This is to inform you about the reports of restraint-related hospital
deaths released by the Health Care Financing Administration (HCFA) to a
number of P&As around the country, and to request that you supply us
with information regarding your follow up activities in connection with
these and future reports.
We
need your assistance in tracking these reports to ensure that they are
meaningful and timely. We also need to learn about your actions taken in
response to these reports - so that we can share this information with
the network generally and with policy makers, who are seeking accountability
in this area. As you know, appropriations increases for this year for PAIMI
($2 million) and PADD ($1.5 million) were provided specifically to support
P&A investigations related to restraint-related deaths. Also, we want
to know if your agency needs any additional resources or other support
to effectively address these death reports. We have developed a form to
collect this information (attached).
Release of Reports
On March 23 HCFA's regional offices, in compliance with the agency's
recent regulations on patient protections in hospitals, released to P&As
reports received from hospitals of patient deaths related to restraint
and seclusion. There was a total
of 20 deaths reported to HCFA and P&As nationwide - for the period
August 2, 1999 (when the regulations became effective) through March 23,
2000. In Florida alone, 7 deaths were reported. Deaths in other
states were reported as follows: CT - 1, NY - 1, NC - 1, OH - 1, LA - 1,
OK - 1, TX - 3, IA - 1, KS - 1, MO - 1 and CA - 1.
Reporting Requirements and HCFA Investigations
HCFA's regulations specify that hospitals must report to HCFA's regional
offices any death that occurs while a patient is in restraint or seclusion,
or where it is reasonable to conclude that the death was related to restraint
or seclusion. (The regulations also set out detailed standards on the use
of restraint and seclusion in hospitals, among other patient protection
requirements.) The reporting requirement applies only to the use of restraints
and seclusion for behavior management, as distinguished from the practice
as applied in connection with acute medical or surgical care. In the guidance
issued with the regulations, HCFA stated that it will share these reports
with P&As.
There is no guidance, however, on the contents of the reports or when
they need be provided. The reports released to date (which have been provided
via phone or fax) contain only the name and address of the hospital, the
name of the patient and the date of the patient's death.
HCFA indicated in the regulations and in a recent meeting that, as result
of these reports, it will conduct on-site investigations of hospitals ("complaint
surveys") in accordance with its current complaint investigation process.
In the future, we will provide more details on this process and how P&As
can coordinate with HCFA on investigations.
Future Reports
With our input, HCFA is developing a reporting protocol to help ensure
that sufficient information is reported to facilitate P&A investigations
of these deaths. In a
recent meeting, HCFA indicated that, in the future, hospital reports of
deaths will be shared with P&As as they are received by HCFA, and hopefully
within a short period after the deaths occur.
P&A Follow Up Activities
There are a number of possible
courses of action that can be taken in response to these death reports:
1. Your agency could conduct
preliminary inquiries and inspect records and facilities based on these
HCFA reports. Given that the death occurred during the course of the hospital's
attempt to manage patient behaviors, it may be concluded that the report
amounts to a "complaint" of potential abuse or neglect - which triggers
P&A access authority under both the DD and PAIMI Acts, and the PAIR
Program, and their implementing regulations. Moreover, the report should
establish a "probable cause" belief that abuse and neglect may have occurred,
which is an independent basis to gain access to records and facilities.
See definitions of these terms at 42 C.F.R. § 51.2 (PAIMI regulations)
and 45 C.F.R. § 1386.19 (DD Act regulations), and Alabama Disabilities
Advocacy Program v. J.S. Tarwater Development Center, 97 F.3d 492 (11th
Cir. 1996) (Alabama P&A's receipt of an anonymous phone message regarding
an institutional death held to amount to a "complaint," and to establish
"probable cause," both authorizing access to records).
2. Your agency could conduct
a full blown investigation, including a thorough on-site inspection of
the hospital and interviews of staff and patients, independent of any HCFA
investigation.
3. Your agency could conduct
an investigation in collaboration with HCFA. Contact should be made with
the HCFA regional office to coordinate.
Recommendation
We strongly recommend that
option 1 be implemented regarding all reports of restraint-related deaths
received to date and in the future. We also recommend that option 2 or
3 be pursued as well. A collaborative investigation with HCFA may be appropriate
if it would not interfere with your agency's independence and ability to
obtain full access to records and facilities and seek appropriate corrective
action in a timely manner.
Network Feedback Needed
We
have developed the attached form to collect information on reports and
follow up activities. We ask that you do the following: (1) If you have
already received one or more HCFA death reports, please fill out the form
and fax it back to NAPAS ASAP; (2) submit a completed form for any
reports received in the future; and (3) provide updated reports on your
activities, as warranted. Any questions regarding this issue may be
directed to Gary Gross.
