Attachment I -- Public Comments

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Copy of the Prototype Consumer Reporting System for Patient Safety Events
Tuesday, November 13, 2012 9:23:23 AM
Consumer Reporting System for Patient Safety - Comments.docx
News Release_SOS Release 053110.pdf
Online+SOS_One+Page+Description+with+Logo+100212.docx
Online+SOS_One+Page+Description_River+Oaks+Hosp.docx
Complaint or Grievance Process HRMC.pptx
PEP narrative.docx

From: [email protected] [mailto:[email protected]] On Behalf Of Douglas Dotan
Sent: Friday, November 09, 2012 4:51 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Elizabeth A. Smith, PhD; Matthew C. Mireles, MPH, PhD; Anngail Smith; AHRQ Smith, Elizabeth; Erel
Joffe, MD
Subject: Re: Copy of the Prototype Consumer Reporting System for Patient Safety Events

Hi Doris,
Attached please find severl documents in response to Dr. Clancy's request for Comment. We
do NOT recommend that this project be funded as proposed. On the other hand we DO
recommend that such a program be made available in a totally different, more effective and
much less costly format - in fact such a program already exists ustilizing modern technology
and lean thinking.
If you are interested in the technology we can send you the video of the technolgy and
methodolgy we recommend that AHRQ supports. It leverages social media for medicine.
Best wishes,
Douglas
On Wed, Oct 31, 2012 at 8:41 AM, Lefkowitz, Doris C. (AHRQ)
wrote:

From: [email protected] [mailto:[email protected]] On Behalf Of Douglas Dotan
Sent: Sunday, October 28, 2012 4:47 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Elizabeth A. Smith, PhD; Matthew C. Mireles, MPH, PhD; Anngail Smith; AHRQ Smith, Elizabeth; Erel
Joffe, MD
Subject: Copy of the Prototype Consumer Reporting System for Patient Safety Events
Dear Doris,
Please send us a copy of the proposed collection plans, data collection instruments, and specific details
on the estimated burden.
The PSO Services Group and its partners would like to review and comment on ther proposed system.
We have had a similar system in place for several years. It has been refined and expanded and is now
called the 3-D PEP or 3 Dimesional Patient Experience Program integrating patient experience input

and caregiver recorded with an event form. We believe that our existing program already meets the
proposed project requirements. We would like to verify that we are correct by reviewing the proposal
before submitting our comments.
We apreciate your prompt response.
Best wishes,
Douglas
Best wishes,
Douglas

-Douglas B. Dotan, MA, CQIA (ASQ)
President and CEO
CRG Medical, Inc.
2630 Fountain View Drive
Suite 408
Houston, Texas 77057
(713) 825-7900
"Communicating from the Bedside to the Boardroom"
www.crgmedical.com
"CONFIDENTIALITY NOTICE: This communication, including any attachments, may
contain confidential information and is intended only for the individual or entity to whom it
is addressed. Any review, dissemination, or copying of this communication by anyone other
than the intended recipient is strictly prohibited. If you are not the intended recipient, please
notify us immediately by reply email to [email protected] and delete or destroy all
copies of the original message and any attachments thereto. Email sent to or from the CRG
Medical, Inc. may be retained as required by law or regulation."

Consumer Reporting System for Patient Safety
August 30, 2012 Request for Comments by Dr. Carolyn Clancy
Response by Douglas B. Dotan, MA, CQIA, Executive Director, PSO Services Group, LLC
November9,2012

Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's information
collection are requested with regard to any of the following:
(a) Whether the proposed collection of information is necessary for the proper
performance of AHRQ health care research and health care information
dissemination functions, including whether the information will have practical utility;
We at the PSO Services Group, LLC, an AHRQ listed Patient Safety Organization
have two partnering companies, a not for profit 501 ( C ) (3) The Community Medical
Foundation for Patient Safety and CRG Medical, Inc. a Healthcare IT company both
based in Houston, Texas feel that the proposed collection of information, if collected
and used in the appropriate manner will have practical utility. We do not feel that it is
the proper performance of AHRQ health care research and health care information
dissemination. Our research and experience, even though not heavily funded, shows
that patient information will be best collected and acted upon at the local level by each
individual hospital and/or hospital system.
It is not accurate to state that a system to conduct the function of ‘patient reporting’ does
not exist. In the year 2006, the Community Medical Foundation for Patient Safety
worked with the Texas A&M Rural and Community Healthcare Institute - RCHI on
PatientSpeak, a precursor to the SOS Share-Our-Stories program. SOS was in
development since 2006 and copyrighted in 2006. Around 2009, the Foundation came
close to installing SOS at Twelve Oaks (River Oaks) Hospital (two sites) for patients and
staff to report stories. The hospital shut down within days of launching the system. The
leaders of the Foundation were asked to serve as an independent member of the
hospital's patient safety committee. They wanted to include information and forms at
admission. At the same time, CRG Medical, Inc. offered an electronic version of KBCore
SOS. It was officially announced June 1, 2010. See attached press Release.
Because the organizations knew that the purpose of collecting patient stories was to
improve patient care, it was imperative to have a single system where patient stories,
complaints/grievances and event reports all went to a centralized patient experience
review entity to coordinate patient centered care. The entire burden of the collection and
analysis of this data should be the responsibility of the providers of care NOT the
Agency for Healthcare Research and Quality. The lessons learned should be shared
with the existing Patient Safety Organizations in a Common Format and shared with
AHRQ and the NPSD via the PSO PPC. These organizations already exist and creating
another government program that is founded on ‘failure’ to perform and punitive in

nature rather than on preventive, non-punitive action is what is needed. Funding should
be given to organizations that can do a better job, in real-time and at a much lower cost.
This proposed program is a waste of time and funds, particularly when it can be
executed by people already on the ground more effectively and will be sustained over
time.
(b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the
proposed collection(s) of information;
We know from experience that the proposed costs are approximately 50% higher that
can be performed by the PSO Services Group and its strategic partners. CRG
Medical, the developer of the SOS, Automated PSO Common Formats, and a
HCAHPS provider provides services for surveying by phone 900 patients for 300
completes a year for $6,000.
(c) ways to enhance the quality, utility, and clarity of the information to be collected;
The attached briefing sheets for patients demonstrate how the SOS process is
conducted. The patients at pre-admission to the hospital are given a sign in code to
the hospital’s intranet. They are briefed that the PEP – Patient Experience Program
exists. They are told how to use SOS to communicate with the quality staff over the
computer, cell phone during their stay or after their release. They are told to tell their
stories about their experience with staff – good or not so good as it may be. The
quality staff can then respond in real-time, just as in the TPS system and address
patient needs and continually improve the delivery of care. Staff can review daily if
patient stories correlate with reports by staff. This matching of events/complaints/and
patient experience will contribute daily to coordinated care and better, less costly
outcomes. Ultimately we will have much higher HCAHPS score too.
(d) ways to minimize the burden of the collection of information upon the respondents,
including the use of automated collection techniques or other forms of information
technology.
The PSO Services Group has worked with two of its technology partners, CRG
Medical Inc. and the iHealthExchange that provides a safe communication platform
for the Health Information Exchange – HIE (iHealth Trust) to develop the KBCore
Mobile CF (Common Formats) for use in a mobile device or on a desktop to
communicate information rapidly and accurately. This same technology can be used
by patients to share their stories. The PEP (Patient Experience Program) is
accessible today at the Hunt Memorial District in Greenville, Texas for their patients.
This can be the beta site for all hospitals in the country – it has already been funded –
why waste public money on a system that has not been tried and because it is about
failures, will probably fail itself?
These comments are being submitted in response to this notice. We trust they will be
summarized and included in the Agency's subsequent request for OMB approval of the
proposed information collection. We recommend that the request NOT be submitted as

proposed. The approach does not solve the problem. Following are comments on
inaccuracies/omissions in the document that reviewers may consider.


I.IntroductoryPagesforWebsite
p.1,secondparagraphͲͲnomentionofnursesingroupofpeoplewhocanreport,doctors,hospitalsand
pharmacistsasanexample,butnursesareinnearconstantcontactwithpatients(90%ofthetime)and
arethemajorcaregivers,and,theyarethemostlikelytoreport.
p.3,havetobe18yearsorolder.Obviously,thisisforadults,butwhataboutchildren.Thereshouldbe
acommentthatthissystemcanbeusedbyanybodytoreportonanybody.Thesamethingshappento
childrenastoadults,sowhynotincludereportingofanyperson,includingchildren,byanadultorsome
personcapableofreporting.
2.Attachment“B”
p. 1, no need to program any pop up that says they’ve left something blank.  They need to put
something in each blank to show that they read the question and read the entire series of questions.
Suchas,puta*or–orn/aifitdoesnotapply.Somepeoplemayjustanswerafewquestionsandthe
reportwillbeunusable.
p.2,statementthatthereportshouldtakeabout 10Ͳ15minutesiscontradictedby theaverageof25
minutesonp.2oftheabovedocument.
p.6.Thereare6“wrongs”formedication,only2arelisted,and“somethingelse”isgiven,butIhaveno
ideaofthedropͲdownmenu.
p.9,3.5“bestguessisOK”??Importantinformationsuchasdayofweek,time(shiftchange),etc.would
behelpful
p.11,4.1medicaldevicenotmentioned
p.12,4.5“guessing”isnotOK’
p.17,5.1addNocommunicationforsquare#5andaddcontradictorycommunicationforsquareF
p.18,5.4.1addpatientadvocateforsquareF
p.20,6.2curiousaboutifyouarenotmaleorfemale,whatareyou?
p.20,6.2therearethousandsofpeopleover100,unlessyouhaveaspacelimitationallow3spaces
p.20,6.5
p.21,6.8addcellphoneat____andlaterusekioskasareportinglocation

p.22,6.9addtoitems:1)publicserviceradioorTVand2)educationalprogram
3.FAQs–inappropriatewording,allnegative,nothelpfultothe“patient”
Didnotmakespecificcommentsonthenext7of10sections.
IngeneralDrsSmithandMirelesdiscussedtheproposal:
1.ThetitleofthereportingsystemisConsumerReportingSystemforPatientSafety.Itwouldappear
that some consumer would be reporting for the patient, which is stated to be a doctor, pharmacist
(nurseleftoutinintroductorysection).
2. Consumer is a person who uses products, and needs tangible products for their welfare—food,
shelter,protection,etc.Oftheorganizations,servicesrepresent85+%ofGNPandproductsabout15%.
Theassumptionmadeinthesurveyisthathealthcareisaproduct.
Consumer,client,andpatientareinterchanged.Littlefocusontheuseoftheword“patient”.
Followingarefrom
3.4.1.hasfinallylistedmedicaldeviceonlyonce,anditneverappearsagain
4.nowaytolearniftheeventwasanearmiss
5.nowaytodetermineanythingpositivethatcouldbeusedforbestpractices
6.4.2“Whatkindofnegativeeffectdoesthepatientexperience”–physical,emotionalorboth???No
other categories.  If physical or both, then go to the laundry list of possibilities, i.e., breathing,
numbness, etc.  Emotional effect totally omitted from this category.   Illogical checking of boxes.
Section 5 now asks questions about why the negative affect or a mistake was made and what the
patient did afterwards. There is no possibility to report that if you have a medical mistake that you
wouldexperienceanegativeeffect
7.4.11ismisplacedshouldbethelastquestioninsection#5
8. Problem in numbering, Section 5, sequence as presented is 5.4 followed by 5.4.1, which is then
followedby5.4.
9.Accepted,standardU.S.censuscategoriesforracearenotused.Thesearestandard,easytolocate,
andusedinalllegitimatesurveysandotherresearcharenotusedforrace.Thesecategoriesappearin
allgovernmentresearch.
10.Medicalmistake,safetyconcern(medicalmistakeandinjuriesrelatedtohealthcare),andnegative
effects (harmed by medical care, such as infection, drug reaction, or complication) all used
interchangeably, adding to confusion in general.  Difficult for the patient to differentiate.  No
contributingfactorsincluded.




NotesFromMatthewMireles,PhD:
1.Globalinterpretation:format,structureandlogicforthequestionsintroduceinconsistency,andskip
patterns that are extremely confusing, i.e., 4.3 question some of the choices for responses should be
mutually exclusive, and they do not to eliminate confusion in the responses.  Where did the negative
effect first happen?: a) emergency department, b) hospital,  c)  doctor’s office in the clinic   (not
mutuallyexclusive).
2. It would be very difficult to crossͲreference a particular report to any other standard incident
reportingwithinthehospital.
3.Tremendousemphasisonphysicalnegativeeffects,verylittleaboutemotionaleffects.
4.Freetextboxallowance=100(what–charactersorwords?)
5. Totally omitted any data on actual harm or injury.  Did not ask what the injury was, as though all
injuries are the same.  They treat injury as injury, nothing more, with no question about severity,
disability,etc.Theonlyinjuriesyoucanhaveareinjurytoyoureyeoryourteeth,buthasadropͲdown
menuthatdoesnotincludeotherbodyparts.
6.Veryquestionableregardingvalidity(askingwhatreallyneedstobeasked)andhowinformationcan
be used with any thought of reliability (consistency).  Can’t match patient through crossͲreferencing.
Overlappingresponsecategories,notmutuallyexclusiveandconfusing.
7.ThecategoriesshouldbedefinedusingstandardAHRQnomenclature.Onpageswheretheremaybe
questions,definitionsshouldberepeated.
8.Recommendation:Sitdownwithrepresentativesfromhospitalsandpatientsandjustifyeverypiece
of information that they are trying to capture.  Some questions seemed bizarre and extraneous, and
needtocomparethistoothersystemstoaidintheunderstandingofanincident.
9.Restructuresomeoftheskippatternsandflowofthequestionnaire,whatcouldbedonetoprevent
thiswasmisplaced,andmorelogicalconstructionofthequestionswouldbehelpful.
10. Revisit every drop box responses provided for any particular question and based on standard
construction of questions, get your categories (not randomly) from sound documentation, do a
literaturesurvey.Ifresponsesaretomutuallyexclusive,seetheyaremutuallyexclusive.
11.Extremereliabilityandvalidityconcernregardingofwhatisreported.Ifcoulduseemailtocheckkey
questions, and the later telephone information is consistent (reliable).   There should have been a
concise premise and logic regarding exactly what the goal of the survey was.  There is no way to

determine whether there is a medical mistake and no harm.  Is this defined as a “near miss” this is a
technicality.Thenearmissmaybedefinedasanactualnegativeeffectonthepatient.
12.Therearenumerousotherobservationalcasescenarios,e.g.,nursesarguinginthehallway,thisisa
safetyconcern.Thinkyourdoctorisincompetentbeforesurgery.Hugeproblemwithnearmiss—can’t
separateorcapturethisinformation.

FromElizabethSmith,PhD:
1.Itisveryunlikelythisreportingsystemwillbeused.Patientswillobjecttotheinconsistencies,poor
formatting, redundancies, particularly the telephone survey.  No doctor will ever respond due to the
length.ThisisnocompetitorforKBCore/SOS.Toredothesedocumentswilltakeconsiderabletime,if
itisdoneatall.
2.Fromtheviewofsomeonewhohasextensiveexperienceonhowtocreatesurveys,testinstruments,
etc.,thesedocumentsarenotevenattheundergraduatelevel.





Community Medical Foundation for Patient Safety

The Community of Competence™ and Foundation for Life

MEDIA CONTACT:

NEWS RELEASE

Matthew C. Mireles, PhD, MPH
Community Medical Foundation for Patient Safety
6300 West Loop South, Suite 288
Bellaire, Texas 77401
Telephone: 832.778.7777; Fax: 832.778.7778
Email: [email protected]
Website: www.comofcom.com

FOR IMMEDIATE RELEASE

Patients Can Go Online to Record and Share their Most Recent
Medical Experiences

the course of 108 days

(BELLAIRE, TEXAS – June 1, 2010) The nonprofit Community Medical Foundation for Patient Safety, a
research group specializing in patient safety research and education, has partnered with CRG Medical,
Inc., an industry leader in health information technology based in Houston, to design and introduce a new
recording system specifically for patients and their families.
Share Our Stories© (SOS) emphasizes the need and importance of listening to patients and learning
from their wide range of experiences. Community Medical Foundation developed SOS in 2006 and
presented it to the National Patient Safety Foundation Congress almost one year before the National
Patient Safety Goal (NPSG) #13 was established to promote the engagement and participation of
patients and their families in their own health care. Despite NPSG #13 and other efforts, patients and
families rarely have a way to share their concerns and stories about an adverse event during the delivery
of their care.
CRG Medical, Inc. first developed and introduced KBCoreSM, an advanced web-based application to
record problems as they occur at the bedside and study adverse events and near misses to improve
patient safety and healthcare quality. As an Application Partner with InterSystems, CRG Medical, Inc.
provides the only system of its kind that uses Cache™ to integrate patient safety information within and
between hospital systems. CRG Medical, Inc. has provided the technical design and platform that make
SOS available and accessible to virtually everyone and every patient around the world. KBCore SOSSM
is the product of this partnership with Community Medical Foundation and now one of many outstanding
patient safety modules of KBCoreSM.

,
-- MORE --

Community Medical Foundation for Patient Safety

The Community of Competence™ and Foundation for Life

Page 2
When KBCore SOSSM went live, Douglas Dotan, President of CRG Medical, Inc., stated, “This is a major

from problems to adverse events and near misses can be consolidated and communicated from one seamless, single platform the
Medical
is an Application
with means
InterSystems
making the
KBCore䱐
platform
the only care.”
system ofEach
its kind
that
KBCore䱐.
stride in CRG
giving
all patients
a voicePartner
and the
to engage
and
participate
in health
year
uses Cache™ to integrate patient safety information in and between hospitals.

more than one million American patients are harmed by preventable medical errors, and more than
98,000 hospital patients died from these errors.

Founder of Community Medical Foundation Elizabeth A. Smith, PhD, also believes patients and families
have credible stories about their most recent experiences, good or bad, about our healthcare system that
must be recorded and studied. “Stories from patients and families can only enrich our knowledge of how
and why our system is failing and, perhaps, how it can be improved when these stories are coming from
the greatest stakeholders and the only true customers of health care,” according to Smith. Lisa Lindell, a
patient safety advocate and author of the book 108 Days commented, “If the auto and other industries are
listening to their customers and designing safer, better quality products and systems, why shouldn’t health
care do the same for patients?”
CRG Medical, Inc. provides the technical support for KBCore SOSSM, and Community Medical Foundation
analyzes each story for valuable information, such as important lessons learned or suggestions given by
patients. All stories will be used strictly for research and evaluation. No personal identifiers will be
disclosed or published. The information from this new patient safety recording system will be compiled
into the Foundation’s National Patient Safety Registry. A dedicated website has been set up at
https://sos.crgmedical.com/sos/app/comm/login.jsf. Patients and families who wish to share a recent
medical story or a suggestion for improvement may log on with username: patient and password: safety.
Interested hospitals may contact CRG Medical, Inc. (www.crgmedical.com) to obtain their unique login
account information for their patients.

###
About Community Medical Foundation for Patient Safety
Community Medical Foundation for Patient Safety, established in December 2003 as nonprofit 501 (c)(3) tax-exempt,
active learning organization based in the Houston area, is a leader in patient safety research and education. Our mission
is to promote and support patient safety through research, education, and the demonstrated practice of patient-centered
health care. On behalf of the Secretary of the U.S. Department of Health and Human Services, the Agency for
Healthcare Research and Quality has recognized and listed Community Medical Foundation for Patient Safety as Patient
Safety Organization #29.

CRGMedical
WebͲbasedHealthcareApplications

A Concern is always an Opportunity
before it becomes a Grievance

Confidential & Proprietary to CRG Medical Inc

From our conversation…
• Complaint / Grievance Process
Hunt currently uses multiple means of capturing and recording concern and or
complaint information
– Meditech is the primary modalities used by nursing staff
– Distribution, Escalation, ad progress tracking are largely manual driven processes
– Timeliness of response can make the difference between a concern being
addressed as a complaint or requiring more extensive and expensive handling as
a grievance per TJC/CMS requirements
–

• Current Request of CRG Medical
Demonstrate how current process can be electronically automated
– Demonstrate potential enhancements to process and system logic that can be
used to improve ease / effective capture, workflow tracking, alerts, transparency,
reporting, accountability, consolidation of documentation/analysis and recurrence
prevention.
–

Confidential & Proprietary to CRG Medical Inc

Included in this deck
• The Process of Capture
– Steps 1-4

• The Communication Process
• Step 5

• Ensuring Timely Follow-up and Documentation (as req)
– Routing
– Alerts
– Reporting
Confidential & Proprietary to CRG Medical Inc

HUNT REGIONAL MEDICAL CENTER

KBCore Complaint

Confidential & Proprietary to CRG Medical Inc

STEP ONE
•
•
•
•
•

1. What is Being Reported?
2. Summarize Complaint/Grievance
3. Immediate Actions Taken?
4. How could this be prevented in the future? (omit?)
5. How preventable was the event? (AHRQ code)(omit?)

Confidential & Proprietary to CRG Medical Inc

Step 2
Patient Information
• 6. Who was involved? ( ex patient /volunteer/visitor)
Last name First Name
Medical Record #
Date of birth
Gender (code)
At the time of the event, what was the age range? (code- non-patients)
Complaint/Grievance Received from:
Contact information if not a patient
Relationship: (code from form)

• 7. Name of attending physician: can be from a list (omit?)
• 8. If patient related, select unit or area where patient is housed/belongs.
(code)
• 9. Clinical service (code)

Confidential & Proprietary to CRG Medical Inc

Step 3
•
•
•
•
•

10. Event Unit (code)
11. Were any other departments involved? (code)
12. Date of Occurrence
13. Time of Occurrence
14. Specific location of occurrence, ex bedside, hallway
(code) (omit?)

