For all Massachusetts health care consumers: Testimony on the new Chapter 305 law

This was our testimony of Health Care for All's Consumer Health Quality Council before the Public Health Council, presented by Linda Burgess, Nicola Truppin, Deb Wachenheim and me:


RE: 105 CMR 130.000, Hospital Licensure, and 105 CMR 140.000, Licensure
of Clinics

Thank you for the opportunity to provide testimony on the regulations for
implementing sections of Chapter 305, the landmark cost containment and
quality improvement law. Health Care For All and the Consumer Health Quality
Council advocated for this law, and for these measures in particular, and we are
pleased to see steps being taken toward implementation.

The Consumer Health Quality Council is a coalition of Health Care For All. The
Consumer Council brings together Massachusetts residents who have been
impacted by poor quality health care and who are motivated by those
experiences to advocate for health care quality improvement. The members of
the Consumer Council want to work to ensure that what happened to them and
their families will not happen to someone else. The Consumer Council believes
that Chapter 305 will advance patient safety and health care quality for all
Massachusetts health care consumers.

Reporting of Serious Reportable Events and Infections
Many of our comments for both of these reports are similar, so you will see below
comments that apply to both reports and a few comments particular to one report
or the other.

Serious Reportable Events (SREs) are also known as "never events" because
these are events that should never happen in a health care setting. These
include events such as wrong-site surgery and wrong person surgery as well as
very serious medication errors and serious pressure ulcers. All together, there
are 28 events on the SRE list that has been established by the National Quality
Forum. While we all hope that these events are very rare, we know this is not yet
true. We applaud the steps that the Department of Public Health and the Board
of Registration in Medicine have already taken to track and reduce the
occurrence of these events. We believe the public reporting of SREs will not only
educate consumers about the fact that these events do happen and where they
are happening but will also prod hospitals to put in place preventative-based
systemic changes in order to reduce the likelihood of occurrence. We know that
the first hospital-specific report is due to come out in April 2009 and we plan to
do our part to educate the public about the report and how the information can be
appropriately used.

We also applaud the infection prevention, reduction and reporting work that has
been under way for some time under the direction of DPH and the Betsy Lehman
Center. A number of the Consumer Council members have been profoundly
affected by hospital-acquired infections and we look forward to seeing the first
public report on infections which will be released in April 2009, with the first
hospital-specific report coming out in the fall. We believe that these reports will
also both educate consumers and encourage improvement within hospitals.
Much needs to be done to prevent infections. Some practices such as hand-
washing are highly effective and inexpensive. And when compared to the cost of
treating or managing an infected person, prevention is inexpensive. We are
confident that public reporting will move hospitals and our health care delivery
system in the right direction. We hope to eventually see the SRE and infection
reports extended beyond the hospital and ambulatory surgery center settings to
include, for example, nursing homes.

Comments pertaining to reporting of SREs and infections:
According to Chapter 305, both public reports will be available on the website of
the Quality and Cost Council (QCC). The Consumer Health Quality Council is
available to serve as a consumer focus group as the website pages with these
reports are developed. We encourage the QCC, DPH, and EOHHS to undertake
a publicity campaign, which could include, for example, web postings and radio
and television public service announcements, to ensure that consumers are
aware of the existence of the reports and how they can access and use them.

• The reports should be easy to find, with a clear link from the homepage of
the Department of Public Health, the homepage of the QCC website, and
others.
• Reports should be available in languages other than English and
understandable to individuals with varying levels of health literacy.
• Reports should clearly illustrate the number of incidents and the health
care facilities’ responses to them. We would like to see the actual reports
include not just the numbers of SREs and infections that occurred at a
given hospital in a given year but to also show trend numbers over the
years for each hospital and to provide some information on improvement
efforts that hospitals have undertaken to reduce the SRE and infection
rates.
• Information should be available to consumers via the Internet but there
should also be other methods for accessing this information, for example:
o 1-800 phone number which consumers can call to find out
information about given hospitals;
o Require hospitals and clinics to have paper copies of the reports
on-site and/or to have computers which consumers can use to view
the websites.
• Public reports should be timely and not out of date, so that the information
is most useful to consumers and most accurately represents a hospital's
current standing.
• Reports should point out hospitals that report no incidents, or very few
SREs and/or infections. We are concerned that there may be
underreporting, especially initially, and we want oversight entities to be
aware of cases in which further investigation may be needed to ensure
that hospitals are complying with the law.
• The types of reportable SREs and infections should be regularly reviewed
by a task force to determine if the list of reportable events should be
expanded and/or revised. There should be at least one consumer
representative on any task force charged with this periodic review

Comments specific to the SRE reports:
In addition to reporting on the number and types of SREs that occur at each
hospital, we believe it would be useful for the report to also show the number of
SREs for each hospital for which related care was reimbursed and the number
for which care was not reimbursed under the nonpayment policy that is also in
Chapter 305. That will give the public a better sense of how many of the SREs
were and were not preventable. Finally, we encourage DPH and the Patient Care
Assessment (PCA) Program of the Board of Registration in Medicine to continue
to play an active role in rooting out and investigating SREs.

