOs 
Percentage of PSOs that found that the Common Formats do 
54.1%  40/74 
not capture enough information to be a challenge 
Percentage of PSOs that found that the Common Formats do  46.0%  34/74 
not capture enough information not to be a challenge 
Common Formats capturing too much information as a challenge to PSOs 
Percentage of PSOs that found that the Common Formats 
41.9%  31/74 
capture too much information to be a challenge  
Percentage of PSOs that found that the Common Formats  58.1%  43/74 
capture too much information not to be a challenge 
Usefulness of the Common Formats for certain types of patient safety events as a challenge 
to PSOs 
 
Percentage of PSOs that found usefulness of the Common 
75.7%  56/74 
Formats for certain types of patient safety events to be a 
challenge 
Percentage of PSOs that found usefulness of the Common 
24.3%  18/74 
Formats for certain types of patient safety events not to be a 
challenge 
Lack of clarity on how submitting to the NPSD would provide value to this PSO as a 
challenge 
Percentage of PSOs that found a lack of clarity on how 
submitting to the NPSD would provide value to this PSO to  56.8%  42/74 
be a challenge 
Percentage of PSOs that found a lack of clarity on how 
43.2%  32/74 
submitting to the NPSD would provide value to this PSO not 
to be a challenge 
 
   
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OEI-01-17-00420   
 
Description     Percentage  Number/Total 
Lack of clarity on how submitting to the NPSD would provide value to PSOs members as a 
challenge 
Percentage of PSOs that found a lack of clarity on how 
submitting to the NPSD would provide value to PSOs  59.5%  44/74 
members to be a challenge 
Percentage of PSOs that found a lack of clarity on how 
40.5%  30/74 
submitting to the NPSD would provide value to PSOs 
members not to be a challenge 
Helpfulness of AHRQ with technical assistance over the past year 
Percentage of PSOs that found AHRQ to be very helpful with 
57.5%  27/47 
technical assistance 
Percentage of PSOs that found AHRQ to be somewhat 
21.3%  10/47 
helpful with technical assistance 
Percentage of PSOs that found AHRQ to be slightly helpful 
12.8%  6/47 
with technical assistance 
Percentage of PSOs that found AHRQ to not be helpful with 
8.5%  4/47 
technical assistance 
Helpfulness of AHRQ with their annual meeting over the past year  
Percentage of PSOs that found AHRQs annual meeting to be 
93.8%  60/64 
helpful 
Percentage of PSOs that found AHRQs annual meeting to  6.3%  4/64 
not be helpful 
Helpfulness of AHRQ with website resources over the past year  
Percentage of PSOs that found AHRQ to be helpful with 
94.3%  66/70 
website resources 
Percentage of PSOs that found AHRQ to not be helpful with  5.7%  4/70 
website resources 
   
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  30 
OEI-01-17-00420   
Description     Percentage  Number/Total 
Helpfulness of AHRQ with technical assistance over the past year 
Percentage of PSOs that found AHRQ to be very helpful 
57.5%  27/47 
with technical assistance 
Percentage of PSOs that found AHRQ to be somewhat 
21.3%  10/47 
helpful with technical assistance 
Percentage of PSOs that found AHRQ to be slightly helpful 
12.8%  6/47 
with technical assistance 
Percentage of PSOs that found AHRQ to not be helpful 
8.5%  4/47 
with technical assistance 
Helpfulness of AHRQ with their annual meeting over the past year  
Percentage of PSOs that found AHRQs annual meeting to 
93.8%  60/64 
be helpful 
Percentage of PSOs that found AHRQs annual meeting to  6.3%  4/64 
not be helpful 
Helpfulness of AHRQ with website resources over the past year  
Percentage of PSOs that found AHRQ to be helpful with 
94.3%  66/70 
website resources 
Percentage of PSOs that found AHRQ to not be helpful  5.7%  4/70 
with website resources 
Interpreting AHRQ's expectations for initial listing as a challenge to PSOs 
Percentage of PSOs that found interpreting AHRQs 
25.0%  18/72 
expectations for initial listing to be a major challenge 
Percentage of PSOs that found interpreting AHRQs 
36.1%  26/72 
expectations for initial listing to be a minor challenge 
Percentage of PSOs that found interpreting AHRQs 
38.9%  28/72 
expectations for initial listing not to be a challenge 
Interpreting AHRQ's expectations for continued listing in the past year as a challenge to 
PSOs 
Percentage of PSOs that found interpreting AHRQs 
22.7%  10/44 
expectations for continued listing to be a major challenge 
Percentage of PSOs that found interpreting AHRQs 
38.6%  17/44 
expectations for continued listing to be a minor challenge 
Percentage of PSOs that found interpreting AHRQs 
38.6%  17/44 
expectations for continued listing not to be a challenge 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  31 
OEI-01-17-00420   
APPENDIX B: Agency Comments 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  32 
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Patient Safety Organizations:  Hospital Participation, Value, and Challenges  33 
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Patient Safety Organizations:  Hospital Participation, Value, and Challenges  34 
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Patient Safety Organizations:  Hospital Participation, Value, and Challenges  35 
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Patient Safety Organizations:  Hospital Participation, Value, and Challenges  36 
OEI-01-17-00420   
ACKNOWLEDGMENTS 
Elizabeth Sandefer served as the team leader for this study.  Others in the 
Office of Evaluation and Inspections who conducted the study include 
Malaena Taylor and Shanna Weitz.  Office of Evaluation and Inspections 
staff who provided support include Althea Hosein, Christine Moritz, and 
Mike Novello. 
This report was prepared under the direction of Joyce Greenleaf, Regional 
Inspector General for Evaluation and Inspections in the Boston regional 
office, and Kenneth Price, Deputy Regional Inspector General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  37 
OEI-01-17-00420   
 