Confidential & Proprietary to CRG Medical Inc

Step 4
• 15. Which of the following categories were associated
with the complaint? (code)
• 16. What were the factors that contributed to this
complaint? (code) (omit?)
• 17. Which of the following interventions were performed?
(code) Note: codes # 3
• Severity (extent of harm) (code)

Confidential & Proprietary to CRG Medical Inc

Step 5
Follow up actions for patient
• 18. What internal contacts were made? (code from form)
• Name of Physician Notified
• 19.What follow-up actions were taken? (code)
Reporter Information
• 20. Reporter's name
Report Date and time
• 21. Reporter's Job or Position (code)

Confidential & Proprietary to CRG Medical Inc

Follow-up Routing and Alerts
Supervisor
Routed to supervisor/ manager by selection of drop down list
Name date and time (documented by system)
• Comments
• Immediate Actions taken/ Additional Internal Contacts (updated)
• Resolution: code- Resolved/ Not resolved
–
Name
–
Date and Time
• Routed to other Department supervisor/manager and Service Excellence/ CNO by selection of drop down
list
Name Date and Time
note: comments in a shared space
• Routed to Director by selection of drop down list
–
Date
–
Sent by:
• ALERT sent to Director/CNO after 7 days no follow-up
Reminder letter by selection of drop down list
–
Date and Time
–
Sent by:

Confidential & Proprietary to CRG Medical Inc

Follow-up Routing and Alerts
Director Level
•
•

Comments
Resolution
–
Satisfactory, forwarded to CNO/CEO
•
Name Date and time
–
Unsatisfactory, returned to Dept
•
Name Date and time

•

Departmental Level Resolution
–
Name
–
Date and Time

•

Returned to Department for additional info by Director
–
Date
–
Sent by:

•

Resolution satisfactory after further investigation requested, issue forwarded to CNO/CEO
–
Name Date and time

•

ALERT sent to CNO after 7 days no follow-up from Director
Reminder letter by selection of drop down list
–
Name
–
Date
–
Sent by:

Confidential & Proprietary to CRG Medical Inc

Follow-up Routing and Alerts
CNO/CEO
• Findings (same as Meditech Statement of Resolution)
• Actions/Recommendations
– Issue Resolved, Forward to DQM
– Written Response Sent within 30 Days
– QC Subcommittee Convened
• Name
• Date and time

Confidential & Proprietary to CRG Medical Inc

Communication to Patient
• Letter to Patient/family of case pending if resolution not
possible within 7 days
– Name of person sending
– Department
– Date

• Letter to Patient/family of findings
– Name of person sending
– Department
– Date

Confidential & Proprietary to CRG Medical Inc

DQM Documentation
•
•
•
•
•
•

Complaint/Grievance Filed in Complaint Log
Patient & Family Complaint/Grievance Form Completed
Letter Sent to Patient/Family
Copy of completed form and response letter to DQM
DQM to report to QC, MEC and GB
Name Date and time for each

Confidential & Proprietary to CRG Medical Inc

Contact Information
www.crgmedical.com
Douglas Dotan
President and CEO

Anngail Smith
Director

[email protected]
+1.713.825.7900

[email protected]
+1.830.964.5326

CRG Medical, Inc.
2630 Fountain View Drive, Suite 408
Houston, Texas 77057
Confidential & Proprietary to CRG Medical Inc

CRGMedical
WebͲbasedHealthcareApplications

Design Process

Confidential & Proprietary to CRG Medical Inc

1. Automating the Paper Process

HRMC desktop Icon

Tell Me More

Tell Me More

Confidential & Proprietary to CRG Medical Inc

IHX Portal showing
• New entry
• Mgt Follow up
• Reporting etc

Initial Entry / Capture

Confidential & Proprietary to CRG Medical Inc

18

Initial Automatic Routing
Administrative Review

Add Alert to
new complaints

Add Alert if not
being addressed in
timely manner

Confidential & Proprietary to CRG Medical Inc

19

Response Review and
Acceptance

Add tracking
mechnisms (alert,
report, escalation)

Confidential & Proprietary to CRG Medical Inc

20

2. Future State Process

HRMC desktop Icon

Tell Me More

Tell Me More

Confidential & Proprietary to CRG Medical Inc

IHX Portal showing
• New entry
• Mgt Follow up
• Reporting etc

Flow Review Doc pg 1 of 2

Dept
Supvr/Mgr/Dir..
accesses
completed forms
via link

alert

Complaint
arises

Patient/Family/R
N/MD clicks
iHealthX Link on
mobile device or
PC

Forms go
to HRMC
iHealth X
account

iHealth X
Sends alert with
link to completed
form based on
config’d hierarchy
& Boolean Logic

alert

Service
Excellence
Patient Relations
Risk accesses init
form via link

Content of
SOS in iHealth
Form

Routed or
sharepoint
checkout

Content may
include std
response
letters, etc…

Initial Capture

alert

iHealth X
Sends data to
KBCore as
received

Dept.
Supvr/Mgr/Dir.
Routes to others?

all parties

Administration
accesses forms

Initial
entry

Confidential & Proprietary to CRG Medical Inc

Escalation
notification

New Forms
Review and
Or
Documentation
added
Updating of
if
Req’d
records if req’d
|
If response is timely and effective…
follow concern protocol vs. grievance protocol

Flow Review Doc pg 2 of 2

alert

Multiple records
merged in
KBCore as
received

KBCore Stores,
Analyzes,
Creates Report
and required
Follow-up

KBCore sends
combined info
(initial, combined,
response, et al)
back to IHealthX

iHealthX’s
hierarchy and
distribution
Logic drives
workflow
tracking

alert
Patient/F
amily

Dept
Supvr.

MD

SEC

RN

Adminis
tration

Alert + Report

alert
alert

Confidential & Proprietary to CRG Medical Inc

iHealthX
Exchange tracks
workflow

Alert + Report

CRGMedical
WebͲbasedHealthcareApplications

How it looks in real life

Confidential & Proprietary to CRG Medical Inc

So you have either seen (RN/MD) or experienced something (PT/Fam)
of concern, or have rec’d an alert (Supv/Mgr/Dir/CNO/SEC)…Log into
your page from cell or laptop

Confidential & Proprietary to CRG Medical Inc

25

Select App Tab based on who you are…

Confidential & Proprietary to CRG Medical Inc

26

Patients and Family…Start App to begin the
Info Capture

Confidential & Proprietary to CRG Medical Inc

27

Patient entry start point

Confidential & Proprietary to CRG Medical Inc

28

RN / MD entry start point

Confidential & Proprietary to CRG Medical Inc

29

Pull up Alerts

Confidential & Proprietary to CRG Medical Inc

30

Reporting on single or multiple criteria

Analytics on events
What
Where
Why
How Often
Recurrence

Analytics on Hospital Response
Degree - Concern/Complaint/Grievance
Timeliness
Effectiveness
Compliance
Impact
Confidential & Proprietary to CRG Medical Inc

31

Share Our Stories© (S.O.S.)
A Patient Safety Reporting System for anyone—patients, families and hospital staff
experiencing a recent medical event that caused harm or could have caused harm or
wanting to share a positive story or idea for safety.
You are not alone when you experience or observe a medical problem. You can share
your story, learn from others’ personal experiences, and save lives. Stories can be
negative about a medical error or positive recommendation about a new idea, tip or
suggestion to improve safety and quality of care.
The Share Our Stories© (SOS) created in 2006 is a new patient safety reporting
system for patients, families and hospital staff. SOS is completely anonymous. It is
administered by an independent nonprofit neutral party dedicated to patient safety.
SOS reports will be collected, studied, and shared with others. All patients admitted
to the hospital will receive a unique patient identification number and a password to
access SOS. Patients are encouraged to use SOS to share their stories electronically
on the hospital’s computer system or approved handheld device. For more
information about SOS, please contact your doctor, nurse or case manager
River Oaks Hospital
Patient Safety Committee
4200 Twelve Oaks Drive
Houston, TX 77027
713.964.8724

Share Our Stories© (S.O.S.)
A Patient Safety Recording System for patients, families, hospital staff, and
volunteers who have had a recent medical experience that has caused harm or could
have caused harm or anyone who wants to share a positive story about or idea or tip
for safety. You are not alone when you experience or observe a medical problem.
You can share your story, learn from others’ personal experiences, and save lives.
Stories can be negative about a medical error or positive about a new idea or
suggestion to improve safety and quality of care.
SOS is completely anonymous. It is developed and administered by the independent
nonprofit organization Community Medical Foundation for Patient Safety and used
since 2006. You may go online* to share your story with the username and password
at
https://sos.crgmedical.com/sos/app/comm/login.jsf.
Username: patient
Password: safety

It is important for everyone to share experiences about any problem, such as a
medical error, so we all can learn from this experience and prevent future
occurrences. Equally important are the stories with a good recommendation or tips
to improve safety and quality of care. SOS reports will be collected, studied, and
shared with others to improve best practices.
Community Medical Foundation for Patient Safety
6300 West Loop South, Suite 288
Bellaire, TX 77401
832.778.7777
[email protected]

*The online SOS Patient Safety Recording System is generously provided by our partner CRG Medical, Inc.
(www.crgmedical.com).

WHY PEP- the Patient Experience Program?
Physician practices require positive risk management and quality assurance programs as
well as complaint management systems for many reasons, including good patient/customer
relationships; minimization of loss, be it time, money or reputation; and the benefit of not
making mistakes, including the prevention of injury, the cost of re-work and employee
morale. Physicians have long employed RM briefings by their insurance companies, and
have developed policies and procedures for managing certain areas, such as HIPAA, billing
and medical records. Yet, many physician offices do not have an easy electronic means for
capturing information that could improve those programs and policies.
PEP, the Patient Experience Program.
In order to overcome this predicament we must first improve our understanding of these
events. It is, therefore, crucial to improve all types of event reporting, especially by busy
care providers. To do so, reporting must be:
x Easy and fast
x Confidential
x Provide a clear benefit to the reporter.
What do physicians and staff want to know? The short answer, how to make the right
decisions at the right time in the right way for the right person…. and to know when
those elements are NOT in place. There are three types of reports: first, any report from a
patient or family member to a staff person. Secondly, a direct report form the patient and
third an event or potential event reporting procedure.
PEP, the Patient Experience Program. is a unified set of modules for the collection and
analysis of safety event reports:
Complaint/Grievance Module, used by facility staff
Event Reporting Module, used by staff to report events and near misses
SOS ,Share Our Stories, used by patients to report positive or negative experiences
PEP uses a web and mobile application for easy reporting and feedback and includes a
health information exchange platform that enables secure communication between health
professionals, and organizations. Staff access each module via an IHE page, from a desktop
or mobile device, and progress quickly through the complaint and event modules. If wished,
the additional followup Steps are accessed by an email link sent only to those with
permissions to use the alert and routing system.
PEP was designed to
–Demonstrate how current process can be electronically automated
–Demonstrate potential enhancements to process and system logic that can be used to
improve ease / effective capture, workflow tracking, alerts, transparency, reporting,
accountability, consolidation of documentation/analysis and recurrence prevention.

Complaint and Grievance Reporting: the inpatient arena provides a model for complaint
reporting to a staff member, distinguishing between complaints and grievances, including
recognition of the failure to resolve a complaint within a reasonable time frame. Complaints
include a letter indicating treatment was unsatisfactory resulting in too many office visits,
letters re: rude staff, or the failure to recognize and act upon an abnormal lab finding
resulting in progression of disease, and can escalate to filing with the TSBME. Timely
documentation of complaints with follow-up at the proper level can minimize the number of
complaints as well as their severity.
Event Reporting: … the opportunity for mis- and missed diagnosis looms large in the out
patient setting even though it may occur infrequently. While small in number, sometimes
the flow of care can go quite badly. Patients are lost to followup, xray and lab findings are
missed, patients family members or visitors fall on the office. Insurance companies define
what events must be reported, however, documenting near misses and hazardous situations
allows analysis of what went right as well as what went wrong.
Health Information Exchange – Secure communication and professional social
networking
KBCore has partnered with iHealth exchange, a healthcare communication platform which
is endorsed, governed, and secured by the Texas Health Services Authority - iHealth Trust.
Once a safety event is identified, KBCore uses the iHealth system to notify the relevant
stakeholders and collect the necessary information from the reporter.
Apart from securing all the data collections in our system, iHealth exchange provides a safe
environment where reporters, safety officers and other officials can exchange information
regarding safety events. It is like a secure facebook for health professionals. A user can post
a message on the wall asking their colleagues for advice, or use the Direct-project NWHIN
email service to correspond with the safety officer or the PSO to provide additional details.
These safe communication capabilities increase the sense of confidentiality and provide a
utility from the system that is beyond reporting.
Reporting must be confidential – PEP provides an added level of confidentiality beyond
the liability protection of the PSO. It addresses the reporters’ fear of exposure to colleagues
and superiors by allowing reporting under a group. Compared to the existing option of an
anonymous report, group reporting conserves important information about the location of
the event and properties of the reporter. In addition, by partnering with iHealth Exchange,
an endorsed and supervised Health Information Exchange platform, we are able to provide
secure communication capabilities and ensure data security will not be breached.

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comments on Consumer Reporting System for Patient Safety
Tuesday, November 13, 2012 9:22:50 AM
image002.png
CRSPS Comments_11_9_2012.pdf

From: Becky Miller [mailto:[email protected]]
Sent: Friday, November 09, 2012 5:23 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comments on Consumer Reporting System for Patient Safety

Please accept the attached comments per the Federal Register posting of September 10, 2012.
Thank you.
Becky Miller ,

MHA, CPHQ, FACHE

EXECUTIVE DIRECTOR

CENTER FOR PATIENT SAFETY
O:888.935.8272 | C:573.230.5527 | F:573.636.8608
2410A HYDE PARK | JEFFERSON CITY, MO
[email protected] | www.centerforpatientsafety.org

This communication, including any attachments, may contain confidential information and is intended only for the individual or entity to
which it is addressed. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or taking
of any action in reliance on the contents of this information is strictly prohibited. If you are not the intended recipient, please call the
sender immediately and delete and destroy all copies of the original message.

2410A HYDE PARK ROAD
J E F FE R SO N C I T Y , M I S SO U R I
573.636.1014 (office)
888.935.827(toll free)
5 7 3 . 6 3 3 . 8 6 0 8 ( f a x)
@ P t Sa f e t y E x p e r t
www.centerforpatientsafety.org

November 9, 2012
Doris Lefkowitz
Reports Clearance Officer
Agency for Healthcare Research and Quality
Department of Health and Human Services
540 Gaither Road
Rockville, MD 20850
Re: Response to Federal Register Request for Comments on a Prototype Consumer Reporting
System for Patient Safety Events
Dr. Ms. Lefkowitz:
Thank you for the opportunity to comment on the Monday, September 10, 2012 Federal Register
notice pertaining to the Agency’s Proposed Project, Prototype Consumer Reporting System for
Patient Safety (CRSPS) Events.
We concur with the following issues that were raised in the Federal Register posting:
x consumers are in a position to view their own care and that of loved ones from a broad
spectrum over the continuum of care not possible for individual providers
x information from consumers could be beneficial to better understanding of the breadth of
medical mistakes and near misses that occur within healthcare delivery
x not all adverse medical events are reported through current systems
x there is no consistent system to obtain reports from patients and families across the nation
x any proposed consumer event reporting system should be thoroughly evaluated and
tested, and include input from federally-designated Patient Safety Organizations (PSOs)
x the collection of information from consumers should be standardized and it is reasonable
to utilize the AHRQ-developed Common Data Format that are currently utilized by PSOs
We submit the following questions and comments for consideration as the testing and research of
a consumer event reporting system moves forward:
x We believe that providers will be aware of many of the issues reported through the
proposed CRSPS, many designated as Patient Safety Work Product within the provider’s
Patient Safety Evaluation System, protected from disclosure by the Patient Safety and
Quality Improvement Act of 2005 (Act). How can discussions occur between the CRSPS
staff and providers on event data and information that is PSWP within the provider’s
PSES without the provider violating the Act?
x The CRSPS should support the continued improvement of the safety culture that
encourages reporting of adverse events; if the system is perceived as punitive in any way

2410A HYDE PARK ROAD
J E F FE R SO N C I T Y , M I S SO U R I
573.636.1014 (office)
888.935.827(toll free)
5 7 3 . 6 3 3 . 8 6 0 8 ( f a x)
@ P t Sa f e t y E x p e r t
www.centerforpatientsafety.org

x

x

x

or result in potential legal action or compliance or financial penalties, positive work over
the recent decade to improve safety culture could be circumvented.
We believe the estimate of patients who will give permission for CRSPS staff follow-up
is underestimated. Most patients who report events do so to obtain follow-up and
resolution; therefore much more than ten percent will likely permit CRSPS to follow-up.
What organization will provide the follow-up? Will the organization and its designated
staff be authorized to have access to a providers’ PSWP? CRSPS staff should have a
strong skill set and understanding of provider and patient safety evaluation processes.
We believe the estimate of provider time required for CRSPS follow-up is
underestimated. CRSPS events that the provider is not aware of will require a
comprehensive review of documentation, interviews and following provider policy for
event evaluation and reporting requiring much more than 20 minutes. Follow-up will
also require providers to evaluate documentation and information as it pertains to their
PSO reporting of PSWP and what can be discussed with CRSPS staff, likely requiring
addition time and expense from legal consultation. Consideration should also be given to
how CRSPS reports will be evaluated to ensure only legitimate concerns are submitted
for provider follow-up.
The CRSPS should not circumvent or duplicate provider efforts to comply with the CMS
and Joint Commission requirements: CFR 482.13, CMS Conditions of Participation
requires every hospital to have a grievance program for patients/family members to file
complaints. The Joint Commission requires accredited providers to have a complaint
process in place (RI.01.07.01).

Again, thank you for the opportunity to provide these comments and questions.
Sincerely,

Becky Miller, MHA, CPHQ, FACHE
Executive Director

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Consumer comments on A prototype consumer reporting system for patient safety events
Tuesday, November 13, 2012 9:21:39 AM
Patient Reporting comments to AHRQ FINAL 11-9-12.docx

From: Lisa McGiffert [mailto:[email protected]]
Sent: Friday, November 09, 2012 6:57 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Consumer comments on A prototype consumer reporting system for patient safety events

Dear Doris Lefkowitz:
We appreciate the opportunity to respond to AHRQ’s proposal to test a model for consumer
reporting of medical errors through the creation of “A prototype consumer reporting system
for patient safety events” as posted in the Federal Register (September 10, 2012, pp. 5547555477).
As consumer advocates for safer health care (signatures below), we believe that gathering
information from patients who have been harmed while receiving health care is a great idea one that consumer advocates have suggested for years.
An estimated one in four patients is harmed when hospitalized – yet the oversight of medical
harm is weak, underfunded and often hidden from public view. Our nation’s response system
to this leading cause of death in America fails patients every day through an unwillingness to
approach this problem with urgency and accountability. The recent Hepatitis C and
meningitis outbreaks are illustrations of a system clearly unable to respond adequately to
protect patients.
Incidences of medical harm rarely are reported. A recent memorandum report by the Office
of Inspector General, Department of HHS, found that in states that required reporting of
certain medical errors, hospitals only reported one percent of these events. Most of the events
that States required to be reported, but that hospitals did not report, were not identified by
internal hospital incident reporting systems -- the staff did not view them as reportable
events, even though some of them resulted in patient deaths. Although this is only one of
many studies that have found significant underreporting of medical errors by hospitals, it
highlights the need to bring patients’ reports into the mix of identifying harm that is
occurring in our health care system.
In general, we fully support the concept of consumer reporting of medical errors. We assume
the results of this pilot will be used to design a system that could be used on a broader scale.
In the future, patients should play a more meaningful role in reporting medical harm through
a system that is sustainable and provides a benefit to those patients and the public.
We have reviewed the Federal Register notice and all of the accompanying attachments and
have some concerns, comments and recommendations regarding the details of this
demonstration project. Our three priority concerns are the lack of public transparency, the
lack of a clear goal to benefit patients and diversion of patients from filing complaints with
agencies that have statutory oversight of hospitals, clinics and physicians.

Public transparency. We believe public reporting is an essential component to improve
patient safety and an essential part of that is to connect the harm with the providers. Many of
us worked to establish hospital infection reporting systems in our states and are keenly aware
of the impact that publishing infection rates has had in motivating hospitals to improve
patient safety, reducing infections and saving lives.
While this project plans to only produce aggregated reports, our review of all of the
accompanying documents finds no reference to providing those reports to the patients who
helped to create them or to the public. Instead, the aggregated reports are to be given to
“doctors, hospitals, and pharmacists so they can make health care safer.” The public should
also have access to these reports. Further, the project should build in a process by which all
patients who submit reports about their personal experiences will be notified when the
aggregate report is completed and provided with directions on how to access that report.
Goals of the system: The three stated goals of this demonstration project are:
1. To develop and design a prototype system to collect information about patient safety
events.
2. To develop and test Web and telephone modes of a prototype questionnaire.
3. To develop and test protocols for a follow-up survey of health care providers.
We are concerned that there is no goal to follow up with the patients. Clearly this project
recognizes the importance of collecting information from patients who have been harmed, but
in reviewing the details, there is no recognition of patients’ rights to know what happened to
them and why. This is fundamentally what most harmed patients want to find out. The
proposal estimates that only a small number of patients will agree to have their information
shared with the providers involved. These patients are taking some risks in doing so and
deserve to be fully included in the “experiment” of using their information to make their
providers practice safer health care. The patients should be informed regarding the providers’
responses and regarding any positive outcomes that resulted from their disclosure (e.g., the
provider changed a particular practice to ensure similar errors don’t happen in the future).
We recommend adding a fourth goal: To develop and test protocols for providing follow up
to patients who have filed reports.
Diverting medical error reports from regulatory agencies. If our system of oversight
really worked, patients would be well informed about where to file reports when they have
witnessed or experienced safety problems, the regulatory agency would investigate the report
and some kind of corrective action would occur. Instead, the health care system’s response to
medical errors has condoned secrecy, avoided addressing underlying safety problems and left
patients and their families with terrible losses and huge medical bills. While we acknowledge
that our health care oversight systems are lacking, we believe more attention should be
directed at improving them.
What we really need is a public awareness campaign to inform harmed patients about how to
file complaints against hospitals and doctors. A 2011 Consumers Union national randomized
poll found that only one-quarter of respondents said they would know where to file a
complaint about a medical error they experienced at a hospital.
Creating a completely separate consumer reporting system – one that promises no tangible

accountability or help to consumers of health care – might not be the most effective way to
engage patients in improving care. Every state and federal programs like Medicare have
systems in place to collect and investigate consumer complaints. Our concern is that people
participating in the pilot project will be misled to believe this survey is an official reporting
process that will lead to some kind of resolution to the incidents of medical harm. Harmed
patients need their problems addressed -- analyzing their reports privately with their
providers and aggregately reporting the information to other providers won’t help them and
might not effectively identify the providers with the biggest problems.
To address this issue, we recommend that the project proactively inform and guide patients to
the appropriate agencies that license hospitals, doctors, etc., for reporting what happened to
them. This would make the project’s role perfectly clear, while bolstering our oversight
system with information it needs to identify providers who may not be doing enough to
ensure that patients are safe.
Other comments:
v The method of outreach for testing this prototype at a local level appears to be a good
plan. Creating a community-based marketing campaign and handing the flyer (which is
direct and understandable) to patients at several points in their discharge and follow up
process provide the repetition that might encourage more of them to participate. We are
concerned though, how this approach will translate into a national system. While it may
work at a local level, with full agreement with the hospitals to help with this outreach, it
will be a significant challenge to implement on a broader scale.

v The project should recognize that many of these patients are still under the care of the
providers who may have caused them harm and speaking up could result in retaliation.
We didn’t see any discussion about how to protect against or respond to such actions. We
recommend that the project develop a written strategy for protecting against retaliatory
actions in a way that makes the patient the priority and not the provider and for
responding to such acts when they occur.

v Creating two new euphemisms for medical harm –“health care safety concern”
and “negative effect” – is unnecessarily confusing. Neither terms are widely used
and may have little meaning to the general public or health care providers.
Further, we consider these to be “soft” terms and paired with some of the other
descriptive text in the accompanying documents, they tend to minimize the
impact or experience of medical errors. For example: “A safety concern is
anything that happens with your doctor or hospital or pharmacy that worries you
because you think it isn’t safe. It does not have to be something that resulted in
harm. Maybe nothing bad happened but there was almost a mistake—we call
this a ‘near miss.’” Seeking information from someone whose child just died by
asking if they were “concerned” or “worried” is inappropriate. Is the project
seeking people’s “safety concerns” or is it trying to find out about harm and
injury that patients experience in the process of receiving health care? Too often
the language used in the documents that patients will see fails to appropriately
reflect the seriousness of these experiences. In 2011 Consumers Union

conducted a survey on patient safety, which asked among other things for
consumers to choose the terms that best describe preventable problems that
occur when receiving medical care. Only three terms were singled out by more
than 1 in 10 consumers: Medical error, Medical mistake and Treatment error. We
recommend that the project use one common term consistently rather
than make up completely new terms that are not commonly used.

v One of the goals of the project appears to be to provide real life local examples of
harm to providers rather than attempt to accumulate some kind of record of the harm that
is happening in a particular town. Clearly most of the patient reports will not be
identifiable or shared with the providers involved with the error, rather they will be
incorporated into aggregate reports that are not made public. We believe there are much
more efficient, less costly ways to provide these types of anonymous examples of medical
harm to providers.

v Most of the descriptive text in all of the attachments (such as the scripts for phone
calls, FAQs, and introductory explanations) highlights that specific patient information
will not be offered to the doctor or hospital. This claim is made repeatedly throughout the
documents, for example: “We will only tell doctors, hospitals, and pharmacists a
compilation of what we learn; no individual reports are shared. We hope they will make
changes and that health care will be safer;” “I give my permission to the CRSPS team to
use my information as long as they do not share my name and other identifying
information.” The project’s intention to ask patients for permission to share their
identifiable information with their providers only appears in a few places: in the middle
of the survey and in a statement in Attachment A (website intro): “I understand my
individual answers to the survey questions are strictly confidential and will not be seen by
anyone outside the CRSPS team, unless during the reporting process I agree to allow the
CRSPS team to share this information.” The FAQ document mentions nothing about
giving the patients specific information to the providers involved in their care. It
thoroughly covers the issues of confidentiality of all of the information provided but fails
to discuss the option to share identifiable information. We believe people will be less
likely to trust the project if, after repeatedly reading about how their information will not
be shared, they are surprised with asking them to share their personal information to with
the providers who caused the harm. We recommend that language similar to that cited
above from Attachment A be incorporated into other statements about confidentiality.

v We have some concerns with non-government entities that are relatively unknown to
consumers as the collectors and the repository for a consumer reporting system for errors.
We think most people would be more comfortable and would report more readily to a
government agency than they would to an entity they've never heard of. This should be
carefully considered when a broader national system is created. Government agencies are
not perfect and may be subject to political pressure, but in the long run we think people
would trust that AHRQ, for example, would be more likely to be independent, not be
influenced by industry and act in the public interest than employees of a group in the
private sector.