A comment specific to the infection report:
The initial public report on healthcare-associated infections will only provide
information on three types of infections. We strongly believe that the public
deserves to have access to information about many more infections. We know
that many more infections will be confidentially reported to the Betsy Lehman
Center and internally within hospitals. Some of those infections should be
publicly reported as well. Again, this will both allow consumers to make educated
choices as to where they get their care and drive hospitals even further to reduce
those infections that are publicly reported.

Nonpayment for Serious Reportable Events
The Consumer Council believes strongly that stopping payments for care needed
as a result of a preventable SRE will help to prevent the events from happening.
Medicare and other insurers have started taking steps in this direction, and we
applaud Massachusetts for being the first state to legislate this policy across all
hospitals. As suggested in the public reporting section, we recommend that a
task force be established to periodically review the list of SREs and determine if
the list of those for which care may not be reimbursed should be expanded
beyond the NQF list. This is especially important as Medicare, for example, is no
longer paying for services related to events, such as certain infections, that are
not on the NQF list.

Patient/Family Notification: The Consumer Council is very concerned that there is
no guidance in the proposed regulations regarding how to notify patients/family of
the occurrence of an SRE as well as how to notify about payment policies. It is
left up to each hospital to put together its notification policies and procedures. If
an SRE has occurred, a patient and/or family members may be in the throes of
dealing with the physical and emotional consequences of that event. Or, it is
possible that the patient/family may not be aware that an SRE occurred. Or the
patient could be incompetent and not capable of comprehending the information.
Or English may not be the patient's first language. Obviously much care must be
taken when notification of the SRE is provided.

• In addition to informing the patient/family of the occurrence of the SRE,
they must also be notified of any known risks or future harm that could
result from the SRE.
• Notification should consist of both written and verbal communication and
given in the language of the patient/family to make sure it is understood by
those most impacted.
• We also encourage DPH to require that hospital staff be trained in the best
practices for disclosing such information to patients/family members.
• An independent third party should be present for these disclosures who
can attest to what the hospital disclosed, when and in what manner.

Non-payment: In providing information to patients/family about the decision to bill
or not bill, this must again be in the patient’s language and must be written so
that those with varying levels of health literacy can understand it. Our hope is that
as healthcare facilities become more comfortable disclosing SREs and other
adverse events, there will be improvements in patient/provider communication
over all.

We would like to see DPH play a more active role in helping to determine if an
SRE occurred and if it was preventable, in which case related care should not be
reimbursed. Under the proposed regulations, it seems that the hospitals have
most of the control over determining whether or not to charge. They may have an
appeals process that has been negotiated with the third-party payer, but we
believe DPH should have an active role as well. Further, the consumer should be
able to appeal a decision, especially, but not only, if there is not a third-party
payer or there is a high deductible to be met, and that appeal should involve
DPH.

The proposed regulations require that the hospitals submit a Root Cause
Analysis report to DPH, the payer and the patient if they do decide to charge for
care related to an SRE. However, there is no requirement to do this if they do not
decide to charge. This must be required in both cases, so that patients are fully
informed and so that hospitals learn from their mistakes. DPH should also require
that the SRE is recorded in the patient's medical record.

There needs to also be some guidance regarding the length of time for which
care related to a preventable SRE is not reimbursed. Once the patient leaves the
hospital, there may be a need for follow-up care. The patient should not have to
pay anything for that care, whether or not they go back to the same hospital, and
they should be fully informed that they do not have to pay. And a third-party
payer should not have to pay for any related follow-up care if given by the same
or an affiliated institution.

Finally, once the regulations are finalized and implemented, we believe there
should be a public information campaign to ensure that consumers are aware
that this nonpayment policy is in place and applies across Massachusetts.

Patient and Family Advisory Councils
The Consumer Council is very excited about the requirement for hospitals to
establish Patient and Family Advisory Councils (PFACs). We have seen models
for how these PFACs can be extremely effective and valued entities within an
institution. Hospitals such as Dana Farber have developed PFACs that are called
upon to bring their voices to many different aspects of the institution's work.
Every hospital in Massachusetts should establish these vehicles for bringing the
voices of patients and family members to their work.