ENDNOTES 
1 James, J.T. 2013. A New, Evidence-Based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety, 
Vol. 9(3): 122-128. 
2 73 Fed. Reg. 70732 (Nov. 21, 2008). 
3 Ibid. 
4 42 U.S.C.  299b-22. 
5 42 U.S.C.  299b-23.  
6 Institute of Medicine, To Err Is Human: Building A Safer Health System, November 1999.  Accessed at 
http://nationalacademies.org/hmd/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx on September 15, 2017.  
7 About 13.5 percent of hospitalized beneficiaries experienced adverse events resulting in serious harm, and an additional 
13.5 percent experienced events that resulted in temporary harm.  See OIG, Adverse Events in Hospitals: A National Incidence 
Among Medicare Beneficiaries, November 2010.  Accessed at https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf on 
September 18, 2017. 
8 71 Fed. Reg. 28701 (May 17, 2006). 
9 73 Fed. Reg. 70732 (Nov. 21, 2008). 
10 AHRQ, Frequently Asked Questions, Patient Safety Organization (PSO) Program.  Accessed at 
https://www.pso.ahrq.gov/faq#BenefitstoHealthcareProviders on September 4, 2019. 
11 Ibid.  
12 The Office for Civil Rights is responsible for overseeing the confidentiality protections for PSWP. 
13 42 U.S.C.  299b-21(7)(A)(i). 
14 42 CFR  3.204(a)(1). 
15 42 CFR  3.204(a)(2). 
16 42 CFR  3.204(a)(3). 
17 81 Fed. Reg. 32655 (May 24, 2016).  
18 42 U.S.C.  299b-23(a). 
19 42 U.S.C.  299b-23(c). 
20 The Act directs the Secretary to include information resulting from analyses of the NPSD in HHSs annual quality reports. 
21 Government Accountability Office, Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot 
Yet Be Evaluated. January 2010.  Available online at http://www.gao.gov/new.items/d10281.pdf. 
22 42 CFR 3.102(b)(2)(iii). 
23 P.L. No. 109-41  2, PHSA,  924, 42 U.S.C.  299b-24. 
24 42 CFR 3.104. 
25 P.L. No. 109-41  2, PHSA,  924, 42 U.S.C. 299b24(a)(2). 
26 PSOs listed prior to the effective date of the final rule implementing the Patient Safety Act (January 19, 2009) had to apply for 
a new initial listing after the effective date of the final rule. 
27 42 CFR 3.108(e). 
28 P.L. No. 109-41  2, PHSA,  926, 42 U.S.C. 299b-25. 
29 42 CFR 3.304(b). 
30 The Department of Financial and Professional Regulation v. Walgreen Co, 970 N.E.2d 552 (Ill. 2012). 
31 Tibbs v. Bunnell, 448 S.W.3d 796 (Ky. 2014). 
32 Charles v. Southern Baptist Hosp. of Florida, Inc., 209 So. 3d 1199 (Fla. Jan. 31, 2017). 
33 Tibbs v. Bunnell, 136 S. Ct. 2504 (June 27, 2016). 
34 S. Baptist Hosp. of Fla., Inc. v. Charles, 138 S. Ct. 129 (Oct. 2, 2017).  
35 Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Ky. Sept. 22, 2016). 
36 81 Fed. Reg. 32656 (May 24, 2016).  
37 OIG, Hospital Incidence Reports Do Not Capture Most Patient Harm (OEI-06-09-00091), January 2012.  Accessed at 
https://oig.hhs.gov/oei/reports/oei-06-09-00091.pdf on July 24, 2019. 
38 AHRQ, Patient Safety Primer. January 2019. Available online at https://psnet.ahrq.gov/primers/primer/5/Culture-of-Safety.  
39 We define recently as those PSOs that completed continued listing within the year prior to receiving our survey in May 2018. 
40 All but 2 of the 74 PSOs that responded to our survey recalled their experiences with initial listing.  The remaining two 
respondents were unable to answer this question. 
Patient Safety Organizations:  Hospital Participation, Value, and Challenges  38 
OEI-01-17-00420   
ABOUT THE OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public 
Law 95-452, as amended, is to protect the integrity of the Department of 
Health and Human Services (HHS) programs, as well as the health and 
welfare of beneficiaries served by those programs.  This statutory mission is 
carried out through a nationwide network of audits, investigations, and 
inspections conducted by the following operating components: 
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by conducting audits with its own audit resources or by overseeing audit 
Services 
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responsibilities and are intended to provide independent assessments of 
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abuse, and mismanagement and promote economy and efficiency 
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to provide HHS, Congress, and the public with timely, useful, and reliable 
and Inspections 
information on significant issues.  These evaluations focus on preventing 
fraud, waste, or abuse and promoting economy, efficiency, and 
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also present practical recommendations for improving program operations.   
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investigations of fraud and misconduct related to HHS programs, 
Investigations 
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legal services to OIG, rendering advice and opinions on HHS programs and 
the Inspector 
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General 
OCIG represents OIG in all civil and administrative fraud and abuse cases 
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the anti-kickback statute and other OIG enforcement authorities.