Specific Feedback about the web survey tool (attachment B): While we are not providing
an exhaustive critique of the survey tool, we have a few comments that we think should be
addressed:
v Questions 3.7 and its follow up are too simplistic. 3.7 asks: “Did a doctor, nurse, or
other health care provider make any special effort to help the patient handle the mistake?
” If the patient answers “yes,” the follow up question (3.7.1) asks: Did it help?
Yes/no/don't know. We recommend adding a box to this question (or more choices) so
the patient can provide more information as to the kind of “help” that was offered and
why it did or didn’t help. Questions 4.8 and 4.81 repeat these questions.
v Questions 3.6 and 4.7 ask: “How did the patient find out that the mistake happened?”
but do not offer limited choices regarding the outcome of the mistake. For example,
adding an option to indicate that the patient “found out” about the mistake because the
patient died or was disabled or harmed. Instead the responses given in the current survey
are more in line with minor concerns, such as asking when and how someone “noticed”
the mistake. While we like that a text box is included to enable the consumer to give more
information, we think it would help to add at least one more choice indicating that they
became aware of the mistake because of death or incapacitation – omitting the recognition
that people often find out about mistakes when they become seriously ill seems to be an
obvious oversight.

We look forward to seeing the results of this experiment, but believe the optimal direction for
national patient reporting is through a system similar to that used to gather HCAHPS surveys.
It would not depend on volunteers and the results would be public with the identity of the
hospital or physician included. Ultimately, to eliminate medical harm, we need a publicly
accessible system that integrates all sources of information being collected about health care
safety to reveal a full picture of a provider’s safety record – that would include patient
reports, reports by providers on outcome measures (e.g., health care-acquired infections,
hospital acquired conditions), licensing agency records and inspections, accreditation reports,
and medical malpractice settlements. Assessing patient safety in silos allows providers with
the biggest problems that need the most help for improvement and accountability to go
undetected.
Sincerely,
Lisa McGiffert
Director, Consumers Union Safe Patient Project
[email protected]
512-477-4431 ext 115
Kathy Day RN
Patient Safety Activist
McCleary MRSA Prevention
Bangor, ME
[email protected]

Patty and David Skolnik
Co-founders
Citizens for Patient Safety
Denver, CO
www.citizensforpatientsafety.org
Alicia Cole
Alliance for Safety Awareness for Patients
http://patientsafetyasap.org/
Los Angeles, CA
[email protected]
Dan Walter
DeLand, FL
[email protected]
Martha Deed, Ph.D.
Psychologist (ret) and Patient Advocate
North Tonawanda, NY
[email protected]
Julia Hallisy, D.D.S.
Founder and President
The Empowered Patient Coalition
San Francisco, CA
[email protected]
Robert E. Oshel, Ph.D.
Retired Associate Director for Research and Disputes, National Practitioner Data Bank
Silver Spring, MD
[email protected]
Lenore Alexander
Oak Park, CA
[email protected]
Lisa Freeman
CT Center for Patient Safety
Fairfield, CT
[email protected]
Pat Mastors
Patient Advocate
Patient/Family Advisor, Partnership for Patients
President, CEO
Pear Health LLC
East Greenwich, RI
[email protected]
Mary Brennan-Taylor

Patient Safety Advocate
Adjunct Research Instructor, University at Buffalo, Department of Family Medicine
Lockport, New York
[email protected]
Lori Nerbonne
NH Patient Voices
Bow, NH
[email protected]
Joleen Chambers
Dallas, TX
http://fida-advocate.blogspot.com
Alan Levine
Health Care Advocate
Washington, D.C.
[email protected]
-Lisa McGiffert
Consumers Union
Safe Patient Project
www.SafePatientProject.org
512-477-4431 ext 115
[email protected]
When he makes a mistake, he realizes it. Having realized it, he admits it. Having admitted it,
he corrects it.
--- Tao te Ching, Ch 61

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[email protected]
We appreciate the opportunity to respond to AHRQ’s proposal to test a model for
consumer reporting of medical errors through the creation of “A prototype consumer
reporting system for patient safety events” as posted in the Federal Register (September
10, 2012, pp. 55475-55477).
As consumer advocates for safer health care, we believe that gathering information from
patients who have been harmed while receiving health care is a great idea - one that
consumer advocates have suggested for years.
An estimated one in four patients is harmed when hospitalized – yet the oversight of
medical harm is weak, underfunded and often hidden from public view. Our nation’s
response system to this leading cause of death in America fails patients every day
through an unwillingness to approach this problem with urgency and accountability. The
recent Hepatitis C and meningitis outbreaks are illustrations of a system clearly unable
to respond adequately to protect patients.
Incidences of medical harm rarely are reported. A recent memorandum report by the
Office of Inspector General, Department of HHS, found that in states that required
reporting of certain medical errors, hospitals only reported one percent of these events.
Most of the events that States required to be reported, but that hospitals did not report,
were not identified by internal hospital incident reporting systems -- the staff did not
view them as reportable events, even though some of them resulted in patient deaths.
Although this is only one of many studies that have found significant underreporting of
medical errors by hospitals, it highlights the need to bring patients’ reports into the mix
of identifying harm that is occurring in our health care system.
In general, we fully support the concept of consumer reporting of medical errors. We
assume the results of this pilot will be used to design a system that could be used on a
broader scale. In the future, patients should play a more meaningful role in reporting
medical harm through a system that is sustainable and provides a benefit to those
patients and the public.
We have reviewed the Federal Register notice and all of the accompanying attachments
and have some concerns, comments and recommendations regarding the details of this
demonstration project. Our three priority concerns are the lack of public transparency,
the lack of a clear goal to benefit patients and diversion of patients from filing
complaints with agencies that have statutory oversight of hospitals, clinics and
physicians.
Public transparency. We believe public reporting is an essential component to
improve patient safety and an essential part of that is to connect the harm with the
providers. Many of us worked to establish hospital infection reporting systems in our
states and are keenly aware of the impact that publishing infection rates has had in
motivating hospitals to improve patient safety, reducing infections and saving lives.

1

While this project plans to only produce aggregated reports, our review of all of the
accompanying documents finds no reference to providing those reports to the patients
who helped to create them or to the public. Instead, the aggregated reports are to be
given to “doctors, hospitals, and pharmacists so they can make health care safer.” The
public should also have access to these reports. Further, the project should build in a
process by which all patients who submit reports about their personal experiences will
be notified when the aggregate report is completed and provided with directions on how
to access that report.
Goals of the system: The three stated goals of this demonstration project are:
1. To develop and design a prototype system to collect information about patient
safety events.
2. To develop and test Web and telephone modes of a prototype questionnaire.
3. To develop and test protocols for a follow-up survey of health care providers.
We are concerned that there is no goal to follow up with the patients. Clearly this
project recognizes the importance of collecting information from patients who have been
harmed, but in reviewing the details, there is no recognition of patients’ rights to know
what happened to them and why. This is fundamentally what most harmed patients
want to find out. The proposal estimates that only a small number of patients will agree
to have their information shared with the providers involved. These patients are taking
some risks in doing so and deserve to be fully included in the “experiment” of using their
information to make their providers practice safer health care. The patients should be
informed regarding the providers’ responses and regarding any positive outcomes that
resulted from their disclosure (e.g., the provider changed a particular practice to ensure
similar errors don’t happen in the future).
We recommend adding a fourth goal: To develop and test protocols for providing follow
up to patients who have filed reports.
Diverting medical error reports from regulatory agencies. If our system of
oversight really worked, patients would be well informed about where to file reports
when they have witnessed or experienced safety problems, the regulatory agency would
investigate the report and some kind of corrective action would occur. Instead, the
health care system’s response to medical errors has condoned secrecy, avoided
addressing underlying safety problems and left patients and their families with terrible
losses and huge medical bills. While we acknowledge that our health care oversight
systems are lacking, we believe more attention should be directed at improving them.
What we really need is a public awareness campaign to inform harmed patients about
how to file complaints against hospitals and doctors. A 2011 Consumers Union national
randomized poll found that only one-quarter of respondents said they would know
where to file a complaint about a medical error they experienced at a hospital.
Creating a completely separate consumer reporting system – one that promises no
tangible accountability or help to consumers of health care – might not be the most
effective way to engage patients in improving care. Every state and federal programs
like Medicare have systems in place to collect and investigate consumer complaints. Our

2

concern is that people participating in the pilot project will be misled to believe this
survey is an official reporting process that will lead to some kind of resolution to the
incidents of medical harm. Harmed patients need their problems addressed -- analyzing
their reports privately with their providers and aggregately reporting the information to
other providers won’t help them and might not effectively identify the providers with the
biggest problems.
To address this issue, we recommend that the project proactively inform and guide
patients to the appropriate agencies that license hospitals, doctors, etc., for reporting
what happened to them. This would make the project’s role perfectly clear, while
bolstering our oversight system with information it needs to identify providers who may
not be doing enough to ensure that patients are safe.
Other comments:
• The method of outreach for testing this prototype at a local level appears to be a
good plan. Creating a community-based marketing campaign and handing the flyer
(which is direct and understandable) to patients at several points in their discharge
and follow up process provide the repetition that might encourage more of them to
participate. We are concerned though, how this approach will translate into a
national system. While it may work at a local level, with full agreement with the
hospitals to help with this outreach, it will be a significant challenge to implement on
a broader scale.
•

The project should recognize that many of these patients are still under the care of
the providers who may have caused them harm and speaking up could result in
retaliation. We didn’t see any discussion about how to protect against or respond to
such actions. W e recom m end that the project develop a w ritten strategy for

protecting against retaliatory actions in a w ay that m akes the patient the
priority and not the provider and for responding to such acts w hen they
occur.

•

Creating two new euphemisms for medical harm –“health care safety concern” and
“negative effect” – is unnecessarily confusing. Neither terms are widely used and
may have little meaning to the general public or health care providers. Further, we
consider these to be “soft” terms and paired with some of the other descriptive text
in the accompanying documents, they tend to minimize the impact or experience of
medical errors. For example: “A safety concern is anything that happens with your
doctor or hospital or pharmacy that worries you because you think it isn’t safe. It
does not have to be something that resulted in harm. Maybe nothing bad happened
but there was almost a mistake—we call this a ‘near miss.’” Seeking information
from someone whose child just died by asking if they were “concerned” or “worried”
is inappropriate. Is the project seeking people’s “safety concerns” or is it trying to
find out about harm and injury that patients experience in the process of receiving
health care? Too often the language used in the documents that patients will see
fails to appropriately reflect the seriousness of these experiences. In 2011
Consumers Union conducted a survey on patient safety, which asked among other
things for consumers to choose the terms that best describe preventable problems
that occur when receiving medical care. Only three terms were singled out by more

3

than 1 in 10 consumers: Medical error, Medical mistake and Treatment error. W e

recom m end that the project use one com m on term consistently rather
than m ake up com pletely new term s that are not com m only used.
•

One of the goals of the project appears to be to provide real life local examples of
harm to providers rather than attempt to accumulate some kind of record of the
harm that is happening in a particular town. Clearly most of the patient reports will
not be identifiable or shared with the providers involved with the error, rather they
will be incorporated into aggregate reports that are not made public. We believe
there are much more efficient, less costly ways to provide these types of anonymous
examples of medical harm to providers.

•

Most of the descriptive text in all of the attachments (such as the scripts for phone
calls, FAQs, and introductory explanations) highlights that specific patient
information will not be offered to the doctor or hospital. This claim is made
repeatedly throughout the documents, for example: “We will only tell doctors,
hospitals, and pharmacists a compilation of what we learn; no individual reports are
shared. We hope they will make changes and that health care will be safer;” “I give
my permission to the CRSPS team to use my information as long as they do not
share my name and other identifying information.” The project’s intention to ask
patients for permission to share their identifiable information with their providers
only appears in a few places: in the middle of the survey and in a statement in
Attachment A (website intro): “I understand my individual answers to the survey
questions are strictly confidential and will not be seen by anyone outside the CRSPS
team, unless during the reporting process I agree to allow the CRSPS team to share
this information.” The FAQ document mentions nothing about giving the patients
specific information to the providers involved in their care. It thoroughly covers the
issues of confidentiality of all of the information provided but fails to discuss the
option to share identifiable information. We believe people will be less likely to trust
the project if, after repeatedly reading about how their information will not be
shared, they are surprised with asking them to share their personal information to
with the providers who caused the harm. W e recom m end that language sim ilar

to that cited above from Attachm ent A be incorporated into other
statem ents about confidentiality.

•

We have some concerns with non-government entities that are relatively unknown to
consumers as the collectors and the repository for a consumer reporting system for
errors. We think most people would be more comfortable and would report more
readily to a government agency than they would to an entity they've never heard
of. This should be carefully considered when a broader national system is created.
Government agencies are not perfect and may be subject to political pressure, but in
the long run we think people would trust that AHRQ, for example, would be more
likely to be independent, not be influenced by industry and act in the public interest
than employees of a group in the private sector.

Specific Feedback about the web survey tool (attachment B): While we are not
providing an exhaustive critique of the survey tool, we have a few comments that we
think should be addressed:

4

•

•

Questions 3.7 and its follow up are too simplistic. 3.7 asks: “Did a doctor, nurse, or
other health care provider make any special effort to help the patient handle the
mistake?” If the patient answers “yes,” the follow up question (3.7.1) asks: Did it
help? Yes/no/don't know. We recommend adding a box to this question (or more
choices) so the patient can provide more information as to the kind of “help” that
was offered and why it did or didn’t help. Questions 4.8 and 4.81 repeat these
questions.
Questions 3.6 and 4.7 ask: “How did the patient find out that the mistake
happened?” but do not offer limited choices regarding the outcome of the mistake.
For example, adding an option to indicate that the patient “found out” about the
mistake because the patient died or was disabled or harmed. Instead the responses
given in the current survey are more in line with minor concerns, such as asking
when and how someone “noticed” the mistake. While we like that a text box is
included to enable the consumer to give more information, we think it would help to
add at least one more choice indicating that they became aware of the mistake
because of death or incapacitation – omitting the recognition that people often find
out about mistakes when they become seriously ill seems to be an obvious
oversight.

We look forward to seeing the results of this experiment, but believe the optimal
direction for national patient reporting is through a system similar to that used to gather
HCAHPS surveys. It would not depend on volunteers and the results would be public
with the identity of the hospital or physician included. Ultimately, to eliminate medical
harm, we need a publicly accessible system that integrates all sources of information
being collected about health care safety to reveal a full picture of a provider’s safety
record – that would include patient reports, reports by providers on outcome measures
(e.g., health care-acquired infections, hospital acquired conditions), licensing agency
records and inspections, accreditation reports, and medical malpractice settlements.
Assessing patient safety in silos allows providers with the biggest problems that need
the most help for improvement and accountability to go undetected.
Sincerely,
Lisa McGiffert
Director, Consumers Union Safe Patient Project
[email protected]
512-477-4431 ext 115
Kathy Day RN
Patient Safety Activist
McCleary MRSA Prevention
Bangor, ME
[email protected]
Patty and David Skolnik
Co-founders
Citizens for Patient Safety

5

Denver, CO
www.citizensforpatientsafety.org
Alicia Cole
Alliance for Safety Awareness for Patients
http://patientsafetyasap.org/
Los Angeles, CA
[email protected]
Dan Walter
DeLand, FL
[email protected]
Martha Deed, Ph.D.
Psychologist (ret) and Patient Advocate
North Tonawanda, NY
[email protected]
Julia Hallisy, D.D.S.
Founder and President
The Empowered Patient Coalition
San Francisco, CA
[email protected]
Robert E. Oshel, Ph.D.
Retired Associate Director for Research and Disputes, National Practitioner Data Bank
Silver Spring, MD
[email protected]
Lenore Alexander
Oak Park, CA
[email protected]
Lisa Freeman
CT Center for Patient Safety
Fairfield, CT
[email protected]
Pat Mastors
Patient Advocate
Patient/Family Advisor, Partnership for Patients
President, CEO
Pear Health LLC
East Greenwich, RI
[email protected]
Mary Brennan-Taylor
Patient Safety Advocate
Adjunct Research Instructor, University at Buffalo, Department of Family Medicine
6

Lockport, New York
[email protected]
Lori Nerbonne
NH Patient Voices
Bow, NH
[email protected]
Joleen Chambers
Dallas, TX
http://fida-advocate.blogspot.com
Alan Levine
Health Care Advocate
Washington, D.C.
[email protected]

7

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Written Comments--Prototype Consumer Reporting System for Patient Safety Events (CRSPS)
Tuesday, November 13, 2012 9:19:36 AM

From: Lucy Savitz [mailto:[email protected]]
Sent: Friday, November 09, 2012 7:13 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Written Comments--Prototype Consumer Reporting System for Patient Safety Events (CRSPS)

I am writing on behalf of:
The Intermountain-led Hospital Engagement Network and
The University of Utah Center for Clinical and Translational Science, Community Engagement Core
In response to the call for public comment on CRSPS.
Overall, we are in support of this important tool to give voice to patients/families/caregivers in
identifying and promoting patient safety.
We believe that the system should provide sufficient detail to delivery systems that would afford
linkages to:
1. Link with clinical data to verify that an event occurred;
2. determine the type of event and a “score” (that currently does not exist) related to the
preventability and seriousness of the incident; and
3. Design national reporting that would stratify the types of events reported with specific
notations on those that had been vs. those that had not been verified.
Much of hospital resources are devoted to sentinel events and such a system would help elucidate
patterns in near misses and other preventable events to the benefit of overall patient safety.
Thank you for this opportunity to comment.
Lucy Savitz
Lucy A. Savitz, Ph.D., MBA
Project Director, Intermountain-led Hospital Engagement Network
Director, University of Utah CCTS Community Engagement Core
801-442-3049

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comments, AHRQ"s proposed ""A Prototype Consumer Reporting System for Patient Safety Events, ""
Federal Register /Vol. 77, No. 175 /Monday, September 10, 2012 /Notices, No Docket No. Provided.)
Friday, November 09, 2012 10:44:26 AM
ADVERSE.EVENTS.PATIENT.REPORTING.AHRQ.COMMENTS.11.9.2012.docx

From: Barry Furrow [mailto:[email protected]]
Sent: Friday, November 09, 2012 10:43 AM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Barry Furrow
Subject: RE: Comments, AHRQ’s proposed ‘‘A Prototype Consumer Reporting System for Patient Safety
Events, ’’ Federal Register /Vol. 77, No. 175 /Monday, September 10, 2012 /Notices, No Docket No.
Provided.)

Dear Ms. Lefkowitz:
I have resent our comments, this time with a full heading in the Subject box just in case your
spam filter has screened out my first submission.
Thank you.
Sincerely yours,
Barry R. Furrow
Professor of Law
Director, Health Law Program
Earle Mack School of Law
Drexel University
3320 Market Street
Philadelphia, PA 19104
Tel: 215.571-4706 | Cell: 610.998.5333| Fax: 215.571.4712
[email protected]
[email protected]

From: [email protected]
To: [email protected]
CC: [email protected]
Subject:
Date: Fri, 9 Nov 2012 10:38:58 -0500

Dear Ms. Lefkowitz:
You have requested comments on AHRQ’s proposed information collection project: ‘‘A
Prototype Consumer Reporting System for Patient Safety Events, ’’ Federal Register /Vol.
77, No. 175 /Monday, September 10, 2012 /Notices, No Docket No. Provided.)
We have attached our Comments to this email, in response to your request for comments.
If you have any questions, please feel free to email or call me, as the primary contact for

these comments.
Thank you.
Sincerely yours.
Barry R. Furrow
Professor of Law
Director, Health Law Program
Earle Mack School of Law
Drexel University
3320 Market Street
Philadelphia, PA 19104
Tel: 215.571-4706 | Cell: 610.998.5333| Fax: 215.571.4712
[email protected]
[email protected]

EARLE MACK SCHOOL OF LAW
Drexel University
BARRY FURROW
PROFESSOR OF LAW
DIRECTOR, THE HEALTH LAW PROGRAM

November 9, 2012

Doris Lefkowitz, Reports Clearance Officer
Agency for Healthcare Research and Quality
Dear Ms. Lefkowitz:
You have requested comments on AHRQ’s proposed information collection project: ‘‘A
Prototype Consumer Reporting System for Patient Safety Events, ’’ Federal Register /Vol. 77,
No. 175 /Monday, September 10, 2012 /Notices, No Docket No. Provided.) You describe the
proposed reporting system as having the goals of developing and designing a prototype system to
collect information about patient safety events; Web and telephone modes of a prototype
questionnaire; and protocols for a follow-up survey of health care providers.
The proposed method of collection includes a safety event intake form and follow up. The form
asks about a medical error or mistake, harm or injury as well as near misses, with voluntary
reporting by patients, family members and other caregivers through a Web site or by telephone.
You propose a range of questions: “what happened, details of the event, when, where, whether
there was harm, the type of harm, contributing factors, disclosure, and whether the patient
reported the event and to whom.” The willingness of reporters to answer follow-up questions by
CRSPS staff is also asked. This follow-up by phone will elicit further information and annotate
the report.
For consenting consumers, you will establish a cross check system, sharing the consumer reports
with patient safety officers at health care institutions that maintain adverse event reporting
systems. The purpose of this is to determine if the consumer report matches an event in the
provider’s Incident Reporting System, and if so, provide additional information. The data
collected will then be analyzed to produce descriptive statistics.
I am the Director of the Health Law Program at the Earle Mack School of Law at Drexel
University in Philadelphia. As part of teaching my Health Law I class this fall semester, my
students and I worked on the problem of adverse event detection. We have read widely in the
academic literature, have examined and discussed your proposal, and we offer some comments
on the concept and strategies you may consider in the implementation of your proposal.
First, we concur that a patient based adverse event reporting system has value as an additional
source of input on adverse events in health care institutions. We note that adverse event
reporting to date has not proved very effective, missing a very high percentage of predicted
adverse events. (Joel S. Weissman et al., Comparing Patient-Reported Hospital Adverse Events
with Medical Record Review: Do Patients Know Something That Hospitals Do Not? ANN.
INTER. MED. 2008;149:100-108, Table 4). Your proposed reporting system therefore has the