We also strongly believe that the minimal cost associated with establishing and
maintaining PFACs is more than made up for with increased levels of patient and
family satisfaction, both in terms of having their voices heard and in terms of
actually making a difference in the quality of care provided. Patients and family
members bring unique perspectives to the work of a hospital and those
perspectives are often not heard unless there is an established mechanism to
ensure they are heard. Health Care For All and the Consumer Council are eager
to play a role in working with patient and family advisors across all
Massachusetts hospitals as the PFACs are established. We want to work to
ensure that the PFACs are effective bodies and are not established without being
nurtured by their institutions.

PFAC Membership: The proposed regulations require that at least 50% of the
membership of a PFAC be made up of patients and family members. While we
are pleased to see the requirement that a majority of the members have the
patient/family link to the hospital, we are a bit concerned that up to 50% of
membership could in theory be made up of hospital staff. We would like to see
some language specifically stating that 50% of the group cannot be staff only.
Perhaps the language could suggest a certain ratio of patients/family members to
staff (for example, 3-4 patients and family members for every one staff person) to
ensure that the group does not become too staff heavy. Further, we would like to
see language stating that there should be at least a minimum number of patients
and family members on each PFAC, to ensure that they are not too small to be
effective. According to the Institute for Family-Centered Care, an ideal minimum
number of patients and family members on a PFAC is 12-15.

We would also like to see guidelines as to the demographics of the PFAC
membership. The PFACs should reflect the diversity of both the hospitals'
patients and the community it serves. We would like to see a requirement that
individuals can access the PFAC directly without having to go through hospital
staff or administration. This would allow patients/family members with concerns
to know they can directly talk to an individual or group that shares the consumer
perspective. We would also like to see a requirement that a hospital staff person
be the coordinator for the PFAC and be the liaison between the PFAC and
hospital administration.

PFAC Activity Publicly Reported: We request a requirement for public reports
about the work of the PFACs. We know that there is a requirement for hospitals
to report to DPH annually on the work of the PFACs but very few members of the
general public seek out DPH reports. We want to ensure that the public is aware
of the existence of the PFACs and of their work. Perhaps DPH could send the
annual reports to local newspapers and/or require hospitals to post them on an
easily accessible section of their websites as well as have them available to
patients/family upon request. Further, we request that DPH issue a report on a
regular basis (perhaps every other year) summarizing the work and
accomplishments of all PFACs across Massachusetts. This would be informative
for consumers and would allow the hospitals and PFACs to learn from one
another.

Implementation: The regulations as written require that the Advisory Councils be
established by September of 2009. If this deadline is extended, then we strongly
encourage DPH to establish benchmarks that hospitals must meet by certain
dates, with the goal of eventually having a full Advisory Council set up and
running effectively by a set date. The Consumer Council and Health Care For All
would be available to participate in discussions on what those benchmarks and
their associated dates should be.

Rapid Response Methods
The Consumer Council believes that the establishment of rapid response
methods that can be activated by patients and family members will provide an
important tool to those individuals who feel that they need immediate assistance
and are not being heard. A number of members of the Consumer Council believe
that they or their family members could have utilized a rapid response method
had it been available when they were receiving care. If patients/family are well-
informed about the criteria for activating the method, we are certain that it will be
a vital tool that will save lives, as has been seen in hospitals that do have this
method in place.

Education: Our comments relate mostly to education regarding the rapid
response method. Patients and family members must be fully informed, upon
admission, of the existence of the rapid response method, criteria for activating it,
and how to activate it. This should be done in the language of the patient/family
and in the most accessible way possible across levels of health literacy. Some
examples of ways to educate them are with posters in their room and showing a
video, in addition to having hospital staff speak to them directly about the
method. Further, hospital staff need to be fully informed not only about the
method and the criteria, but about the fact that patients/family members can
activate the rapid response method and that staff should feel comfortable with
the fact that patients/family can do this. We do not want staff to see this as a
burden placed on them but rather as a potentially life-saving intervention.

Reporting: We would also like to see a reporting requirement so that the
Department of Public Health and the public, as well as the hospitals, can assess
how often the methods are used, if they were activated by patients, family or
staff, and if the activation helped to avert a potential problem. This reporting will
allow learning by everyone involved so that they can work to make these rapid
response methods as successful as possible.

Record Retention
Health Care For All would like to see language in the proposed regulations on
record retention and destruction requiring the health care facility to attempt to
contact a patient before destroying his/her records.

Thank you again for the opportunity to comment on the proposed regulations.
Health Care For All and the Consumer Health Quality Council look forward to
playing an active role in ensuring that implementation of all of these pieces of
Chapter 305 are a success. Please contact Deb Wachenheim, Health Quality
Manager at Health Care For All, at 617-275-2902 with any questions.


Ken Farbstein, President, Consumer Health Quality Council
Deb Wachenheim, Health Quality Manager, Health Care For All

Advice: Help create and shape new laws to improve patient safety.

Read earlier testimony on patient and family councils.