3320 Market Street • Suite 262 • Philadelphia PA 19104 215.571.4706 • fax 215.571.4712 • [email protected]

potential, if systematically implemented, to add further data points in the search for adverse
events, allowing a more accurate patient safety response aimed at reducing the rate of such
events. We note that the literature on adverse event detection finds that it requires multiple
strategies to get a full picture of the kind and level of such events in institutions. (See David W.
Bates et al., Policy and the Future of Adverse Event Detection Using Information Technology,
JAMA 10: 226, 226-27 (2003)).
We also note that there is considerable variation in adverse event definitions (see generally Barry
Furrow, Adverse Events and Patient Injury: Coupling Detection, Disclosure, and Compensation,
New Eng. L. Rev. 46: 437 (2012)). A common definition is “any injury caused by medical
care.”
(Glossary,
AHRQ
Patient
Safety
Network,
http://psnet.ahrq.gov/popup_glossary.aspx?name=adverseevent.) Distinctions between severe
and minor events need to be clearly delineated for purposes of data collection and the grouping
of patient harms. We conclude that the broadest possible definition, or scope of patient harms,
should be used to create a useful data set.
Tracking rates of adverse event changes is challenging. As Pronovost et al, note, “A prime
challenge in measuring safety is clarifying indicators that can be validly measured as rates. Most
safety parameters are difficult or impossible to capture in the form of valid rates for several
reasons: (1) events are uncommon (serious medication errors) or rare (wrong-site surgical
procedure); (2) few have standardized definitions; (3) surveillance systems generally rely on selfreporting; (4) denominators (the populations at risk) are largely unknown; and (5) the time period
for exposure (patient day or device day) is unspecified.” (Peter J. Pronovost, Marlene R. Miller&
Robert M. Wachter, Tracking Progress in Patient Safety JAMA 296: 696, 696 (2006)).
Researchers are increasingly developing triangulating systems using multiple modalities to
uncover adverse events. (Jennifer A. Taylor et al., Triangulating Case-Finding Tools for
Patient Safety Surveillance: A Cross-Sectional Case Study of Puncture/Laceration, INJURY
PREVENTION 17:388 (2011), available at
http://injuryprevention.bmj.com/content/17/6/388.full.pdf+html.) The use of patient surveys of
adverse events are likely to be a valuable addition, improving the calculation of rates of increase
and decrease of events over time.
Second, we believe that a broad scope of solicitation of patient responses about adverse events is
critical. Weismann et al concluded that adding adverse event questions to post discharge surveys
of patients was an effective way of discovering additional information.(Weismann, 2008). The
harder question is how to solicit such information in a multilayered opened way to maximize
data about adverse events, from the smallest harms to the most severe. Your proposed system
notes that “[t]he safety event intake form asks about a medical error or mistake, harm or injury as
well as near misses.” Your scope of questioning is broader than that used by Weisman et al.
They defined their patient sourced events as “serious and preventable adverse events” in their
study of the use of interviews of patients post discharge. Such a definition we believe is too
narrow: it will miss both less serious and so-called nonpreventable events. If “near misses” are
also defined with regard to such events, the possible universe of harms is too limited.
The idea that some patient harms are not preventable also makes an assumption about
avoidability that creates a blindspot in the reporting system: it may miss harms that can in fact be
prevented with the application of the right safety features. Focusing on avoidable medical errors
and mistakes tends to draw attention away from a system focus at mismanagement of risk in the
complex health care system. We note that your proposed intake form defines the scope of safety

events broadly, and we agree that the broadest possible solicitation of harms is preferable to
narrower definitions. We are less convinced that questions about “near misses” will be useful.
The AHRQ study should focus on those adverse events that have been or could be perceived by
patients in the course of or following their treatment. Focusing on “near misses” will likely prove
unsuccessful, as patients will, by definition, most likely be unaware that these events took place,
unless told so by a staff member.
Third, we propose consideration of a multi-layered survey approach. The reporting system
should be designed initially to elicit patient responses about their general experience in the
hospital, within at first drawing their attention too quickly to particular severe harms they might
have experienced. Follow-up surveys can look much more expansively at all adverse events,
broadly defined, in order to produce a larger data set. Such a system should solicit general
patient comments about satisfaction and hospital experience online or by telephone, without
mentioning adverse events at first. As patients mention specific events, questionnaires and
survey instruments should then pose more specific questions about harms a patient thinks he has
experienced.
Fourth, we urge consideration of strategies to maximize patient participation in the process of
submitted information, particularly online surveys. Incentives of various kinds might be
considered, such as gift cards upon completion, to promote more complete reporting. The merits
of a mobile application should also be evaluated. We note that while not all patients will have
access to a computer, a higher percentage are likely to have access to web-equipped cell phones
and other media devices. By developing a mobile app, researchers will be able to reach a broader
sample of health care consumers and allow a greater number to provide responses on adverse
events.
We further note that such reporting and survey tools are being applied to a large demographic of
very different patients. We suggest that researchers, if they choose to continue using the webbased survey model, should repeatedly verify its validity and reliability to ensure that the largest
number of people (of all different ages, educational levels, reading abilities and socioeconomic
statuses) are able to comprehend the questions and provide the information the researchers are
hoping to attain.
We hope that our comments will helpful to you as your proposal proceeds to implementation. If
you have any questions, please feel free to contact us, using my email and other contact
information.
Thank you.
Sincerely,
Barry R. Furrow
Sarah Bailey

Ryan Loftus

Chelsea Biemiller

Ashley Maguire

Elisa Boody

Trevor Serine

Krystyna Dereszowska

John Stringham

Tudor Farcas

Victoria Suarez

Victoria Han

Palmer Toto

Tim Koch

Alex Yohay

Garrett Lambur

Leah Zenou

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: A Prototype Consumer Reporting System for Patient Safety Events comments request
Friday, November 09, 2012 9:46:57 AM
FINAL Response to A Prototype Consumer Reporting System for Patient Safe....pdf

From: Darryl Roberts [mailto:[email protected]]
Sent: Wednesday, November 07, 2012 3:59 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: RE: A Prototype Consumer Reporting System for Patient Safety Events comments request

Dear Ms. Lefkowitz,
Please see the attached comment letter in response to the call for comments cited
above.
Regards,
Darryl W. Roberts, PhD, MS, RN
Senior Policy Fellow
Nursing Practice and Policy
American Nurses Association
8515 Georgia Ave. Suite 400
Silver Spring, MD 20910
301-628-5081 Phone
301-526-9555 Mobile
301-628-5343 Fax
[email protected]
www.nursingworld.org
Caring for Those Who Care

The contents of this message, together with any attachments, are intended only for the use of the
addressee and may contain legally privileged information that is exempt from disclosure. If you are
not the intended recipient, you are hereby notified that any dissemination, distribution or copying
of this message, or any attachment is prohibited. If you have received this message in error, please
contact the sender by return email and delete this message, along with attachments, from your
computer. Thank you.

November 9, 2012
Ms. Doris Lefkowitz
Reports Clearance Officer
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 2000
Rockville, MD 20850
Submitted electronically to: [email protected]
RE:
A Prototype Consumer Reporting System for Patient Safety Events, Published
September 10, 2012
Dear Ms. Lefkowitz:
The American Nurses Association (ANA), which is the only full-service professional organization
representing the interests of the nation’s 3.1 million registered nurses, appreciates the opportunity to
respond to the Agency for Healthcare Research and Quality (AHRQ) request for funding the pilot
project entitled, A Prototype Consumer Reporting System for Patient Safety Events. The project cites
three goals: 1) To develop and design a prototype system to collect information about patient safety
events; 2) To develop and test Web and telephone modes of a prototype questionnaire; and 3) To
develop and test protocols for a follow-up survey of health care providers.
This project appears to have the best intentions; however, for the reasons presented below the ANA
recommends that AHRQ complete additional improvement work prior to implementing a pilot
project. Further, the ANA recommends that AHRQ invest in improving patient use of existing
quality-related public reporting systems, such as Hospital Compare, Nursing Home Compare, and
Home Health Compare, as well as improving self-reporting systems, such as health care
organizations’ advocacy or ombudsman programs, and Medicare Quality Improvement
Organizations (QIOs), before engaging in pilots of new consumer reporting systems.
There are several effective methods in use for reporting patient safety events. For instance, many
hospitals and health care systems employ patient representatives or ombudsmen. Medicare
beneficiaries could report to QIOs. The AHRQ report does not mention the former and gives little
discussion to the latter, even though these services facilitate collection of consumer and patient safety
events and empower patients to present concerns and report events in a non-threatening and effective
manner. Individuals knowledgeable of these and other extant methods to capture and mitigate error
could provide AHRQ with valuable knowledge that could be used to improve and maximize the
effectiveness of these resources before AHRQ resorts to development and testing of new methods.
The ANA suggests that AHRQ review the challenge promoted by the Office of the National
Coordinator for Health Information Technology (ONC) to develop a handheld computer application
(app) for reporting patient safety events1. The ONC notice cites several important criteria required for
an app to win the challenge. Those criteria, while developed by another office within the Department
1

Challenge.gov. Reporting Patient Safety Events (http://challenge.gov/ONC/349-reporting-patient-safety-events).

2

of Health and Human Services and for a different purpose, are sufficiently broad and integral to the
success of any patient safety reporting system that AHRQ might benefit from including them in its
own project. In the text of the challenge document, the ONC states, “…it is important to innovate
beyond the existing tools so that a new system will:
1)
2)
3)
4)

Collect and analyze information that characterizes patient safety events in a standardized,
discrete, measurable way
Increase the rate of reporting of patient safety events and improve the quality of the reported
data
Leverage existing health information technology (HIT) to eliminate duplicate data entry, as
well as transcription and transposition errors
Analyze patient safety event data to provide useful reports and actionable information to
providers and PSOs”

As they currently read, neither the report nor the subsequent funding request sufficiently address or
clarify how the pilot system might meet those criteria.
Other issues could limit the effectiveness of a pilot. First, AHRQ mentions, but does not specify,
methods for patient engagement, data sharing, interoperability among systems, confidentiality of
data, or public reporting of results. Further, the report does not address the potential for high costs
associated with matching the reported error with the health care record. This matching could be
particularly challenging and costly in paper-based or disparate electronic systems. Additionally, the
report wisely recommends confidential data collection; however, the technical expert panel (TEP)
also recommends an option to report anonymously. The TEP does not clarify how anonymous
reports might contribute to error mitigation or reduction. Finally, AHRQ does not address
protections that might need to be placed to prevent negative repercussions to individual clinicians
named in any error reports.
In addition to overlooking the several existing methods of patient reporting, the report does not
acknowledge or address the role of legal remedies. The ANA certainly does not endorse legal
remedies for this purpose. However, ANA recognizes that many lawsuits arise from claims
regarding medical errors. These can involve claims of malpractice, personal injury, and product
liability contributing to personal injury or death. It could benefit AHRQ to acknowledge the
presence of legal remedies and determine methods to mitigate errors before victims resort to legal
remedies to effect changes. For example, AHRQ could investigate whether the proposed pilot would
increase, decrease, or have no effect on the frequency of legal remedies. Moreover, the report should
address how to protect the information collected by the system from improper usage in legal actions.
Most troubling is the fact that the survey questions or drafts of such questions are not included in the
report. In a recent New York Times interview2, Director Clancy gave some clues as to the content of
several questions. The article reports one draft question that directs respondents to, “Tell us the
name and address of the doctor, nurse or other health care provider involved in the mistake,”
indicating that this information and permission to share it with clinicians could improve safety. The
article lists a series of possible responses to answer why an event occurred. These include:

2

New System for Patients to Report Medical Mistakes (2012, September 22). New York Times.
(http://www.nytimes.com/2012/09/23/health/new-system-for-patients-to-report-medical-mistakes.html?_r=0).

3

•
•
•
•
•
•
•

“A doctor, nurse or other health care provider did not communicate well with the patient or
the patient’s family.”
“A health care provider didn’t respect the patient’s race, language or culture.”
“A health care provider didn’t seem to care about the patient.”
“A health care provider was too busy.”
“A health care provider didn’t spend enough time with the patient.”
“Health care providers failed to work together.”
“Health care providers were not aware of care received someplace else.”

Unfortunately, these types of subjective and judgmental statements could misdirect respondents away
from actually helping to solve the problem, but instead promote blaming an individual for the event.
Additionally, none of the questions or answers cited adds valuable information from the reported
incident that could inform a root cause analysis. Further, the questions and answers cited do not
reflect the systems approach to error prevention and remediation effectively promoted by such
organizations as The Institute of Medicine.
The ANA supports the idea of developing a method to improve consumer and patient access to an
effective and non-judgmental method of detecting, reporting, and mitigating health care errors. As a
profession, registered nurses are the most proximal and, therefore, most available clinicians
providing for the health care needs of patients and their families. Registered nurses strongly
advocate for the reduction of error and improvement of care structures, processes, and outcomes. In
this case, the ANA does not believe that the current project is ready for piloting until it addresses the
multiple issues cited above.
If we can be of further assistance, or if you have any questions or comments, please feel free to
contact Darryl Roberts, Senior Policy Fellow, National Center for Nursing Quality at
[email protected] or 301-628-5081.
Sincerely,

Marla J. Weston, PhD, RN, FAAN
Chief Executive Officer
American Nurses Association

cc: ANA President Karen A. Daley, PhD, MPH, RN, FAAN

From:
To:
Subject:
Date:
Attachments:
Importance:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Alert: New Task Assigned to Me and Others.
Friday, November 09, 2012 9:46:12 AM
Incoming 1460.pdf
High

Comment
From: Nunley, Cindy E. (AHRQ)
Sent: Wednesday, November 07, 2012 4:30 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Fatigati, Cathy (AHRQ)
Subject: FW: Alert: New Task Assigned to Me and Others.
Importance: High
Reminder....this was due today by 4:00. Please send your response to Cathy to close out the control.
Thanks.
From: Nunley, Cindy E. (AHRQ)
Sent: Tuesday, November 06, 2012 2:50 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Fatigati, Cathy (AHRQ)
Subject: FW: Alert: New Task Assigned to Me and Others.

Doris,
Here is the official control for the one Wendy has been asking about. It is due tomorrow, 11/7.
Thanks.
Cindy
From: [email protected] [mailto:[email protected]]
Sent: Tuesday, November 06, 2012 2:39 PM
Subject: Alert: New Task Assigned to Me and Others.

AHRQ CTS
2012-C-1460 - CCC Task - Response
Assigned on Nov 6, 2012 2:39 PM EST.
Priority: Normal

View this Task

This message has been sent automatically by AHRQ CTS.

KEITH D. WASHINGTON
6265 MAGNOLIA RIDGE
STONE MOUNTAIN, GA 30087
EMAIL: kd ••[email protected]

September 27, 2012
Ms. Carolyn M. Clancy, Director
Agency for Healthcare Research and Quality
Office of Communications and Knowledge Transfer
S40 Gaither Road, Suite 2000
Rno"""
"~"OSSA
__ ."- . . . le ,1YlJ..../...
v .
~~'-'

Re: Quality & Patient Safety
I was pleased to read that the administration of President Obama wants
consumers to report medical mistakes and/or unsafe practices by medical

personnel and hospitals.
Attached for your review is a letter concerning Piedmont Hospital, Atlanta,
Georgia, which I feel to be self-explanatory.
I feel strongly that as long as written permission must be obtained from the
treating physician and/or hospital executive's before specific infonnation
regarding possible mistakes or unsafe practices can become public they will
remain hidden and thus undennine your eflorts.
I would appreciate your thought's regarding this matter.

Sin~~~LuKeith D. wti~on
Attachment

_-

Quality Improvement
Organizatior.s

--- ..

FI,,_,L QL\LITY OF CARE

... - : -

D ETER~IDA TIOl\

TO THE BENEFICIARY

August 15, 20 I 2
Mr. Keith Washington
6265 Magnolia Ridge
Stone Mountain, GA 30087
Re:

...... ,") ,

~,-

Provider:

Pauline Washington
~ : :- .:: " : ! ~ 0 : .::~ ~ nl
Piedmont Hospital

·

Dear Mr. Washington;
Alliant I GMCF is the Quality Improvement Organization (Q IO) authorized by the Medicare
program to review medical services provided to Medicare patients in the state of Georgia. By
law, we review Medicare cases to determine if the services meet medically acceptable standards
of care, are medically necessary, and are delivered in the most appropriate setting. We are also
responsible for reviewing written complaints about quality of health care services received from
a Medicare beneficiary or their representative.
Our primary purpose is to identify areas where care can be improved and provide feedback
information to physicians and providers. In response to the ini tial written concern regarding your
care, our QIO physicians have reviewed the medical records concerning the services your mother
received on 03127/201 1 through 031281201 I at Piedmont Hospital.
Your concerns were:

•
•
•
•

A urine sample was not obtained until several hours after your mother was admitted to
tlte emergency rOOlll.
The emergency room nurse broke dowll crying claiming she was handling 8 patients
and hated to give poor care.
Failure to diagnose a Urinary Tract Infection in a timely manner.
Congestive Heart/ailure listed as the cause 0/ death on the Death Certificate.

In response to your request, actively practicing, board certified, Alliant I GMCF physician
consultants have reviewed your written complaints, the complete medical record, and
correspondence from your physician.

1455 Lincoln Pkwy I Suile 800 IAtlanta. GA 30346 / 800.982.0411 1Fax 678.527.3025 1www.gmC£org

ALLlANT I GMCF
~NG

HlAtTH CAU Urru.

As required by federal law, 42 CFR 480.105, Alliant I GMCF gave the involved practitioner the
opportunity to comment on our response concerning the healthcare services your mother was
provided before issuing this letter.

nFederal reglt/~14r.e. tIr.. AUien( ~ GMCE ~e-wriften permission from the
physician(s) in volved in the case under review before specific information about the care is
released. Th is applies whether our findings are positive or negative. In your case, such
consent was requested but not provided, so we are unable to give y ou specific information
about thefindings of our review. This does not mean that problems were identified; if
/!robkms:wer.e:i.de.nJ.ifled~ appropriate actions were taken. "
Thank you for taking the time and effort to voice your concerns. Your desire to prevent this
situati on fo r ot hers is admirable. We be!ie,-e \1ed:c2!""e cene5 ci a:: es and :heir r'a.·'Tl.:lies. hdp:.:improve the health care systems by openly and honestly sharing their concerns. as yo.: :::.
If you need further information or clarification, please contact Deirdre Davis, Medicare Review
Nurse Consultant at 1·800·982-0411 option 2.

,
Sincerely,

(d, UVV/1'~.\!.-V'"'vVV~

Adrienne D. Mims, M.D. MPH
Medi cal Director
Georgia Medical Care Foundation
Quality Improvement Organization

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: AHRQ pilot study
Friday, November 09, 2012 9:45:00 AM
Regarding the NY Times article.docx

-----Original Message----From: Lisa Hess [mailto:[email protected]]
Sent: Thursday, November 08, 2012 9:56 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: AHRQ pilot study
Dear Dr.Lefkowitz,
Thank-you very much for replying to my email regarding the AHRQ pilot study. I have attached a
document with some alternative wording to the questions that the study presents in section 5 of the
patient medical error reporting questionnaire. I appreciate you taking the time to review this document.
Sincerely,
Lisa Hess, MD
[email protected]
255 North St
Iowa City, Ia 52246

Regarding the NY Times article: Pear, R. (2012,Sept.22) “New System for Patients to
Report Medical Mistakes”.
As a practicing OB/Gyn. in Iowa, I am very interested in patient safety. Healthcare
suffers from poor communication between patients and their providers, and the proposed
survey tool could help. However, the language used to describe reasons for errors is
adversarial at best and will serve only to exacerbate the problem. For example, the
questionnaire offers: “A health care provider was too busy” as a possible cause of a
medical error. The simple adjective “too” unnecessarily implies personal fault. Why not
ask “Did you have enough time with your provider”? The way these “possible reasons
for medical errors” are stated in the questionnaire continues the tradition of creating
blame and shame when an error occurs, contributing to poor reporting of medical errors
by healthcare providers. By removing the blame and emotional triggers in this
questionnaire, the information received will be far more useful and effective.
Lisa Hess, MD
255 North St
Iowa City, Ia, 52246
[email protected]
(319) 360-1725

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Proposed Information Collection - Consumer Reporting System for Patient Safety Events
Thursday, November 08, 2012 8:37:02 PM
AHRQ-reporting-OMBW.pdf

comments

From: Gavin Baker [[email protected]]
Sent: Thursday, November 08, 2012 5:29 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Proposed Information Collection - Consumer Reporting System for Patient Safety Events

Ms. Lefkowitz,
Please see attached the comments of OMB Watch on the Agency for Healthcare Research and
Quality’s proposed information collection for a consumer reporting system for patient safety
events.
Sincerely,
Gavin Baker
Federal Information Policy Analyst
OMB Watch
[email protected]
Phone: (202) 683-4834
Twitter: @opengavin
LinkedIn: gavinrbaker

Combined Federal Campaign #10201

November 9, 2012
Ms. Doris Lefkowitz
Reports Clearance Officer
Agency for Healthcare Research and Quality
via email to [email protected]
Re:

Agency Information Collection Activities: Proposed Collection; Comment Request
(77 FR 55475)

Dear Ms. Lefkowitz:
OMB Watch welcomes the opportunity to comment on the Agency for Healthcare Research and
Quality’s (AHRQ) proposed information collection. As a nonprofit organization dedicated to
open government, accountability, and citizen participation since 1983, OMB Watch has long
worked for effective government information collection practices and ready access to consumer
information.
OMB Watch shares AHRQ’s concern with improving patient safety and agrees that a consumer
reporting system could “realize untapped potential of health care consumers to provide important
information about patient safety events.”1 OMB Watch supports the development of a prototype
system and encourages AHRQ to apply the lessons learned from the proposed information
collection, if approved, toward the development of a national reporting system.
OMB Watch offers the following comments on the proposed information collection:
1. The proposed information collection will inform consumers and improve patient safety;
and
2. Information sharing would enhance the utility of the proposed information collection.
1. The Proposed Information Collection Would Inform Consumers and Improve
Patient Safety
OMB Watch believes that the proposed information collection would have practical utility in
advancing AHRQ’s health care research and information dissemination functions. OMB Watch
agrees that “data about the consumer-reported patient safety events will be useful to the health
care providers … in quality or performance improvement.”2 Therefore, OMB Watch encourages
AHRQ to collect, analyze, and share the data with the health care providers.
1
2

Notice.
Supporting Statement A, p. 5.

Page 1 of 3

In addition, OMB Watch believes that even greater utility could be realized through additional
uses of the data. Sharing the data with researchers, regulators, and the public would help to
inform consumers and improve patient safety, as we explain below.
2. Information Sharing Would Enhance the Utility of the Proposed Information
Collection
AHRQ should develop a plan to share the information proposed for collection. The agency’s
supporting statement addresses the confidentiality of the information3 but does not address the
issues of information sharing or public access. We agree that the consumer reports will be
“highly valuable, even if not fully generalizable.”4 Therefore, we encourage AHRQ to explore
ways to share the data with researchers, regulators, and the public.
Researchers: AHRQ should allow researchers outside the project team to analyze the data.
Sharing the data with external researchers would enhance the utility of the information collected
by facilitating more extensive research and additional analytic approaches. Researchers could
then share their findings with health care providers, policymakers, and other researchers, who
could apply the findings to improve patient safety. Researchers could also publicly report their
findings, which would inform consumers about patient safety risks and trends. To protect
confidentiality, AHRQ could provide full access only to qualified researchers who agree to keep
the data secure, under a similar approach as the Qualified Entity Program conducted through the
Centers for Medicare & Medicaid Services.
Regulators: AHRQ should share reports with relevant regulatory and law enforcement
authorities at the federal, state, and local levels when a consumer reports a possible violation of
law or regulation. Sharing reports with regulators could enhance enforcement, which could
ultimately strengthen patient safety.
Public: AHRQ should explore ways to provide public access to the data. Consumer reporting
databases can be valuable tools for the public, as demonstrated by other agencies already
experienced in them. The National Highway Traffic Safety Administration (NHTSA), the
Consumer Product Safety Commission (CPSC), and the Consumer Financial Protection Bureau
(CFPB) have made non-confidential extracts of consumer reports accessible online in order to
help the public make informed decisions. Disclosing consumer-reported data allows other
consumers and their advocates to identify trends, avoid harmful products and services, and
address problematic patterns. AHRQ should examine the feasibility of publicly disclosing nonconfidential information about individual reports, as well as aggregate data.
3
4

Supporting Statement A, p. 6-7.
Supporting Statement A, p. 6.

Page 2 of 3

AHRQ should consider the benefits of sharing the information collected, particularly if the
prototype expands into a national system.
Conclusion
OMB Watch appreciates the opportunity to comment on AHRQ’s proposed information
collection. We hope you take our recommendations into consideration. If you have questions
about our comments or want to discuss the issues further, please feel free to contact us.
Sincerely,

Sean Moulton

Gavin R. Baker

Director, Federal Information Policy

Federal Information Policy Analyst

OMB Watch

OMB Watch

Page 3 of 3

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: GNYHA Comments on the Consumer Reporting System for Patient Safety
Thursday, November 08, 2012 1:11:23 PM
GNYHA Comments_CRSPS_lr eec.docx

From: Ryan, Lorraine [mailto:[email protected]]
Sent: Thursday, November 08, 2012 1:08 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Donohue, Kelly
Subject: GNYHA Comments on the Consumer Reporting System for Patient Safety

Dear Dr. Lefkowitz:
Attached please find GNYHA’s comments on the proposed Consumer Reporting System for
Patient Safety. Please feel free to contact me with any questions you may have.
In addition to these comments, I did have a question as to the eligibility and selection process for
hospitals to participate in the analysis and research on the data derived from the reporting system.
Thank you.

Lorraine
Lorraine Ryan
Senior Vice President
Legal, Regulatory and Professional Affairs
Greater New York Hospital Association
555 West 57th Street
New York, NY 10019
Phone: 212-506-5416
Fax: 212-262-6350
E-mail: [email protected]

November
Eight
2012
Doris Lefkowitz, Ph.D.
Reports Clearance Officer
AHRQ
540 Gaither Road, Room #5036
Rockville, Maryland 20850
RE: Comments on the Consumer Reporting System for Patient Safety
Dear Dr. Lefkowitz:
Greater New York Hospital Association (GNYHA) appreciates the opportunity to provide
comments on the proposed Consumer Reporting System for Patient Safety. GNYHA represents
approximately 250 hospitals and continuing care facilities in the New York metropolitan area, as
well as throughout New York State, New Jersey, Connecticut, and Rhode Island. All of
GNYHA’s members are either not-for-profit, charitable organizations or publicly sponsored
institutions.
GNYHA Focus on Patient Safety
GNYHA is a membership-driven organization, and in this regard, GNYHA has devoted and will
continue to devote considerable resources to assisting our members with improving quality,
patient safety, and efficiency through innovation, education, and collaboration among members,
as well as with regulatory, accrediting, and professional bodies. In the past several years, these
collaborations have led to decreased C. difficile infection rates, infection rates associated with
central lines, better identification of sever sepsis and septic shock, and increased awareness of
proper use of antibiotics among participating members. Most recently, GNYHA has partnered
with the Healthcare Association of New York State (HANYS) to serve as a Hospital Engagement
Network under the Partnership for Patients, a national initiative of the Centers for Medicare &
Medicaid Services to advance its goals of better health, better care, and lower costs.
Additionally, GNYHA has a long history of promoting transparency and public reporting to
achieve better outcomes of care.
Incident Reporting in New York State
Since the 1980’s, New York State had mandated that certain types of patient, staff, and
environmental events by hospitals and licensed diagnostic and treatment centers be reported. The
overall goal of incident reporting requirements is to improve the delivery of health care for all
New Yorkers. Initially the focus of the incident reporting requirements was on accountability,
but the focus has expanded and evolved into the New York Patient Occurrence Reporting and
Tracking System (NYPORTS), a program that focuses on accountability, as well as quality
improvement. GNYHA has been a part of an advisory body to the incident reporting program,

the NYPORTS Council, since its inception in 1999. GNYHA has also worked with the New
York State Department of Health (DOH) for the last several years to refine and improve
NYPORTS to ensure that it is an effective reporting system. The most recent revisions to
NYPORTS were made in 2011 with the goal of promoting more complete reporting for the most
serious types of cases.
Proposed Consumer Reporting System for Patient Safety
GNYHA supports the concept of collecting patient and family caregiver information about health
care safety events to enhance the quality, appropriateness, and effectiveness of health services.
The reporting system AHRQ proposes aims to collect information from patients and family
members about medical errors that resulted, or nearly resulted, in harm or injury, known as “near
misses,” that are not currently collected by health care providers. Although GNYHA supports
this concept, we have a number of concerns which are articulated below.
GNYHA and its members are concerned about the validity and reliability of the reports that
will be entered into the proposed Consumer Reporting System for Patient Safety (CRSPS).
As outlined in the CRSPS Supporting Statement documents, it is not clear how the program’s
evaluators will distinguish between perceived lapses in care and actual medical errors and other
health care safety events. GNYHA is concerned that patients and families may not be able to
reliably distinguish a clinical complication or outcome of care that is not preventable from a
preventable complication or medical error. The failure to screen out what may not be valid
complaints or observations will negatively affect the integrity of the CRSPS program.
GNYHA believes there should be a mechanism for consistent and reliable health care provider
follow-up on the reports consumers submit.
According to the Supporting Statement documents, CRSPS feedback to hospitals about
complaints or reports that have been made about the hospital or other provider will only be made
if the reporting patient or family member consents to that feedback being given to the provider.
This will result in a body of data that is fragmented and incomplete. It will not meet the intended
purpose of the CRSPS noted in the Supporting Statement as follows, “…such information is
necessary for research on how to improve the quality of care, promote patient safety and reduce
medical errors. There is a need to collect this information from consumers and match these
consumer reports to the information collected by providers, because the two sources may differ.
Examining data from both sources allows the project to determine to what extent patients are
able to provide more complete or more detailed information.” To meet this intent, reports must
be shared with health care providers consistently and in all cases.
GNYHA and its members are concerned about the unwarranted and unintended increase in
malpractice liability exposure that could result from the CRSPS.
The CRSPS has the potential to exacerbate and increase medical malpractice costs. The current
medical malpractice system in this country is already fraught with invalid, baseless claims that
result in unnecessary expense. In fact, studies indicate that 40% of medical malpractice claims
involve no error, yet 28% of such no-error claims result in payments. GNYHA believes that the
inability of consumers to distinguish preventable error from unavoidable complications of care
secondary to patient co-morbidities will result in additional unwarranted and costly litigation.
In conclusion, GNYHA believes that the proposed CRSPS may provide valuable information to
enhance quality and patient safety and identify effective methods of engaging consumers in
reporting health-related safety events. However, the CRSPS must be constructed carefully, with
-2-

structured definitions of what should be reported, appropriate feedback mechanisms enabling
providers to use consumers’ information and observations to effectively improve systems and
processes of care, and provider protections from unfounded and baseless complaints of adverse
events.
GNYHA thanks AHRQ for inviting comments on the proposed CRSPS, and is available to
provide additional feedback on the proposed system.
Please feel free to contact me with any questions you may have about these comments.
Very truly yours,

Lorraine Ryan
Senior Vice President, Legal,
Regulatory, and Professional Affairs
GNYHA
(212) 506-5416
[email protected]

-3-

From:
To:
Subject:
Date:
Attachments:
Importance:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Amerigroup Comments on "A Prototype Consumer Reporting System for Patient Safety Events"
Thursday, November 08, 2012 12:36:49 PM
Amerigroup Comments on AHRQ Consumer Reporting System _2012-11-8__FIN3.pdf
High

comments
From: Gordon, Stuart [mailto:[email protected]]
Sent: Thursday, November 08, 2012 9:52 AM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Oddo, Angel; Winiarek, Claire; Friedman, Merrill; Coyne, Brian
Subject: Amerigroup Comments on "A Prototype Consumer Reporting System for Patient Safety Events"
Importance: High

Ms. Lefkowitz –
Amerigroup thanks you for the opportunity to offer comments on the development of a Consumer
Reporting System for Patient Safety (CRSPS) and on the proposed collection of consumer
experiences. As a leader in coordinating and managing health care services and supports for the
financially vulnerable, seniors and people with disabilities, we appreciate the Agency for
Healthcare Research and Quality’s (AHRQ’s) work to advance this important issue and to do so with
stakeholder and consumer engagement.
In our attached comments, we support the AHRQ’s development and testing of a reporting system
that captures consumers’ experience with medical errors or mistakes. We believe the agency’s
development of a prototype CRSPS represents a strong first step in developing a practical
framework for measuring and reporting on preventable occurrences. The prototype CRSPS, under
development, will ensure the collection and availability of usable information for assessing the
scope and scale of health care safety events in line with today’s standards. We are supportive of
the establishment of an effective monitoring and reporting system, and believe the prototype will
have practical utility beyond the agency’s own initiative; information collection can and should be
shared publicly in support of related research, the development of evidence-based best practices
and in assessing the efficacy of patient safety activities.
However, we are concerned the collection notice, as proposed, does not reflect a comprehensive
use of new technologies, which may inhibit the quality, utility and clarity of the information to be
collected. We also believe the employment of new technologies may minimize the time burden of
the collection of information upon both consumer and provider respondents. Specifically, we
recommend the final information collection use a smartphone and Internet or email-based
approach, particularly for respondents serving low-income populations and who are themselves
beneficiaries of an insurance affordability program.
Amerigroup has made significant investments in determining how best to connect with our lowincome members and to solicit their input on issues relating to their health care services and care
management. In recent years, due to the quantitatively demonstrated significance of smartphone

devices and the Internet in the day-to-day lives of financially vulnerable populations, we have
advanced text messaging and social media campaigns to solicit a more engaged respondent base.
Our smartphone-based information gathering campaigns have sometimes achieved response rates
as high as 40 to 50 percent.
In our comments, we suggest that the AHRQ could determine the extent to which it should utilize
these approaches by first asking respondents if they would be willing to provide their smartphone
numbers or email addresses for purposes of sharing their experience with medical errors or
mistakes. Those respondents affirmatively responding would be included in this approach to the
survey. While we recognize there could be some concerns about the security and validity of
responses electronically transmitted, the risks of disclosure and false results are likely to be no
greater than would exist with the use of telephone surveys. We also note that these technologies
can help create a streamlined, facile, accessible and less burdensome survey, likely to result in a
more robust response.
If you have any questions or would like to discuss our comments further, please feel free to contact
Angel Oddo, Amerigroup’s Senior Vice President for Quality Management, at 757-769-7852 or by
email to [email protected] .
Again, thank you for the opportunity to offer our thoughts.

Stuart Yael Gordon
Director, Government Relations
Amerigroup
750 1st Street NE
Suite 1120
Washington, DC
phone: 202-218-4925
fax: 202-682-0786
cell: 202-213-4702
[email protected]
www.amerigroup.com

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Nov. 8, 2012
Doris Lefkowitz
Reports Clearance Officer
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
540 Gaither Rd.
Rockville, MD 20850
Submitted by email to [email protected]
Re:

Agency Information Collection Activities: Proposed Information Collection; Prototype
Consumer Reporting System for Patient Safety Events

Dear Ms. Lefkowitz:
On behalf of Amerigroup, we thank you for the opportunity to offer comments on the development of a
Consumer Reporting System for Patient Safety (CRSPS) and on the proposed collection of consumer
experiences. As a leader in coordinating and managing health care services and supports for the
financially vulnerable, seniors and people with disabilities, we appreciate the Agency for Healthcare
Research and Quality’s (AHRQ’s) work to advance this important issue and to do so with stakeholder and
consumer engagement.
Amerigroup and our affiliated health plans coordinate health care services for approximately 2.7 million
members in publicly funded health care programs, including Medicaid and the Children’s Health
Insurance Program, in 13 states across the country and in Medicare Advantage in eight states.1 We are
scheduled to begin offering Medicaid managed care services in the state of Kansas, our 14th state, in
January 2013.
Let me first share that we support the AHRQ’s development and testing of a reporting system that
captures consumers’ experience with medical errors or mistakes. We believe the agency’s development
of a prototype CRSPS represents a strong first step in developing a practical framework for measuring
and reporting on these preventable occurrences. Amerigroup supports the creation of prevention and
safety cultures that improve the delivery of health care and patient health outcomes by doing the
following:
•
•

Developing tools and providing education to support providers, stakeholders and consumers in
their patient safety activities
Establishing effective monitoring and reporting systems to identify patient safety issues in a
timely manner
1. Membership as of June 30, 2012.

4425 Corporation Lane
Virginia Beach, VA 23462
757-490-6900
www.amerigroup.com

•
•

Improving communication, linkages, transparency and information sharing to foster a
prevention and safety culture
Using evidence-based prevention and safety activities and the dissemination of best practices,
to include a focus on national initiatives

The prototype CRSPS, under development, will ensure the collection and availability of usable
information for assessing the scope and scale of health care safety events in line with today’s standards.
We are supportive of the establishment of an effective monitoring and reporting system, and believe
the prototype will have practical utility beyond the agency’s own initiative; information collection can
and should be shared publicly in support of related research, the development of evidence-based best
practices and in assessing the efficacy of patient safety activities.
However, we are concerned the collection notice, as proposed, does not reflect a comprehensive use of
new technologies, which may inhibit the quality, utility and clarity of the information to be collected. We
also believe the employment of new technologies may minimize the time burden of the collection of
information upon both consumer and provider respondents. Specifically, we recommend the final
information collection use a smartphone and Internet or email-based approach, particularly for
respondents serving low-income populations and who are themselves beneficiaries of an insurance
affordability program.
Amerigroup has made significant investments in determining how best to connect with our low-income
members and to solicit their input on issues relating to their health care services and care management.
In recent years, due to the quantitatively demonstrated significance of smartphone devices and the
Internet in the day-to-day lives of financially vulnerable populations, we have advanced text messaging
and social media campaigns to solicit a more engaged respondent base. Our smartphone-based
information gathering campaigns have sometimes achieved response rates as high as 40 to 50 percent.
The AHRQ could determine the extent to which it should utilize these approaches by first asking
respondents if they would be willing to provide their smartphone numbers or email addresses for
purposes of sharing their experience with medical errors or mistakes. Those respondents affirmatively
responding would be included in this approach to the survey. While we recognize there could be some
concerns about the security and validity of responses electronically transmitted, the risks of disclosure
and false results are likely to be no greater than would exist with the use of telephone surveys. We also
note that these technologies can help create a streamlined, facile, accessible and less burdensome
survey, likely to result in a more robust response.
Amerigroup commends the agency for its efforts to advance consumer reporting systems development
transparently with robust stakeholder and consumer engagement. If you have any questions or would
like to discuss our comments further, please feel free to contact me at 757-769-7852 or by email to
[email protected].
Sincerely,

Angel Oddo
Senior Vice President, Quality Management
Amerigroup Corporation
Amerigroup Corporation Letter Re: Agency Information Collection Activities: Proposed Information Collection;
Prototype Consumer Reporting System for Patient Safety Events

Page 2

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comments on the proposed information collection project
Tuesday, November 06, 2012 8:54:02 AM

File with comments
-----Original Message----From: [email protected] [mailto:[email protected]]
Sent: Monday, November 05, 2012 9:45 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comments on the proposed information collection project
Dear Ms. Lefkowitz,
I am writing in strong support of the proposed information collection project, "A Prototype Consumer
Reporting System for Patient Safety Events."
As the daughter of a disabled elderly who was killed by a preventable medication error, I appreciate the
concept to incorporate patients’ experiences and perspective into the evaluation of quality of care. Time
after time, it has shown that many healthcare providers and hospitals are not honest about medical
errors and fail to report them. As documented in a recent report by the Office of the Inspector General,
only 1% of adverse events are actually reported by hospitals.
If we want to improve the quality of medical care and patient safety, this problem of under reporting by
medical professionals must be changed.
In this modern world with tons of medical information available, patients are getting smarter and are
more informed than ever. They have a very good sense of what happens in their care and to their
bodies, and what is right and what is wrong. In an article published by Zhu et al. in 2011, it shows that
over 70% of adverse events reported by patients are accurate. However, many doctors and hospitals,
even including state medical boards tend to discount patients’ reports. Often, they label the patients
who complain as being trouble makers. This kind of attitude by the healthcare providers and hospitals
are self-serving, to say the least.
So, I am so glad to see AHRQ is taking this important step in the right direction because it is long
overdue to listen to patients about the quality of their own care. Furthermore, the patients’ reports will
provide additional information on patient safety, invaluable for improving medical quality. As a volunteer
patient safety advocate, I would be happy to help test out the proposed patient reporting system.
The following are some detailed suggestions to the proposed “CRSPS Intake Reporting Form”:
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
1. In SECTION 3: MISTAKE: “3.1 Did the medical mistake or error involve any of the following? D. A
mistake related to a diagnosis, or treatment, or advice from a doctor, nurse, or other healthcare
providers”:
***** I recommend adding the word “treatment” in category D.
2.

Under 3.1.1 related to medication:

***** I recommend adding two questions that relate to medication:
“Was the prescribed medication used off label?”
“Was the prescribed medication contraindicative to any medical conditions?”
3.

Under 4.2.1. “What kind of physical negative effect did the patient experience?”

***** I recommend adding several more categories here:
(a) Worsened existing medical conditions;
(b) heart failure;
(c) respiratory failure;
(d) kidney failure;
(e) bedsores;
(f) permanent damage;
(g) disabled;
(h) death
4. Under SECTION 5: “CONTRIBUTING FACTORS, CHANGES IN CARE,
DISCOVERY, & REPORTING 5.1. Why do you think this mistake or negative effect happened?”
***** I recommend adding a category related to the competency of health care providers.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Please let me know if you have any questions regarding my comments. Thank you for your assistance.
Best Regards,
Yanling Yu
3941 NE 158th lane
Seattle, WA 98155
[email protected]
206-366-1629

_________________________________________
Yanling Yu, PH. D
University of Washington
616 NE Northlake Place
Seattle, WA 98105
Phone: 206-543-1254

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: patient reports on medical errors
Monday, November 05, 2012 8:53:40 AM

comments
From: [email protected] [mailto:[email protected]]
Sent: Friday, November 02, 2012 5:55 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: patient reports on medical errors
Excellent idea. Should be simple, short, and not be connected or implied to be connected with potential
lawsuits. A simple form given at discharge with option of gong to a website (save postage). Last
question: what do you think could havae been, if anything, to prevent the problem that you had?
Stress that not designed to get physicians or other staff into trouble, but to improve patient care.
Perhaps outpatients should be included also.
Shirley Linde
MedicalInformationCenter.org
ShirleyLinde.com

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: RESPONSE TO FEDERAL REGISTER NOTICE # 2012-22028
Friday, November 02, 2012 8:40:36 AM
Carolyn Clancy Letter Nov 2012draft (2).pdf

File with comments
From: Mike Cohen [mailto:[email protected]]
Sent: Thursday, November 01, 2012 4:14 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: RESPONSE TO FEDERAL REGISTER NOTICE # 2012-22028

Please accept this response to Federal Register Notice # 2012-22028, regarding the
proposed project, A Prototype Consumer Reporting System for Patient Safety Events.
Thank you.
Michael R. Cohen

ISMP is a federally certified patient safety organization (PSO).
Visit our consumer website and sign up for customized medication safety alerts:
http://www.consumermedsafety.org
CONFIDENTIALITY NOTICE:This e-mail message, including any attachments, is for the sole use of
the intended recipient(s) and may contain confidential and privileged information. Any
unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended
recipient, please contact the sender by reply e-mail and destroy all copies of the original message.

Mike Cohen
Institute for Safe Medication Practices
200 Lakeside Drive, Suite 200
Horsham, PA 19044
e-mail: [email protected]
web: www.ismp.org
tel: 215 947 7797
fax: 215 914 1492

November 1, 2012 

Carolyn Clancy, MD 
Director 
Agency for Healthcare Research and Quality 

In care of: Doris Lefkowitz,  
Reports Clearance Officer, AHRQ  
[email protected]. 

RESPONSE TO FEDERAL REGISTER NOTICE # 2012‐22028 

Dear Dr. Clancy: 

The Institute for Safe Medication Practices (ISMP) would like to comment on the September 10, 2012, Federal 
Register notice regarding the development of a prototype consumer reporting system for patient safety (CRSPS). 
ISMP has three primary concerns that we feel should be addressed before moving forward—the program’s 
apparent punitive focus as it relates to collection of reports, lack of a plan to use the reports for learning and 
safety improvements, and a failure to coordinate efforts with existing consumer reporting programs.   

Comments on CRSPS 

Issue #1: Punitive focus. The CRSPS plan suggests that consumers will be asked to identify individual healthcare 
providers involved in the reported events and that these healthcare providers will be contacted to provide 
additional information about these events. ISMP has several concerns with this reporting format. First, it 
perpetuates a punitive culture of finger‐pointing and suggests to the consumer that action will be taken against 
individuals involved in the errors, particularly given that the current CRSPS plan does not describe any other 
actions that may result from the reporting program, such as learning about the system‐based causes of errors and 
recommending strategies that may reduce the risk of errors (see Issue #2). In its current state, the reporting 
program appears to be a  mechanism for consumers to report healthcare providers who have made errors, with a 
promise to consumers to put the healthcare providers on notice about their unacceptable lack of perfect 
performance. The current format also conveys the misconception that individuals are wholly responsible for 
errors, disregarding the influences of system design and the environment that play a large role in human error 
and behavioral choices. In addition, healthcare providers who are contacted after a consumer has reported an 
error will naturally be defensive about the event. It would not be a far reach to assume that these individuals will 
feel as though they and their organizations have been “reported” to the government and are now being 
summoned to defend themselves. The usefulness of the information from healthcare providers will likely be 
compromised by defensive posturing rather than cooperation to uncover behavioral choices and system design 
issues that contributed to the error.  

Issue #2: Use of reports to improve safety. The CRSPS plan presented in the Federal Register says the 
demonstration project will “record data from consumers,” but does not take the next crucial step and indicate 
how the reports received will be evaluated, analyzed, shared with a broader audience, and used in any way to 
enhance learning or improve safety. As is, the plan calls only for reporting without sufficient planning of expert 
analysis of the data, dissemination of lessons learned, and use of the information to improve safety. Our common 

ISMP RESPONSE TO FEDERAL REGISTER NOTICE # 2012‐22028 
November 1, 2012 
Page 2 

goal in terms of patient safety should be to provide healthcare professionals, the medical products industry and 
the general public with realistic prevention strategies to help stop mistakes and adverse events from occurring. If 
CRSPS collects new data, but it is never reviewed by experts who can pass on new insights about safety risks, then 
the reporting program ultimately will have no impact on error prevention. Again, its only perceived purpose may 
be to report “bad” healthcare providers who have made an error.   

Collaboration with other existing programs. The CRSPS plan also does not mention any collaboration with other 
federal agencies or patient safety organizations to ensure that data will be consolidated with other existing 
consumer reporting programs. For example, ISMP currently has an agreement with another federal agency—The 
US Food and Drug Administration (FDA)—to share safety information and material on our respective consumer 
websites. In addition, ISMP and FDA have established an open line of communication regarding our respective 
analysis of the data provided by our respective consumer reporting programs, which has resulted in a powerful 
alliance when crucial drug safety information and recommendations need to be communicated to the healthcare 
community and consumers at large. This kind of collaboration best serves patients by making sure that a common, 
accessible body of knowledge is formed and used to its fullest capabilities to guide improvements. 

Background on ISMP consumer reporting program. ISMP was founded decades ago to uncover more about 
medication errors happening across the nation, understand their causes, advocate for safe practices and share 
“lessons learned.” The Institute has had extensive experience with error reporting, including operating a non‐
governmental national voluntary medication error‐reporting program for healthcare professionals. Since 2008, 
ISMP has operated an active consumer medication error‐reporting program on its consumer website at 
http://www.consumermedsafety.org and also accepts telephone calls from consumers. A registered nurse is 
employed to handle the website and consumer telephone calls. The ISMP reporting program for consumers is 
accessed at: http://www.consumermedsafety.org/report‐a‐medication‐error. ISMP has shared safety 
recommendations based on consumer reports with the entire healthcare community through its newsletters and 
websites and journal columns. The Institute also educates the healthcare community weekly or more often 
through its “Check‐up” blog on Philly.com (http://www.philly.com/philly/health/97905324.html), the Philadelphia 
Inquirer’s website, as well as in the newspaper itself when appropriate. The Institute provides all of these services 
at no cost to the American taxpayer.  

FDA also operates an active consumer section of the FDA.gov website and a reporting program for consumers. 
The Agency has formally partnered with ISMP to share reports of medication errors and promote safety 
improvements (http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM297672.pdf). Consumer 
reports to ISMP have sometimes resulted in FDA public health advisories or other actions.   

We hope that AHRQ will dedicate additional time and resources to evaluation, safety advocacy for needed 
changes, and communication of data gained through CRSPS, so that it will ultimately have an impact and provide a 
benefit in safeguarding healthcare consumers. 

Sincerely, 

Michael R. Cohen, RPh, MS, ScD (hon), DPS (hon) 
President 

MRC/ls

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: AHRQ Comment on Proposed Program via the Rand Corporation to monitor "doctor errors"
Thursday, November 01, 2012 1:37:53 PM

comments
From: Bert Cobb [mailto:[email protected]]
Sent: Thursday, November 01, 2012 12:04 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: AHRQ Comment on Proposed Program via the Rand Corporation to monitor "doctor errors"
Dear AHRQ (Ms. Doris Lefkowitz, Reports Clearance Officer),
With the limited resources for providing health care and the number of doctors leaving medicine
because of bureaucracy, how will this "program" in any way alleviate the shortages? My fellow doctors
find this demeaning and a further barrier between patients and providers. It ASSUMES errors WILL BE
COMMITTED a priori when the FACTS are otherwise. Government intrusion into medicine is KILLING
the practice of medicine and the strong bond of patients with THEIR doctors. This is but another
example of more paperwork that will not enhance the quality of health care. The attorneys will LOVE
for you to identify potential lawsuits FOR THEM. In Texas, we work under the aegis of The Texas
State Board of Medical Examiners. They are the most demanding and stringent "masters" one could
imagine. We are held to the highest standards of practice and behavior with oversight from medical
and lay board members who LOVE to punish physicians. Now you want to do the same NATIONALLY
and MAKE us comply? Are you nuts are merely misguided? Trash the idea and let Rand Corporation
do something realistic and that will IMPROVE medical care and ADD to the number of providers. Stay
out of medicine because you know NOTHING of its rigors, requirements and dedication. This is
INSULTING. For a change, why don't you ASK YOUR DOCTOR how he or she feels about your
"program"? Ask quickly because this program may be the straw that breaks the camel's back and they
QUIT.
Sincerely yours,
Bert Cobb, M.D.
P.O. Box
San Marcos, Texas 78667-0913

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: AOA letter concerning CRSPS prototype
Wednesday, October 31, 2012 2:07:14 PM
AOA AHRQ Prototype comments 103112.pdf

From: Monaco, Carol [mailto:[email protected]]
Sent: Wednesday, October 31, 2012 1:36 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: AOA letter concerning CRSPS prototype

Hello Ms. Lefkowitz,
The AOA is submitting comments on AHRQ’s Prototype Consumer Reporting System
for Patient Safety Events. Please see the attachment. Thank you.

Carol Monaco
Director of Federal Affairs
AMERICAN OSTEOPATHIC ASSOCIATION
1090 Vermont Ave. NW
Suite 500
Washington, D.C. 20005
Toll Free: (800) 962-9008 ext. 8645
Phone: (202) 414-0145
Fax: (202) 544-3525
www.osteopathic.org

AOA: TREATING OUR FAMILY AND YOURS

October 31, 2012
Carolyn Clancy, M.D., Director
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Submitted electronically via: [email protected]
Re: AHRQ Prototype Consumer Reporting System for Patient Safety
Events
Dear Dr. Clancy,
The American Osteopathic Association (AOA), which represents more than 100,000 osteopathic
physicians and medical students, appreciates the opportunity to comment on the Agency for
Healthcare Research and Quality’s (AHRQ) proposed Consumer Reporting System for Patient
Safety Events (CRSPS). The AOA commends AHRQ for its efforts to design and test a system for
collecting information from patients about health care safety events following standard definitions
and formats. There is no doubt that patients provide a unique and valuable perspective on health
care and that patient reports could complement and enhance provider input and thus produce a
more complete and accurate understanding of the prevalence and characteristics of medical errors.
While we appreciate the agency’s efforts to provide transparency in hopes of reducing medical
errors, we have several concerns about the proposal. While some medical errors are obvious, other
outcomes are not so clear cut and therefore if reported as errors could mischaracterize the medical
event and produce inaccurate information. In addition, we are concerned about the limitations of
patient-centered data collection tools. If not properly worded, not in a format that users can easily
understand, and not properly paired with provider-reported data, these tools may result in inaccurate
information about patient safety events, excessive and misinformed malpractice claims, and other
actions that could unnecessarily harm the reputation of well-intentioned health professionals.
Over time, these unintended consequences could result in higher healthcare costs and lower quality
due to mistrust and frustration among health professionals in systems meant to improve care, all of
which, we believe, is the exact opposite of AHRQ’s intent. As AHRQ moves forward with efforts
to enhance the role of patient-reported data, the AOA requests that the agency keep in mind the
concerns outlined in this letter.
General Concerns
The document refers to adverse medical events and mistakes. How does ARHQ define adverse
medical event? It is possible to have an adverse medical event without it being a mistake. A
patient’s condition may not respond well to medication or a procedure provided by the physician. A
1

patient responding poorly to a treatment is not necessarily the result of a mistake. Does the patient
have enough medical knowledge to be able to identify and determine what caused an adverse
medical event as well as differentiate a mistake?
Through the CRSPS, AHRQ aims to collect patient-reported data on the details of a safety concern,
including when, where, and whether there was harm; the type of harm; contributing factors; and
whether the patient reported the event and to whom. While these are all valuable questions that can
provide important insight into quality, we worry about questions that rely heavily on what may too
often be conjecture rather than empirical evidence. While some medical “mistakes” are black and
white and can be easily identified by a patient (e.g., did your physician mix you up with another
patient? did your physician prescribe you a medicine to which you are allergic?), most are not.
Even questions as simple as “did you receive the wrong medicine or the wrong dose of medicine”
can be misinterpreted if the patient receives a therapeutically equivalent or generic drug with a
different name than was originally prescribed. The patient may not understand that the dispensed
drug and its adjusted dosage is an equal substitute to the originally prescribed drug. Similarly, a
physician may need to modify his/her care plan midway through a procedure due to unforeseen
events or discoveries. This is especially common in surgery. A patient may interpret such events as
having the “wrong surgery performed” even though the adjustment was clinically justified and most
likely resulted in better, more targeted care.
As such, we are concerned about questions that ask patients about whether they received the wrong
diagnosis or advice. While many patients are engaged stakeholders who seek out information
regarding clinical diagnoses, symptoms, and treatments, most simply do not have the same level of
expertise as clinically trained professionals and may not have the knowledge base to determine
whether a diagnosis was “wrong” or why the diagnosis may have changed during the course of care.
We recognize that these challenges could be mitigated with proper communication between the
patient and physician. For example, if a physician clearly explains to a patient that he is prescribing a
therapeutically equivalent drug because it is cheaper and has fewer side effects, the patient would not
be alarmed when the bottle listed a different name or dosage for the drug. However, the CRSPS, as
currently written, does not sufficiently capture whether and to what extent these conversations
occurred.
The AOA is equally concerned about questions that ask patients about “contributing factors.” We
are concerned that, in some (but certainly not all) cases, a patient or family member may not have
the clinical knowledge base or sufficient understanding of the healthcare system to accurately
identify why a mistake happened. In question #5.1 of the web-intake form, for example, the survey
asks the patient to identify why a mistake or negative effect may have happened and then provides
the patient with a list of reasons to choose from, instructing the patient to “check all that apply.”
This strategy essentially feeds patients answers that may sound logical and appropriate on paper, but
which may have never crossed the patient’s mind or may have had very little or nothing to do with
the original incident. Additionally, some of the reasons, such as “health care provider was too busy”
or “health care providers failed to work together,” seem to rely more heavily on subjective rather
than objective conclusions. Even if a patient claims to have directly observed a “busy” provider, it is
difficult for the patient to know with certainty that an incident occurred as a direct result of the
provider being too busy. Will those who fill out this survey be required to provide documentation
to support their claims? Would the selection of answers provide the data necessary to pinpoint the
cause of medical errors?
2

Despite these concerns, the AOA believes that many of the reasons listed as answers to question
#5.1 on the web-intake form, such as “health care provider did not communicate well with patient”
or “health care providers did not follow up with the patient” are important factors to consider that
can provide valuable insight for providers and minimize the chance of these incidents occurring
again in the future. As such, we recommend that AHRQ keep this question open-ended rather than
supplying patients with pre-constructed reasons for why an incident may have occurred. This would
give patients the opportunity to explain in their own words why an incident may have happened and,
if applicable, to acknowledge that they are not sure about the reasons why. Analysts could then go
back and evaluate which category of reason a patient’s response falls into in order to identify
patterns across healthcare settings regarding potential contributors to medical mistakes. While this
strategy would not necessarily work in a more scientific study, AHRQ mentions multiple times in its
supporting statements to the Office of Management and Budget (OMB) that “this is not a statistical
survey, but a convenience sample for a demonstration project” that will help AHRQ to better
understand effective methods of engaging consumers in reporting health-related safety events, both
through structured and narrative reports. Therefore, we believe that heavier reliance on open-ended
questions is appropriate and necessary.
Specific Recommendations
Listed below are brief comments and suggestions about other specific survey questions. All question
numbers refer to the web version of the intake form:
3.1.2.2. Did the mistake with a test, procedure, or surgery involve any of the following?
PLEASE CHECK ALL THAT APPLY
In line with our previously stated concerns, we believe that some of the responses to this question
may be too subjective, such as “the test, procedure, or surgery was delayed unnecessarily” and “it
took too long for the patient to get the results.” The same wait time may be interpreted by one
patient as appropriate while another may view it as inappropriate.
3.1.3.1 Did the mistake with the diagnosis or medical advice involve any of the following?
PLEASE CHECK ALL THAT APPLY.
• Wrong diagnosis
• Delayed diagnosis
• Bad medical advice
• Something else _____
Again, this question rests much too heavily on subjectivity and may be widely interpreted by
patients. At the very least, we recommend that AHRQ explicitly define the terms “wrong diagnosis”
and “delayed diagnosis” or at least request that patients provide their own definition or more
detailed explanation should they check either of these boxes. We also recommend that AHRQ
simply remove the term “bad medical advice” since it is much too vague to result in any useful
information. We believe that patients would have the opportunity to discuss what they interpret as
“bad medical advice” in the open ended final question.
3.3 Would you like to tell us the name and address of the health care doctor, nurse, or other
health care provider (or the health care facility) involved in the mistake?
3

While this information could serve an important purpose if reported accurately, the AOA is
concerned about patients who may wrongly identify a provider when they are unsure of who,
exactly, was involved in the incident. For example, if there was a perceived delayed or mis-diagnosis
and the reasons for this were not explained to the patient, how would the patient know whether it
was the fault of the physician, the lab interpreting the test results, or another member of the
healthcare team? Furthermore, many delays and other incidents are often the result of system-wide
failures and not necessarily the fault of any single care provider. The current response choices for
this question are “yes” or “no.” To minimize these concerns, we recommend that AHRQ at least
add a third response that states, “I am not sure who was involved in the mistake.”
3.4

How did the patient find out that the mistake [or negative effect] happened? (Please
choose the one answer that fits best.)
• The patient noticed it.
• A friend or family member noticed it and told the patient.
• A doctor, nurse, or other health care provider told the patient about it.
• An administrator or manager told the patient about it.
• The patient found out in some other way. ÆHow did patient find out?
• The patient never knew about it.
The AOA believes this question is critically important since it will help determine the accuracy or at
least the level of subjectivity that may have factored into the patient’s other responses, which we
expressed concerns about above. Collecting this information will also allow AHRQ to better match
patient reports with information collected by providers, to determine the extent to which these two
sources may differ, and to develop ways to ascertain more complete or more detailed information
from patients. We cannot overemphasize the importance of matching patient reported data with
information provided by healthcare professionals and documented in medical records.
3.5

Did a doctor, nurse, or other health care provider make any special effort to help the
patient handle the mistake?
• Yes
• No
• Don’t know

3.7.1

Did it help?
• Yes
• No
• Don’t know
While we believe these questions focus on important information, we feel they could result in even
more useful data if they asked the patient to explain, in his/her own words, how the provider made
a special effort to help the patient handle the mistake.
3.8
Did the mistake [or negative effect] affect the patient financially?
Again, this question should ask the patient to explain exactly how it affected them financially since
the question, as currently stated, is open to broad interpretation. The more detailed information
gleaned from the patient, the better policymakers will understand the factors contributing to safety
events and medical mistakes and the effect they have on patients.
4

4.2.1

What kind of physical negative effect did the patient experience? PLEASE CHECK
ALL THAT APPLY.
• Dizziness
• Sick to the stomach (nausea)
• Infection
• Pain
• A fall that caused an injury
• Open sores on skin
• A sexual problem
• Blood clot
• Uncontrolled bleeding
• Breathing difficulty
• Numbness or weakness
• Injury to teeth
• Injury to an eye
• Burn
• Heart attack or stroke
• Other physical effect____
• The negative effect was not physical
Many of these answer choices do not accurately capture the reason for the negative effect. For
example, open sores or an infection could be the result of patient noncompliance with wound care.
Furthermore, many of these physical effects may be unrelated to the original procedure even though
to the patient they appear to be related.
5.2 Is there anything else that caused the mistake or negative effect to happen?
The AOA recommends that AHRQ modify this statement so it reads, “Is there anything else that
may have caused the mistake or negative effect to happen?”
Additional Factors

We are concerned that this questionnaire, although it has good intentions, could lead to misleading
information about the health care provider’s quality of care. How will this information be
quantified? Will documentation back up the claims? What protections will be provided to the
physician or hospital against false claims? The questionnaire raises other questions. For example,
how exactly will the federal government use this information; to what extent will this information be
made public; how will the privacy of the patients and providers be protected; can this information
be used in medical malpractice lawsuits?
The AOA encourages AHRQ to keep in mind that while the current lack of patient reporting
mechanisms may contribute to a large number of adverse medical events that continue to go
unreported, it is not the only contributing factor and not the only part of the system that needs to be
improved in order to minimize medical errors. Healthcare professionals fear career-threatening
disciplinary actions and possible malpractice litigation, and clinicians working in a culture of blame
and punishment do not report all errors. The current system, which does not always protect
5

reporters of errors or near misses from negative consequences, only reinforces this fear. While
AHRQ assures protections of confidentiality for the patient under this pilot, it is not clear to what
extent healthcare professionals will be protected. As such, we are greatly concerned that AHRQ’s
proposed patient safety reporting system could give rise to greater malpractice suits, increase the
cost of liability insurance, and decrease the quality of health care for the patient.
We thank AHRQ for its tireless efforts to date to implement the provisions of the Patient Safety and
Quality Improvement Act of 2005, which encourages clinicians and health care organizations to
voluntarily report and share quality and patient safety information without fear of legal discovery.
We believe this is a step in the right direction, and we look forward to working with AHRQ to
develop Common Formats for other settings, such as physician offices. Still, many healthcare
organizations continue to find it challenging to provide an environment in which it is safe to admit
errors and understand why the errors occurred. We encourage AHRQ to continue working towards
a system that encourages a culture of safety rather than individual blame. Reporting should take
place in a confidential, non-punitive environment that incorporates follow-up actions, which foster
education and promote iterative system improvements.
The AOA appreciates AHRQ embarking on this important project, and we look forward to working
with the agency to promote patient-reported data and to minimize safety events in healthcare.
Should AHRQ have any questions about our comments, please feel free to contact: Carol Monaco,
AOA Director of Federal Affairs, at 202-414-0145.
Sincerely,

Ray E. Stowers, DO
AOA President

6

From:
To:
Subject:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection;
Comment Request
Wednesday, October 31, 2012 10:24:23 AM

Date:

comments
From: Flashner, Gary M. (ELS-STP) [mailto:[email protected]]
Sent: Monday, October 29, 2012 1:47 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Agency for Healthcare Research and Quality Agency Information Collection Activities:
Proposed Collection; Comment Request

Dear Ms. Lefkowitz:
I am writing in response to the Comment Request posted in the Federal Register on
October 5, 2012 as regards the AHRQ Information Collection Activities
(https://www.federalregister.gov/articles/2012/10/05/2012-24454/agency-forhealthcare-research-and-quality-agency-information-collection-activities-proposed).
I serve as Vice President of Medical Content for ExitCare, an Elsevier company that
develops, maintains, and translates a library of health education materials. I speak
for our entire Minnesota-based organization by saying that we appreciate the
opportunity to provide feedback and suggestions regarding the project and tasks
outlined by the AHRQ.
ExitCare completely agrees with the following statements by the AHRQ:
“In order to fulfill the promise of EHRs for all patients, especially for persons
with limited health literacy, clinicians should have a method to determine how
easy a health education material is for patients to understand and act on, have
access to a library of easy-to-understand and actionable materials, understand
the relevant capabilities and features of EHRs to provide effective patient
education, and be made aware of these resources and information.”
ExitCare respectfully disagrees with the following premise that is included in the
Federal Register posting:
“However, health education materials delivered by EHRs, when available, are
rarely written in a way that is understandable and actionable for patients with
basic or below basic health literacy.”

After a careful and detailed analysis, it was determined that, in order to provide
productive feedback regarding the validity of the HIRS, suggested revisions for the
HIRS, and the associated estimated burden, it would be most helpful if the AHRQ
would clarify a few items:
1. What criteria did the TEP use to determine “understandability” and
“actionability” when rating the 12 patient education materials that were

evaluated? It is important to note that quantifiable factors used for the
development of effective print material are different than those used to
develop audiovisual material.
2. What is the background of those on the Technical Expert Panel? Is the
group made up of clinicians, professional educators, others?
Thank you for your time and attention. We look forward to your feedback.
Sincerely,
Gary M. Flashner, M.S. M.D. ABFP
Vice President, Medical Content
Elsevier/ExitCare
Toll-Free +1.800.694.6669, ext. 520 | Direct +1.714.375.9420 | Mobile +1.714.742.9420
[email protected]

8519 Eagle Point Blvd., Ste 105
Lake Elmo, MN 55042

Remote Office:
6152 Warner Ave., Suite A
Huntington Beach, CA 92647

Elsevier – helping you provide safe, quality care for optimal patient outcomes.

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Patient reporting of errors mostly a bad idea.
Thursday, October 25, 2012 8:47:51 AM

comment
From: [email protected] [mailto:[email protected]]
Sent: Wednesday, October 24, 2012 8:48 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Patient reporting of errors mostly a bad idea.

I'm a registered nurse in a private hospital in Oregon (btw, there's only two) and I always
strive for perfection in my practice. I also sometimes catch flack for taking too much time to
provide superior care in whatever I do. Let's be frank, most hospital errors occur because
there is just simple too much work to be done by too few of staff(including physicians and
nursing). I would love to think that patient reporting of errors is a wonderful idea and that it
would lead to hospitals' upper management being held accountable for inappropriate staffing
levels to help reduce errors. But let me tell you, many of these patients we take care of would
be completely unreliable to be trusted to report errors accurately. Many patients are sick
because of diagnosed and undiagnosed mental conditions they suffer from and are very
unhealthy mentally and nutritionally. Comparatively, you are much less likely to see a welladjusted, "normal" adult sick in the hospital, there's a reason for that. Then you have the very
biased family equation to mix in. Many family members of sick people whether they be
elderly, spousal, or children, just aren't as rational in these situations as they are in the rest of
their lives(believe me, I've been there several times). Also, you must take into account that
most just don't understand enough about medical care to know even if an error occurred or
even how to report it to where anybody can understand the information. You will also see
major abuses of the reporting from chronically dissatisfied people.
My suggestion is to have an error reporting law/system where medical professionals can
report errors they see easily and confidentially in addition to the current organized reporting
systems now in place. I assure you, most professional healthcare workers would want to
report what goes on if they believe it would lead to better care and hence a better
environment to work in. It would also be important that specific information not be requested
since this could be traced back to a department and an employee trying to do the right thing.
Maybe a third part of this system can be a patient reporting of errors, but this could make it
less likely that a staff member would want to report an error too because it could lead to
identification of the reporting staff member.
My two cents,
Corey RN

From:
To:
Subject:
Date:

Robbie
Roemer, Marc I. (AHRQ)
Re: A Prototype Consumer Reporting System for Patient Safety Events
Friday, September 28, 2012 12:19:31 PM

aren't u a sweetie.
Could u plssssss forward my note to d lefkowitz.
I worked in the system until my retirement and I can tell you that
nothing-zero will come of this study. That is why people are so bold in
harming patients and also why incidents are not reported.
The only thing that will change this nonsense is elevating patient boldness
by EDUCATING THE PATIENT. Lack of knowledge and courage will kill in the
medical field. Please greed to that list.
-----Original Message----From: Roemer, Marc I. (AHRQ)
Sent: Friday, September 28, 2012 6:49 AM Subject: A Prototype Consumer
Reporting System for Patient Safety Events
We received your note describing your experience with the medical care
system. The recent articles in the news media that you referred to in your
letter described a pilot study that AHRQ expects to conduct next year.
At this time, AHRQ has announced this new activity in the Federal Register
and is open to receiving comments through November 9, 2012. The Federal
Register Notice as well as documents describing the study are attached to
this letter. If you wish to submit comments about this project you may send
them to Doris Lefkowitz at AHRQ through email. Her email address is
[email protected].
Thank you for your interest in AHRQ and in this important project.
Marc Roemer
Agency for Healthcare Research and Quality
[email protected]

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Agency for Healthcare Research and Quality"s (AHRQ) public commentary
Tuesday, October 16, 2012 10:16:45 AM

comment
From: Tami [mailto:[email protected]]
Sent: Monday, October 15, 2012 4:41 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Agency for Healthcare Research and Quality's (AHRQ) public commentary

Doris,
I think this is a WONDERFUL reporting system for the patient, as well as the family
health advocate.
I would have loved to have this system in place to report several incidences of error
when my mother was in the hospital.
Consumers of health care should have this reporting system to make everyone aware
of each facilities margin of error.
I feel the proposed system could very well serve the public, as well as a grade marker
for hospitals to ensure better care and follow-up.
I strongly support the implementation of a central healthcare reporting system.
Sincerely,
Tami McCrystal

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: CTS-1503
Wednesday, October 24, 2012 2:42:47 PM
2012-C-1503.zip

Comments
From: Nunley, Cindy E. (AHRQ)
Sent: Wednesday, October 24, 2012 10:42 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: FW: CTS-1503

Reminder…this is due today. Thanks.
From: Fatigati, Cathy (AHRQ)
Sent: Friday, October 12, 2012 10:16 AM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Nunley, Cindy E. (AHRQ)
Subject: CTS-1503

Hi Doris,
This CTS from the OD was addressed to you for response. The due date is 10/24/2012.

Page I of2

Untitled Document

Secretary's Corres pondence
DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF THE SECRETARY
EXECUTIVE SECRETARIAT
OS#:

092520121006

From:

Hess, Lisa

City/ State:

Cedar Rapids lA

Synopsis:
Subject Tags:

9/23/2012

([email protected])

On Behalf or
Subject:

Da te on Letter:

Date Received: 9/25/2012
Type:

General Public

EMAIL: Writer raises her concerns with language that is
used to desccribe the possible 'reasons' for medical errors.
She feels that the options are adversarial at best.
Healthcare already suffers from poor communication
between patients and their health care providers and she
provide possible alternatives. She requests a response
back to her concerns and comments.
email

Assigned to:
AHRQ
Lauren Underwood
PC:
Action Required : Direct Reply

Date Assigned:
9/27/2012
Date Reassigned: 10111/2012
Reply Due Date: 10/25/2012

tnfo Copies To:

Lisa Bauman; Underwood, Lauren (HHS/IOS)

Interim (YIN):

No

Comments:

Date Interim Sent:

10/11112-Per CMS: The New York Times composed an article
based on the White House drafting a Pilot where consumers
would report medical mistakes. The article prompted the
writer to submit a letter which comments on language used
in the drafted reporting system (questionnaire). The pilot is
awaiting approval from the White house and has not been
assigned to an Agency. eMS reviewed this request and we
determined that this control does not fall in our purview. We
suggest OSIES check with AHRQ. Thanks! LO

hnps:IIswift. hhs.gov/swiftlwdslcss.asp?OSNum=092520 12 1006&DocT ypel D=8& Packet...

10/ 11 1201 2

Page2or2

Untitled Document

File Index:

eee:

Laura ONeill

hnps://swi ft.hhs.gov/swiftiwdslcss.asp?OSNum=092520 121006&DocTypeID=8&Packet...

10111 /20 12

Page 1 of 1

Information Copy Cover

Department of Health and Human Services
Office of the Secretary
Executive Secretariat

Information Copy
Date:
Assigned
Agency!s):
Task
Recipient!s):
Information
Copies:
Assigned PC:

Subject:

1011112012

OS#:

092520121006

AHRQ

Task Type : Initial Authoring

eMS; AHRQ

Action
Required:

Direct Reply

Lisa Bauman; Underwood, Lauren (HHSIIOS)
Underwood, Lauren
Policy Coordinator
Secretary's Correspondence
Incoming from: Lisa Hess
EMAIL: Writer raises her concerns with language that is used
to desccribe the possible 'reasons' for medical errors. She
feels that the options are adversarial at best. Healthcare
already suffers from poor communication between patients
and their healthcare providers and she provide possible
alternatives. She requests a response back to her concerns
and comments.

Synopsis:
Subject Tags: email
File Index:

eee:

ONeill, Laura

Information Only; No Action Required
Instructions: The New York Times composed an article based on the White House
drafting a Pilot where consumers would report medical mistakes. The article
prompted the writer to submit a letter which comments on language used in the
drafted reporti ng system (q uestionnaire). The pilot is awaiting approva l from the
White house and has not been assigned to an Agency. eMS reviewed this request
and we determined that this control does not fall in our purview. We suggest
OSIES check with AHRQ. Thanks '

Th ank you for you r cooperation.

Attachments

https:lIswi ft.hhs.gov/swiftlwd slcss.asp?OSNum~092520 t 21006&DocTypel D~ 8&Packet...

10/ 11 /2012

••• RECEIVED •••

t""'-,
~.

j~~

,

, -,

From:
Sent:
To:
Subject:

Sep 25.2012 09:3 1:35 Ws. 20
OSNUM: 0925201 21006
955'es 95 TIfF S5GS5HSX

Sebelius, Kathleen (H HS/OS) [Kathleen [email protected]
Sunday, September 23, 2012 3.17 PM
OS Oshhsexecsec2
FW: Patient safety

CORRESPONDENCE
CONTROl CENTER

From: lisa Hess[SMTP: lH [email protected]
Sent: Sunday, September 23, 20123:16:49 PM
To : Sebelius, Kathleen (HH S/OS)
Subject: Patient safety
Auto forwarded by a Rule

The Honorable Kath leen Sebelius,

I am writing in regards to a recent NY times article describing a pilot project to encourage patients and
fami ly members to report medical errors. (pear, R. (20 12,Sept.22) New System for Patients to Report
Medical Mistakes. The New York Times. Retrieved from htt p://nvti.mslQuZh jD). I am a practicing
08/Gyn. in Cedar Rap ids, Iowa and am very interested in improving patient safety. I agree that it is
important to engage patients and their families in this process . I am intrigued by the pilot project that is
described where patients or fam ily members can respond to a questionnaire regarding possible medical
errors. The article states that the questionnaire asks "why the mistake happened and lists possible
reasons:
"A doctor, nurse or other hea lth care provider did not comm unicate well with the patient or the patient's
family."
" A health care provider didn 't respect the patient 's race, language or culture."
"A health care provider didn't seem to care about the patient."
."A health care provider was too busy."
"A health care provider didn't spend enough time with the patient."
"Health care providers fai led to work together."
"Health care providers were not aware of care received someplace else."
My concern is the language that is used to describe the possible "reasons" [or medical errors. I fee l that

the options are adversarial at best. Healthcare already suffers from poor communication between
patients and the ir healthcare providers and I feel that the way these " possible reasons fo r medical errors"
are stated conti nues the tradi tion of creating blame and shame when an error occurs whic h, I fee l, is why
adverse medical events are poorly reported. This culture of blaming and shaming the healthcare tea~

••• RECEIVED •••

Sep 25,2012 09:31:35 WS# 20

when adverse events occur also contributes to the
healthcare providers.

a~nrl~AAship

between patients and

CORRESPONDENCE
CONTROL CENTER

I have recently started a Masters program in Dispute and Conflict Resolution through Creighton
University. In this program we learn about how important it is to commun·icate clearly and also how
difficult this is to achieve. We studied an interesting example of successful dispute resolution policies
within the online company eBay. eBay was able to create a dispute resolution system that now handles
tens of millions of disputes yearly with great participant satisfaction. One of the most important things
that contributed to the success of this program was the way disputes were described. Rather then stating
"sender did not ship item" they provided a category "item not received", likewise disputes regarding lack
of payment by the buyer were no longer categorized as "deadbeat buyer" but as "payment not received"
(Rule, C. (2008, Fall). Making Peace on eBay: Resolving Disputes in the World's Largest Marketplace.
ACReso/ution. Retrieved from www.ACRnet.org.). By removing the aspect of blame inherent in the
original terms, the emotional component of the dispute was dissipated and the actual problem could be
addressed. I feel this is a tool that this project could benefit from. Rather than stating "(a) health care
provider didn't respect the patient's race, language or culture" why not ask:
"Did you feel that there was difficulty communicating with the healthcare team?
Was the difficulty due to :
Terminology: it was difficult to understand what the healthcare team was saying because of medical
terminology.
Language: English is not my native language or, English was not my doctor'/nurse's native languagehe/she had an accent I could not understand.
Culture: I was uncomfortable with the health care team's medical treatment-plan because it required me
to do things that I don't believe are right."
Likewise the phrase "(h)ealth care providers failed to work together" could be transformed into "Did you
feel you healthcare team had all the information they needed to take care of you? If no, which sentence
best characterizes your situation?
I felt that the healthcare team did not have the information from the tests I had performed during my
current hospitalization.
I felt that the healthcare team did not have information from my doctor's office.
I felt the healthcare team did not have information from my previous hospital stays."
. By removing the blame and emotional triggers in the wording of the questions, the infonnation that is
received will likely be more useful for addressing medical "errors" and will also establish a working
.. relationship between patients, their families and their healthcare teams to provide safe medical care .
. Thank-you for your time and consideration and I look forward to your response,
Sincerely,
2

•• , RECEWED •••

l;.iia Hess, MD

Sep 25.2012 09:31 :35 W$# 20
QSNUM: 092520121006
OFF ICE OF T HE SECRETARY
CORRESPONDENCE
CONTROL CENTER

[email protected]

3

Initial Aut ho ring Round 1 Response 2416385.1 from CMS[l]
The New York Times composed an article based on the white House drafting a pilot
where consumers would report medical mistakes. The article prompted t he writer to
submit a letter which comments on language used in the drafted reporting system
(question naire). The pilot is awaiting approval from the white house and has not
been assigned to an Agency. eMS reviewed t his request and we determined t hat this
control does not fall in our purview . We suggest OS/ES check with AHRQ. Thanks!

page 1

New System for Patients to Report Medical Mistakes ~ NYTimes.com

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Susan Chandler
10/05/2012 10:59 AM
RE: Patient Harm

Thank you for your comments. If you would like to review all the study materials please let me know and I will
provide them
From: Susan Chandler [mailto:[email protected]]
Sent: Friday, October 05, 2012 10:58 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Patient Harm

Ms Lefkowitz,
Having just read an article a non-clinical colleague just shared with me about patient
harm, I would like to share a few comments with you.
As a health care professional: We take safety seriously. It is the mission of our health
system to one day be the safest hospital in America. We have educated all our
employees from CEO to Environmental Services to Volunteers about safety and
given them safety tools to use. As leaders, we recognize and reward publically those
"caught in the act" of preventing harm. I'm proud to be part of a system that takes
patient safety so seriously.

As a consumer of healthcare services, it's obvious we have a long way to go. During
a recent hospitalization for my husband, despite all the safety initiatives, if I had not
been for my presence to advocate for him, there could have been multiple
opportunities for medical errors. From my standpoint, one of the most essential areas
for us to improve is medication safety. That was demonstrated to my by the nurse
administering medications to the hospitalist preparing him for discharge. If I were to
do a cursory root cause analysis, I would explain it as poor communication.
I am a strong advocate of voluntary reporting systems for medical errors and near
misses. Part of my responsibility as to monitor those for trends and issues for our
large outpatient clinic system. On more than one occasion we have been able to
recognize patterns and intervene before harm or unintended outcomes occurred.
These systems may not be perfect, but they are a step in the right direction. The
opportunity for consumers to have a voice is a component that is missing in this
process. I encourage AHRQ to consider the possibility of adding patients who have
experienced harm to our reporting systems.
Thank you,
Susan Chandler, MS, RN-BC
Nurse Clinician, Ambulatory Care Clinics
VCU Health System

(804) 827-3961, pager 373-0583/6576
Fax: 827-8411, [email protected]
NOTE: The information contained in this message may be privileged and confidential and protected
from disclosure. If the reader of this message is not the intended recipient, you are hereby notified that
any dissemination, distribution or copying of this communication is strictly prohibited. If you have
received this communication in error, please notify us immediately by replying to the message and
deleting it from your computer.
-------------------------------------VCU Health System
http://www.vcuhealth.org
NOTE: The information contained in this message may be privileged and confidential and protected
from disclosure. If the reader of this message is not the intended recipient, you are hereby notified that
any dissemination, distribution or copying of this communication is strictly prohibited. If you have
received this communication in error, please notify us immediately by replying to the message and
deleting it from your computer.
-------------------------------------VCU Health System
http://www.vcuhealth.org

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Public Comment on Proposed Information Collection
Tuesday, October 02, 2012 3:17:40 PM

From: Samuel Mahaffy [mailto:[email protected]]
Sent: Tuesday, October 02, 2012 3:13 PM
To: Lefkowitz, Doris C. (AHRQ)
Cc: [email protected]
Subject: Public Comment on Proposed Information Collection

To: Department of Health and Human Services
Agency for Healthcare Research and Quality
Dear AHRQ:
I write in public comment to strongly support the development of a prototype Consumer
Reporting System for Patient Safety Events. I am a charter board member of the Washington
Advocates for Patient Safety, a non-profit organized in the State of Washington. Our board
is comprised entirely of individuals who have experienced significant harm as a result of
medical error or adverse medical events. Very often these events are not reported either
because the experience of the patient or their family is not solicited, much less listened to by
health care providers or the medical provider does not consider themselves obligated to
report the event. Collection and reporting of information from health care consumers
empowers members of the public to be advocating for their own health and safety and that of
the public at large. It increases accountability of providers while not placing an undue
burden.
I strongly support the efforts of AHRQ to move forward with the Prototype Consumer
Reporting System for Patient Safety Events.
Respectfully submitted,
Samuel Mahaffy, Executive Director
GRE Consulting Associates
[email protected]
Charter Board Member: Washington Advocates for Patient Safety

From:
To:
Subject:
Date:

[email protected]
Roemer, Marc I. (AHRQ)
Re: FW: Proposal for consumer reporting system for patient safety events
Tuesday, October 02, 2012 2:22:49 PM

Marc, Thank you very much for the documents. I will read them and get my comments in.
Thanks again!
Yanling
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
On Mon, 1 Oct 2012, Roemer, Marc I. (AHRQ) wrote:
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Yanling, thank you for your interest in this project "A Prototype Consumer Reporting System for

Patient Safety Events." I have attached all of the documentation. Please note that Supporting Statement
Part B is in draft form at this time. Because the project is still under review, other documents and/or
questionnaires may change as well.
>
> Marc Roemer
> Agency for Healthcare Research and Quality
> [email protected]
>
>
> -----Original Message----> From: [email protected] [mailto:[email protected]]
> Sent: Saturday, September 29, 2012 11:45 PM
> To: Lefkowitz, Doris C. (AHRQ)
> Subject: Proposal for consumer reporting system for patient safety events
>
> Dear Ms. Lefkowitz,
>
> I am very interested in this AHRQ proposal and would like to get copies of the proposed collection
plans, data collection instruments, and specific details on the estimated burden.
>
> Thank you so much for your assistance.
>
> Sincerely,
>
> Yanling Yu
>
> washingtonadvocatesforpatientsafety.org
>

From:
To:
Subject:
Date:
Attachments:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Alert: New Task Assigned to Me and Others.
Tuesday, October 02, 2012 11:56:45 AM
Incoming 1448.pdf

From: Nunley, Cindy E. (AHRQ)
Sent: Tuesday, October 02, 2012 9:54 AM
To: Lefkowitz, Doris C. (AHRQ)
Cc: Cohen, Steven B. (AHRQ)
Subject: FW: Alert: New Task Assigned to Me and Others.

Doris,
Attached is letter from Congressman Bill Cassidy to Carolyn under control 1448, due 10/16. We are
to provide input for CQUIPS to prepare Carolyn’s response. Please copy me when you send it to
Steve for review. Thanks.
Cindy

Perry, Wendy (AHRQ)

Subj ect:
Attachments:

Migdail , Karen J. (AHRQ)
Monday, October 01 ,20126:03 PM
Ginieczki, Boyce (AHRQ)
Henry, Diana (AHRQ); Clancy, Carolyn M. (AHRQ); Holland , Howard (AHRQ); Perry, Wendy
(AHRQ); Zucker, Phyllis M. (AHRQ)
Fw: Congressman Bill Cassidy Letter to Dr. Clancy
10.1.12 - Be et al to Clancy reomedical errors.pdf

Im portan ce:

High

From :

Sent:
To :
Cc:

Fyi ...

From : Henry, Diana (AHRQ)

Sent : Monday, October 01,2012 05:58 PM
To: Clancy, Carolyn M. (AHRQ)
Cc : Migdail, Karen J. (AHRQ); Zucker, Phyllis M. (AHRQ); Holland, Howard (AHRQ); Perry, Wendy (AHRQ)
Subj ect: FW: Congressman Bill Cassidy letter to Dr . Clancy

Carolyn:
I have printed out a copy and put on your desk for tomorrow. I have also forwarded to Wendy to
log into the control system.

Diana
Diana Henry
Executive Assistant
Or. Carolyn Clancy. Director
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville. MD 20850
PHONE: 301-427-1203
FAX: 301-427-1210
EMAIL: [email protected]

From: Austin, Courtney [mailto:[email protected]]
Sent: Monday, October 01, 2012 10:05 AM
To: Henry, Diana (AHRQ)
Subject: Congressman Bill cassidy letter to Dr. Caney

Courtney Aust in
Legislative Director
Congressman Bill Cassidy, LA 06

(202) 225-3901
Click Here to sign up for Congressman Cassidy's E-Newsletter

You
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October 1, 2012
Dr. Carolyn Clancy
Director
Agency for Healthcare Research and Quality
United States Department of Health and Human Services
540 Gaither Rd
Suite 3000
Rockville, Maryland 20850
Dear Dr. Clancy,
The New York Times recently reported that the Administration is considering a proposed system
developed by your agency for patients to voluntarily self-report medical errors by health care
providers, including doctors, hospitals, and pharmacists to the federal government. While the
goal of providing greater transparency to patients is a noble one, we have significant concerns
that this proposal could undermine that goal by producing inaccurate infonnation.
While it is important to understand the subjective patient experience of care, it would be
inaccurate to use this information as an objective standard of care. Many patients do not have the
medical knowledge to accurately determine when an adverse medical event occurs. If an adverse
medical event does occur, there is a likelihood that the patient could mischaracterize it.
Moreover, the reporting system presented in the article could give rise to under-reporting adverse
medical events in certain circumstances and over-reporting in others. Such inaccurate and
incomplete data would only produce misleading information about medical provider quality.
The article indicates the questionnaire consists of very vague language. For example, it asks
patients why a mistake happened and asks them to pick reasons such as "A health care provider
was too busy" or "health care providers failed to work together." This does not appear to be the
kind of empirical data required to get at the heart of why adverse medical events occur on a
system-wide scale.
Additionally, we have concerns that such a reporting system could give rise to greater medical
malpractice liability insurance costs. This could increase costs and decrease quality of health care
for patients.

The article indicates that) not only did your agency share the draft questionnaire with a reporter)
hut also many stakeholders as well, such as the American Hospital Association, the American
Academy of Orthopedic Surgeons, and Project Patient Care. We would respectfully ask that you
share the draft questionnaire with Congress as well.
In addition, we would ask thal you please address the following questions by October 20th, 2012:
•
•
•
•
•

How exactly will this information be used by the federal goverrunent?
WiU the federal government maintain a database of this information? If so, what will be
its purpose and who will have access to it?
To what extent will the information reported in this questioIIDaire be made public?
How will the federal government protect the privacy of patients and providers?
How spl.'Cifieally will you ensure that the information provided cannot he used in
medical malpractice litigation?

Thank you in advance for your answers to the listed questions. We look forward to working with
you in the future to ensure a lower cost, better quality and a more transparent health care system.

Sincerely,

Tom Coburn, M.D. (OK)
United States Senator

United States Senator

United States Representative

Ron Paul, M.D. (TX-14)
United States Representative

mOt>. A. .. Q.

Paul Broun, M.D. (GA-IO)
United States Representative

•

States Representative

B.L/a&~
Phil Roe,
M.D. (TN- I)
United States Representative

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comment : A Prototype Consumer Reporting System for Patient Safety Events
Tuesday, October 02, 2012 8:43:55 AM

File with comments
From: Martha Deed [mailto:[email protected]]
Sent: Monday, October 01, 2012 8:15 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comment : A Prototype Consumer Reporting System for Patient Safety Events

Martha L. Deed, PhD
1037 Sweeney Street
North Tonawanda, NY 14120
[email protected]
Dear Doris Lefkowitz-Thank you for this opportunity to respond to this proposal (Federal Register, September 10, 2012,
55475 ff).
I am a Psychologist (Retired), licensed in New York State, who has participated in research under
federal, state, and private foundation grants in the area of legislative and justice responses to Family
Violence. I became active in the patient safety field because five close family members have
developed HAIs since 2001: Father died from MRSA in 2001. Mother died of multiple infections
acquired in a nursing home and hospital in 2008. Both lived in Nyack, New York. A brother
developed hospital-acquired MRSA sepsis in 2007 in Connecticut. He survived with no ongoing
cardiac damage. My uncle died of hospital-acquired MRSA in Oklahoma, 2010. My daughter (and
only biological child) died of multiple hospital-acquired infections and an undiagnosed spinal
infection in 2009 in Williamsville, NY.
My family's experience informs me that patient safety issues are widespread, have been widespread
for more than a decade, and are not adequately addressed by current efforts to collect data from
providers and to develop provider-centered measures for preventing patient safety errors as defined
by CMS.
You ask for comment on
(a) Whether the proposed collection of information is necessary for the proper performance of
AHRQ health care research and health care information dissemination functions, including
whether the information will have practical utility
I agree that current methods of patient safety data collection are fundamentally-flawed. They
depend upon voluntary submission of adverse events by providers who perceive that their adverse
event reports could lead to liability issues, economic loss, and/or competitive disadvantage should
the information become public. In addition, such reports could result in reimbursement penalties by
CMS.
The result is that self-reporting by providers is likely weighted in the direction of significant underreporting.
(See, for example, http://www.thehospitalist.org/details/article/2360341/Most_Adverse_Events_at_Hospitals_Still_Go_Unreported.html)

Although a few states include mandatory reporting for some adverse events, state regulation does
not appear to be consistent throughout the country. The reporting requirements, including mandatory
reporting requirements, are further handicapped by funding limitations to audit the reports. (See for
example, https://oig.hhs.gov/oei/reports/oei-06-09-00360.pdf)
My family's experience, while anecdotal, suggests that the above concerns are well-founded. When
I reported my daughter's MRSA infection to the NYS health department, an investigator interviewed
the hospital's designated patient safety officer. The PSO told the investigator that my daughter
entered the ICU already positive for MRSA. That statement was contradicted by the hospital's
medical record for my daughter which showed that my daughter was cultured (blood, sputum, and
urine) for MRSA upon reaching the ER. All of those test results were negative. The PSO also
responded to an inquiry as to whether there was an unusually high incidence of MRSA in the ICU in
October-November 2009 -- by saying No (DOH report #10-06-322, pp. 6-7). But in 2011, the
hospital made reference to the high incidence of HAIs in the hospital during late 2009, stating that
levels were now significantly reduced ("Roswell Park and Kaleida say bloodstream infections ar
down," The Buffalo News, June 20, 2011).
Such incidents render provider-based adverse events reporting virtually useless. Lesson learned:
You cannot trust providers to report incidents that go against their own self-interest.
The practical utility of collecting patient safety information from consumers could add to the
accuracy of current estimates of frequency and impact of these incidents on individuals and families,
but only if the questions asked, manner of collection, and methods of working with and
disseminating the consumer information is adequate. (See my response to c below.)
(b) Estimates of burden. No comment.
(c) ways to enhance the quality, utility, and clarity of the information to be collected
First, I think the utility of the patient reports will depend greatly on how the information is collected,
how it is interpreted, and how well the public is informed about the results.
I realize that you are proposing a pilot project and not a final project with the most rigorous design.
However, voluntary submission of reports is not going to get you very far if you want to know what
sorts of adverse events are occurring and how often they are occurring. To draw those conclusions,
you need a well-defined sample of respondents. Using kiosks does not fulfill that very basic
condition. I strongly urge that the pilot study incorporate standard sample components, i.e. a welldefined denominator (all or a stated proportion of randomly selected patients) of whom a determined
sample receive questionnaires -- and then a comparison within those populations between responders
and non-responders to test the strength of the questionnaire findings.
An alternative approach, if you contemplate using a kiosk approach after the pilot study, would be to
perform both a kiosk and a defined sample distribution in some small geographic area (matched on
major variables) and then compare the results in terms of frequency and types of patient safety
adverse events reported by both groups. If the kiosk approach is found to be comparable to the
random sample distribution approach, I would feel better about what the kiosks reveal in terms of
significance and reliability. I suspect, however, the results between the two approaches would be
quite different.
I have followed the patient satisfaction survey approach fairly closely. I think that approach is truly
making a contribution both to hospitals' awareness of what they need to do to improve patient
satisfaction and in terms of patients making hospital choices based on the patient satisfaction reports

as disseminated on Health Compare. So, I hope this is where the proposed studies are headed.
If the patient safety surveys are not distributed via a well-defined sample and if the results are not
made easily accessible to the public, then the project may not be worth undertaking.
Second, your proposal to submit a subset of patient safety reports to the providers' patient safety
officer is particularly questionable. In my own family, we did not report patient safety issues
because my daughter believed (and I am sure she was correct) she would experience retaliation and
would find it more difficult to find the best care available in our area if she became identified as
someone who complains.
For a patient to submit a report to you and then for you to pass that report back to the provider's
patient safety officer simply amplifies the retaliation issue. Furthermore, in my experience (which is
limited, of course, but see above), I have some doubt whether the patient safety officer would shed
light on the issue.
Third, full public disclosure of the patient safety results is essential for improved patient safety. The
current research plan will not allow for comparisons among hospitals, and that point needs to be
made very clear. But even in the pilot study, it would be important to let the public know what sorts
of adverse events are being reported and where the reports are coming from. "Where" needs to be
exact -- not just "WNY hospital" which undercuts trust in all hospitals in the region, but precisely
which hospitals.
Once the patient safety reports are solicited the same way (or functionally with the same systematic
approach) as the patient satisfaction surveys, then the results should be made available on Hospital
Compare. But in the preliminary and pilot phase, the results can still be made public, but not as part
of a large database. They can be made public through the pilot study research report, and that report
should be made widely available on the web as well as publicized to print media via news releases.
(d) ways to minimize the burden of the collection of information upon the respondents
(I am focusing primarily on the providers' involvement with this project.)
In the data collection methods laid out in the proposed consumer reporting system, it appears that the
greatest burden might fall, not on consumer respondents but on the providers AHRQ contacts as a
result of the consumer reports. Yet, as indicated earlier, the current plan appears inadequate because
it places undue vulnerability on the patient responders without appreciably enhancing the strength of
their reports. Reasons for this design weakness include a perceived reluctance, backed by earlier
research, for providers to report adverse events. Going back to a provider with a patient-generated
adverse event report in hand which potentially places the provider in a "gotcha" embarrassing and
potentially vulnerable position with a regulatory agency could motivate retaliation against the
consumer reporter.
Yet, comparison of consumer and provider adverse event reporting is necessary to improving patient
safety. Therefore, it is critical to develop a data collection plan that will protect reporting
consumers, will provide the information needed to determine whether the provider has revealed the
adverse event, and will enable the researchers to determine whether the adverse event actually
occurred. Consumer identity protection needs to be balanced against making undue demands on
providers to locate and provide records. And -- privacy regulations must be adhered to as well.
The following modification might meet all three conditions:
What could be done, but would take more work and consequently require more funding, is to create
a request for adverse incidence reports from providers that would include the consumers who have

made a report along with a few records from patients who have not made reports but whose hospital
course included similarities to the participant patient. This might involve something along the
following lines: You have a report from patient X who was admitted to the cardiac unit of hospital
A on a particular date. You could request all incident reports for patients admitted to the cardiac unit
at hospital A on that date. To further reduce the volume -- you could further define the request to
include shared demographic characteristics, e.g. if the adverse event was a fall and the patient was a
woman -- all incidence reports of women falling who were admitted on such and so a day, etc. The
identifiers could be medical record number or birth date -- or some other piece of information that
could be included in the patients' report to you that would also be on the information submitted by
the provider.
The principle here would be to determine whether an adverse event report was filed for the consumer
participant as well as for other patients who might have experienced a similar incident. By
requesting all reports that fit a particular set of circumstances, the consumer is protected and the
researchers obtain necessary data.
You could leave the non-respondent reports unexamined, so for the researchers, the extra time would
be spent only to find the relevant report. But for the provider, providing those reports might add to
the time involved in participation. You could guard against laying undue burdens on already
overtaxed staff by defining the reports search as stringently as possible so that you might get 3
reports, not 20, that meet the conditions set out.
Comments regarding the packet of materials entitled "Consumer Reporting System for Patient
Safety"
I requested and have now received copies of the CRSP documents. (Limiting my remarks to
substantive issues.)
Attachment G Proposed flyer -- What does ECRI stand for? I don't think many people will be
familiar with ECRI. That confuses your message.
Attachment A -- Web pages. Good except for the reference to writing a "big report" -- which struck
me as very condescending. ECRI problem also
Attachment B -- Intake Reporting Form. Very good. Elicits the desired information in a clear
manner.
Attachment C-- FAQs: ECRI problem. Risks of Participating? I think something needs to be said
about how patients who permit contact with their health care providers will be protected from
retaliation -- and whether there is a way for the researchers to track possible retaliation. Limiting the
questionnaire for use only on Internet Explorer is a genuine limitation, which will cause some
potential participants not to respond. Many internet users (including me) have long since stopped
using IE because of security concerns. Many of us donot have IE installed on our computers any
longer. Most often used browsers appear to be Mozilla, Chrome, and Opera. Bing is less desirable
because of Google's propensity for collecting user data. So, you have created a barrier here.
Furthermore, limiting the ability to print out the questionnaire with the participant's answers only if
the participant has an Adobe file creater is likewise not a good plan. Most people do not have
Adobe creation software, and there are costs in obtaining the software. Much better to be able to
print using the browser's print utility. If you insist on a pdf file creator, you might consider
providing information on an open source software package if one is available.
Attachment D -- Good script. I do think there will be confusion because while the promise is to
maintain patient privacy, there is also a request to pass reports on to the patients' caretakers -- and
this would almost certainly destroy privacy. I also think that if the report is not made available to the
general public, it may limit patient participation.
Attachment E -- Intake reporting form. Good.
Attachment F -- Telephone follow-up. I would alter the script if the interviewer reaches someone
other than the respondent. I think that all references to patient safety should be omitted and the

caller merely state that they are calling in regard to a research question at (and name the entity). I
can think of many instances where other members of the responder's household would actually
object to participation in this research. Thus I believe people's participation in the research should
be kept confidential from everyone, including members of the participant's household. I consider the
current script to be a genuine breach of confidentiality.
Attachment H -- Matching consumer patient safety report with the consumer's health care provider - very important questions. But -- I don't see how it is safe to ask such questions about an identified
patient. (See my comments above.)
Supporting Statement, Part A -- convenience sample well-explained. Care with conducting
telephone interviews, e.g. making sure subject is in a space where they will not be overheard is
good. But more care (see above) needs to be made not to reveal subject's partiicpation to household
members. Not clear how report will be distributed and how complete public access to results will
be. I consider public disclosure to be an essential element.
Supporting Statement, Part B -- Good that the flyer will be distributed with hospital satisfaction
surveys. That should improve the quality of the convenience sample. Eventually, once the final
project is under way, I hope that the questionnaire itself will be distributed with the patient
satisfaction surveys.
Conclusion
Often, public policy personnel and medical economists assume that health care is a free market
commodity. In fact, it is not a free market enterprise, but one in which patient choices are extremely
limited. This is especially true for people who live in rural areas where there may be only one
hospital or in regions such as mine where a single hospital system controls nearly half of the
available hospital beds. Choice is also limited by conditions imposed by the medical insurer (HMOs,
networks, etc.). Hospital choice limitations can happen even in a large urban community like NYC
if one requires an ambulance and the EMTs have to take the patient to the nearest hospital. That
"nearest hospital" may have a poorer record for outcomes for that patient's illness than a hospital
only a mile away from the EMT's choice.
It is a matter of life and death to collect as much patient safety information as possible from as many
sources that researchers can reach to challenge deficient hospitals to improve and to inform the
public so that families can protect their loved ones from providers whose outcomes are below those
achieved by other providers within their locality.
The AHRQ proposed research promises to aid both hospitals and the public in significantly
improved patient safety, but only if the research is conducted in a rigorous manner so that the reports
elicited have statistical weight, and only if the results are made accessible to the public. Currently
collected patient satisfaction surveys provide an important model both for collection methods and
public accessibility through Hospital Compare.
Again, thank you for the opportunity to comment on this important and promising project. It is long
overdue.
Martha Deed, PhD
Psychologist (Ret) and Patient Safety Advocate
Submitted via E-mail, October 1, 2012
-The Last Collaboration
http://www.amazon.com
Read online
http://www.furtherfield.org/friendsofspork/
Intro by Edward Picot
http://www.furtherfield.org/features/articles/last-collaboration
City Bird: Selected Poems (1991-2009) by Millie Niss, edited by Martha Deed
http://blazevox.org/index.php/Shop/

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Medical Patient harm
Monday, October 01, 2012 8:53:54 AM

Just file this with the other comments
From: [email protected] [mailto:[email protected]]
Sent: Monday, October 01, 2012 3:17 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Re: Medical Patient harm

Dear, Ms. Lefkowitz,
Thank you for the update. I do hope the VA is not overlooked. The way the system is set up it
is self regulating, and protecting which is never beneficial to patients rights.
Regards
George Mc Grath
From: "Lefkowitz, Doris C. (AHRQ)"
To: "[email protected]"
Sent: Wednesday, September 26, 2012 10:20 AM
Subject: RE: Medical Patient harm
Dear Mr. McGrath,
As of this time the specific hospitals to be included in the pretest of the patient safety program have
not been determined, but VA hospitals have not been excluded.
Sincerely,
Doris Lefkowitz
Reports Clearance Officer
From: [email protected] [[email protected]]
Sent: Wednesday, September 26, 2012 12:44 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Medical Patient harm

I am a United States disabled veteran who has suffered harm by Doctors in the VA system,
and as you may know we have no Constitutional rights to protect us. Would the VA also be
required to report any patient harm under any proposed patient safety program being
considered?
I thought it important to ask this question and would appreciate a reply.
Regards
George Mc Grath
[email protected]
702-736-1240

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Medical error reporting
Friday, September 28, 2012 8:56:48 AM

-----Original Message----From: Harold [mailto:[email protected]]
Sent: Thursday, September 27, 2012 9:00 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Medical error reporting
Dear Ms Lefkowitz,
I would like to share my view on medical error reporting.
I very much believe that errors need to be reported from all medical
providers. Too many people come out of medical care injured or in worse
condition than when they went in for treatment. This is necessary in
both hospitals and private practice.
There are some elements which need to be included in any system.
The practitioner (or someone responsible for them) must be able to
respond with comments about the incident. If such comments are to be
allowed, and if any of them are reviewed by an independent expert, the
determination of that expert needs to be attached to the incident case
transcription. The response process should include a right for the
provider at fault to ask for a formal review and have that information
included in the visible database.
It is also essential that this information be available to the
population. Previous attempts to provide intelligent feedback on
physicians has been fought with great vigor and significant success.
There needs to be more tools for a person to knowledgeably select care
givers. Both individual providers and institutions and businesses.
Given that some studies determined error rates at odds with reported
errors using treatment codes in hospital records, I have to wonder if
insurance claims would contain the necessary information to do the same
analysis. A simple program, but a lot of computer power, could extract
and summarize this information. Likewise insurance companies and the VA.
Respectfully,
Harold Harrington

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: centralized reporting system
Friday, September 28, 2012 8:56:06 AM

From: Kathy Grover [mailto:[email protected]]
Sent: Friday, September 28, 2012 2:20 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: centralized reporting system

We are in desperate need of a centralized reporting system for medical errors and a few other
things too, such as a good centralized way to report drug size effects that doctors ignore. But
right now, just addressing the issue of a centralized reporting system for medical errors -- we
need that pronto.

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Patients reporting medical errors
Thursday, September 27, 2012 11:06:12 AM

We can just file this one too
From: Beverly Botchlet [mailto:[email protected]]
Sent: Thursday, September 27, 2012 11:04 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Patients reporting medical errors

Doris,
I recently read the article on ProPublica.org regarding the issue of patients reporting medical
errors, or better yet, not reporting medical errors. I appreciate the offer in this article to email you
comments. So thank you for that.
For the last 29 years I have been a Legal Nurse Consultant. I review medical records for actual or
potential medical malpractice or nursing negligence legal cases. So I know the ultimate end of the
spectrum of disgruntled patients or families of patients. When a patient becomes the victim of
wrongdoing within the healthcare system, they want/need a recourse. It appears to me that the
legal system is the last, or rather should be the last, resort. But it often times is the first and
sometimes the only recourse.
There has to be a system in place that is an avenue for these people to contact BEFORE or instead
of seeking legal counsel. There are a variety of scenarios we could talk about all the way from not
being treated kindly to actual injury or even death. But at some point, any wronged person will
start to feel they need answers and some will feel they need justification. An avenue, a system or
whatever you want to call it, could be a possible answer or outlet. Short of either having that
person be resentful for the rest of their lives or for them to turn to the legal system, there needs to
be a patient advocate group available to them from within the healthcare facility where they
experienced an untoward event. Every healthcare institution should feel this as an obligation.
Healthcare facilities can and ethically should offer a way that the patient or patient’s family feels is
an approachable way to begin their catharsis. That just seems reasonable. And one of the possible
outcomes could be a decrease in the number of lawsuits we see filed each year.
Thanks again for this opportunity.
Respectfully,
Beverly Botchlet, RN, MS
Discovery, Inc.
16116 Pointe Oak Circle
Edmond, OK 73013
405-285-9474

[email protected]

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: comment on AHRQ for reporting adverse reactions
Thursday, September 27, 2012 9:35:26 AM

From: [email protected] [mailto:[email protected]]
Sent: Thursday, September 27, 2012 7:04 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: comment on AHRQ for reporting adverse reactions
Dear Ms Lefkoitz, HHS,
Regarding the proposal for AHRQ to handle the reporting of adverse reactions from the public, I am
concerned that it would take valuable information away from MedWatch. The MedWatch phone number
for adverse reaction reporting is mandated to be supplied to the consumer by the pharmacy with every
new prescription, so an additional reporting group will be confusing to the consumer. There should be
just one group for collected adverse reaction information; fractionated collection of adverse reaction
data for study does not serve public safety in the goal of practicing Evidence-based medicine.
Sincerely,
Katherine Suskevich RPh
2213 Edgar Rd
Point Pleasant NJ 08742

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Why patients don"t report medical errors
Thursday, September 27, 2012 9:35:00 AM

From: Mary Spelmanis [mailto:[email protected]]
Sent: Thursday, September 27, 2012 9:26 AM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Why patients don't report medical errors

v
v

If they are in a facility, they are afraid they will be retaliated against and their care will be
compromised or they will be deliberately harmed.
Once they are past the event, they either are too busy dealing with the medical
consequences or just want to move on with their lives.

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From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comment period
Wednesday, September 26, 2012 5:06:32 PM

From: Borders, Ann [[email protected]]
Sent: Wednesday, September 26, 2012 5:05 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comment period

I fully support the concept of patient reporting to a central agency on patient harm. I am
wondering if behavioral health will be included. I would recommend it. Thank you.
Ann Borders
President and CEO
Cummins Behavioral Health Systems, Inc.
5101 East US 36, Suite 101
Avon, IN 46123
Phone 317-745-9564
FAX 317-745-9569

The information in this e-mail and any attachments may contain protected health information as defined by HIPAA, state and
federal confidentiality rules (42CFR Part 2) and I.C. §16-39-2-5. It is intended only for the use of the individual(s) or entity name
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From:
To:
Subject:
Date:
Importance:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Patient Harm Information
Wednesday, September 26, 2012 3:39:16 PM
High

From: Betty Hebert [[email protected]]
Sent: Wednesday, September 26, 2012 3:14 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Patient Harm Information

1.
2.
3.
4.
5.

should
should
should
should
patient

be gathered in standardized way
be administered by entity other than medical provider or insurance co.
be made public
be user friendly
must be exempt from legal retaliation

Betty Hebert, CRP
Director
Business Development and Relocation

Coldwell Banker ONE
5025 Bluebonnet Blvd
Baton Rouge, LA 70809
USA
Office: 225-925-2500
Fax: 225-925-1119
[email protected]
CELL: 225-788-4232

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: reporting medical mishaps
Wednesday, September 26, 2012 2:49:11 PM

From: Lollis, Kathleen [[email protected]]
Sent: Wednesday, September 26, 2012 1:59 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: reporting medical mishaps

I think there should be a standardized survey with routine questions. But I also think
there should be a space for detailed explanations of complaints or even “kudos”. I
think a lot of patients are concerned about repercussions in their care with said
physician or facility.
I previously worked in a physicians office for 12 years, and I would welcome criticism
as a way to improve our services, and to be patient & family informative and friendly.
In today’s society though with the “I can sue you for whatever” attitude, I can
understand the medical field and the patient concern about having complaints filed or
filing the complaints. Surely there must be a way to have the survey completed with
truthful facts, yet protect those complaining as well as correcting the complaints.

Kathy Lollis
Property Tax Specialist
Greenville County Real Property Services
Business Registration
301 University Ridge, Suite 1000
Greenville, SC 29601
(864) 467-7313 phone
(864) 467-7440 fax
Email: [email protected]
Don't put your thoughts toward what might have been, put your energy into what is
possible.

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which is legally privileged or otherwise exempt from disclosure. They are intended solely for the use of the individual
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From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: medical harm survey
Wednesday, September 26, 2012 2:48:45 PM

From: Cartwright-Kerns [[email protected]]
Sent: Wednesday, September 26, 2012 2:26 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: medical harm survey
Hello
I really don't see what a survey of medical harm is going to do for the patient. If the patient is severely
affected they cannot fill out this form. Family members are likely to be too traumatized to think straight
and fill out the survey. What about repercussions from the hospital or it's staff? The first thought would
be that the patient is a troublemaker. The next step for them is easy: tell the patient that there is
nothing more to do for them and discharge them. This way they can hope that the patient dies or push
the problem off onto someone else.
What about something with teeth? Give the patient and family hope that something like this will not
happen to another person. Please don't ask me to fill out a form at a time when I may no longer be
able to hold a pencil.
Marilyn Kerns
[email protected]

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comments about Developing a Harm Reporting System
Wednesday, September 26, 2012 2:48:22 PM

From: Mary Kleinman [[email protected]]
Sent: Wednesday, September 26, 2012 2:14 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comments about Developing a Harm Reporting System
Dear Ms. Lefkowitz,
I read about the plan to develop a harm reporting system in an NBC article online. I am a doctoral student at Loyola University Chicago,
with a focus on medical sociology. My comments are based on observations and analysis of the care my father received while in a
nursing home in Ohio, as well as other care he and my mother received over the years. I believe that there are many barriers to
reporting errors, which a standardized reporting system might begin to address. In addition to developing a system of patient reporting,
I would urge you to include input from family members.
Different types of assessment tools or systems would need to be developed for patients undergoing care for acute problems, chronic
problems, and those who are institutionalized. On a basic level, patients and relevant family members could be asked to check off on a
list if their encounters with different providers (physician, nurse, aid, other personnel) resulted in harm, as well as if the encounters
resulted in distress. The reason to ask about distress is that while there might have been actual harm, the patient/family might not
understand the specific nature of the harm and thus be unable to articulate it. There could also be space for additional comments. This
basic type of survey could be repeated periodically for those who are institutionalized. As data were obtained from an initial reporting
system, additional reporting measures could be implemented in the future. The system could be piloted on a small scale, refined, and
then implemented more broadly.
Individuals who are in nursing homes or institutionalized in another type of health facility are the most likely to be subject to medical
errors just because they have more encounters with healthcare personnel. I will provide one example of a medical error experienced by
my father, and discuss why this was not reported. In approximately April 2011, one of my family members inadvertently learned that my
father's roommate in the nursing home had C-diff. My father recently had oral surgery, and was immuno-compromised. I did a little
research about this disease, and spoke with the director of nursing about my concerns, not only for my father's health, but also for the
welfare of their staff and other residents. The director of nursing was dismissive of my concerns. I then researched the approach taken
by other healthcare organizations in the area (e.g. The Cleveland Clinic) to C-diff patients, and learned that they isolated such patients.
I also reviewed the Ohio Department of Public Health recommendations, and it seemed that while isolation was not mandated, it was
strongly recommended because it was the prudent course of action. In subsequent discussions with the nursing director, she did not
appear to understand the airborne nature of C-diff, and that normal antiseptic procedures were inadequate. I finally requested that my
father be moved from that room, and he was. After my father was moved, other nursing staff told him that C-diff was not harmful,
which I know to be false. I truly believe that there was a general lack of understanding about C-diff in this particular nursing home,
resulting in care that could potentially cause a great deal of harm.
I did not report this incident for a number of reasons. I was not sure if this was a reportable offense. I did not know to whom it could
be reported. Even if I could have reported it, I would have been concerned about possible retaliatory actions toward my father. His stay
at this nursing home was covered by Medicaid and his Social Security, so there were not other realistic options for placement at another
facility. Thus, he was dependent on his caretakers at this facility. He was not able to report this himself because he had a language
barrier.
Given the extent to which patients and families depend on specific healthcare providers (especially in smaller communities), and given
that there may be personal relationships with these individuals, it makes the reporting of errors challenging and less likely. However, it
seems that at a minimum, when state or federal funds are used to pay for care, it is reasonable to expect some level of monitoring of the
quality of care. A harm reporting system will create mountains of data, and as the system is developed, consideration must also be given
to the structuring, storage, and analysis of this data, as well as what actions will be taken in cases of egregious or ongoing errors.
Thank you for the opportunity to provide my initial thoughts about the proposed project.
Regards,
Mary Kleinman

Mary Kleinman, MA
Loyola University Chicago
Center for Urban Research and Learning
6430 N. Kenmore Ave.
Chicago, IL 60626
(773) 508-8556
(773) 508-8510 (Fax)

From:
To:
Subject:
Date:

Lefkowitz, Doris C. (AHRQ)
Roemer, Marc I. (AHRQ)
FW: Comments about Developing a Harm Reporting System
Wednesday, September 26, 2012 2:48:22 PM

From: Mary Kleinman [[email protected]]
Sent: Wednesday, September 26, 2012 2:14 PM
To: Lefkowitz, Doris C. (AHRQ)
Subject: Comments about Developing a Harm Reporting System
Dear Ms. Lefkowitz,
I read about the plan to develop a harm reporting system in an NBC article online. I am a doctoral student at Loyola University Chicago,
with a focus on medical sociology. My comments are based on observations and analysis of the care my father received while in a
nursing home in Ohio, as well as other care he and my mother received over the years. I believe that there are many barriers to
reporting errors, which a standardized reporting system might begin to address. In addition to developing a system of patient reporting,
I would urge you to include input from family members.
Different types of assessment tools or systems would need to be developed for patients undergoing care for acute problems, chronic
problems, and those who are institutionalized. On a basic level, patients and relevant family members could be asked to check off on a
list if their encounters with different providers (physician, nurse, aid, other personnel) resulted in harm, as well as if the encounters
resulted in distress. The reason to ask about distress is that while there might have been actual harm, the patient/family might not
understand the specific nature of the harm and thus be unable to articulate it. There could also be space for additional comments. This
basic type of survey could be repeated periodically for those who are institutionalized. As data were obtained from an initial reporting
system, additional reporting measures could be implemented in the future. The system could be piloted on a small scale, refined, and
then implemented more broadly.
Individuals who are in nursing homes or institutionalized in another type of health facility are the most likely to be subject to medical
errors just because they have more encounters with healthcare personnel. I will provide one example of a medical error experienced by
my father, and discuss why this was not reported. In approximately April 2011, one of my family members inadvertently learned that my
father's roommate in the nursing home had C-diff. My father recently had oral surgery, and was immuno-compromised. I did a little
research about this disease, and spoke with the director of nursing about my concerns, not only for my father's health, but also for the
welfare of their staff and other residents. The director of nursing was dismissive of my concerns. I then researched the approach taken
by other healthcare organizations in the area (e.g. The Cleveland Clinic) to C-diff patients, and learned that they isolated such patients.
I also reviewed the Ohio Department of Public Health recommendations, and it seemed that while isolation was not mandated, it was
strongly recommended because it was the prudent course of action. In subsequent discussions with the nursing director, she did not
appear to understand the airborne nature of C-diff, and that normal antiseptic procedures were inadequate. I finally requested that my
father be moved from that room, and he was. After my father was moved, other nursing staff told him that C-diff was not harmful,
which I know to be false. I truly believe that there was a general lack of understanding about C-diff in this particular nursing home,
resulting in care that could potentially cause a great deal of harm.
I did not report this incident for a number of reasons. I was not sure if this was a reportable offense. I did not know to whom it could
be reported. Even if I could have reported it, I would have been concerned about possible retaliatory actions toward my father. His stay
at this nursing home was covered by Medicaid and his Social Security, so there were not other realistic options for placement at another
facility. Thus, he was dependent on his caretakers at this facility. He was not able to report this himself because he had a language
barrier.
Given the extent to which patients and families depend on specific healthcare providers (especially in smaller communities), and given
that there may be personal relationships with these individuals, it makes the reporting of errors challenging and less likely. However, it
seems that at a minimum, when state or federal funds are used to pay for care, it is reasonable to expect some level of monitoring of the
quality of care. A harm reporting system will create mountains of data, and as the system is developed, consideration must also be given
to the structuring, storage, and analysis of this data, as well as what actions will be taken in cases of egregious or ongoing errors.
Thank you for the opportunity to provide my initial thoughts about the proposed project.
Regards,
Mary Kleinman

Mary Kleinman, MA
Loyola University Chicago
Center for Urban Research and Learning
6430 N. Kenmore Ave.
Chicago, IL 60626
(773) 508-8556
(773) 508-8510 (Fax)