Information that may be helpful
in responding to these reports - concerning restraint and seclusion policies
(including the HCFA regulations) and P&A access authority - may be
obtained from our website, at: http://www.protectionandadvocacy.com/private/resscfol.htm
and at http://www.protectionandadvocacy.com/private/access.htm.
Thanks for your assistance with this critical initiative.
Fax to Gary Gross, 202-408-9520
RESTRAINT-RELATED HOSPITAL DEATHS REPORTED
BY HCFA: SUMMARY OF P&A
ACTIVITIES
Agency Name: _________________________________________________________________
Contact Person: ________________________________________________________________
Phone and E-mail: ______________________________________________________________
Please provide the information
requested below, and attach additional sheets if necessary. PLEASE SUBMIT
UPDATED FORMS AS ACTIVITIES WARRANT.
1. Report(s)
Received. If a written report of a restraint-related patient death
was provided by HCFA, attach it to this form. If the report was oral, or
additional information not contained in the initial written report was
obtained, describe below the following:
HCFA report attached: Yes ___ No ___
a. Date of report: ___________________
b. Date of patient death: ______________
Also, if known, describe (if information is not available, state "NOT REPORTED"):
c. The circumstances of the
death:
d. Clinical information provided
about the patient:
2. Follow
Up Activities. Indicate the activities your agency has taken or
plans to undertake in response to the report(s):
a. Inquiries and requests
for records and other information (describe information sought and response,
if any):
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
c. Full investigation - in
collaboration with State licensing and certification agency or another
agency (describe method and findings, if any):
d. Other activities (e.g.,
outreach to media):
3. Obstacles
Are there any obstacles preventing
effective follow up of these reports (e.g., insufficient information in
report, denial of access to records, witnesses or facility):
_______________________________________________________________________________________________
4. Assistance
Needed
Is there any assistance needed
to follow up that ATTAC/NAPAS may provide or facilitate:
M
E M O R A N D U M
To: P&A Executive
Directors
This follows up on our memorandum of yesterday regarding the reports
of restraint-related hospital deaths released by the Health Care Financing
Administration (HCFA) to P&As. This memorandum provides information
on how P&As may coordinate with State health care licensing and certification
agencies, which HCFA has authorized to conduct on-site investigations of
hospitals in response to the hospitals' reports submitted to HCFA of restraint-related
deaths.
In our earlier memorandum,
we encouraged P&As to pursue a number of courses of action to follow
up on these death reports. These recommendations include conducting an
investigation in collaboration with HCFA, and making contact with the HCFA
regional office to coordinate.
Based upon discussions with
HCFA today, this statement should be clarified: we now understand that
P&As
should coordinate their investigative activities with their State licensing
and certification agencies (also know as State survey agencies), rather
than with HCFA's regional offices (although the regional offices themselves
oversee the State agencies' activities).
The national office of HCFA
has directed its regional offices to encourage State certification agencies
to coordinate activities with the local P&A. We recommend that P&A
Directors make direct contact with the Directors of these agencies - regarding
death reports already received or which are provided to you in the future
- to enter into a discussion about coordination of investigative activities.
A directory of the State certification agencies may be obtained from the
HCFA website, at http://www.hcfa.gov/medicaid/saddir.htm. The following
discusses how HCFA anticipates these agencies to respond to the death reports,
and suggests approaches for P&A collaboration.
State Licensing and Certification
Activities
State licensing and certification agencies are funded by HCFA to conduct
inspections of health care facilities pursuant to HCFA's standards; the
agencies also apply state law standards, as appropriate. As noted above,
HCFA has authorized these agencies to conduct on-site investigations of
the restraint-related reports of hospital deaths, applying the HCFA regulatory
standards on restraint and seclusion. These investigations may occur in
any one of the nation's 6000 hospitals, including those which are accredited
by the Joint Commission on Accreditation of Health Care Organizations.
The agencies generally will conduct focused investigations of the issues
raised by the reports. However, if they uncover systemic problems, the
investigations (at the direction of HCFA) will be expanded to examine a
large variety of hospital operations. The scope of the investigation will
vary depending on the resources of a particular State agency.
If the hospital is found to have violated HCFA's standards - and according
to HCFA, this is the presumed outcome in the case of a restraint-related
death - the hospital is subject to termination of Medicare and Medicaid
funding. Depending on the severity of violations uncovered, the hospital
is given up to 90 days to demonstrate it has taken appropriate corrective
action to achieve compliance with the standard.
P&A Coordination
As mentioned above, P&A
Directors are encouraged to discuss directly with the local licensing and
certification agency Directors possible avenues to coordinate their investigative
activities.
An initial approach may be to request from the State agency the results
of any investigation already conducted. (HCFA did not know whether any
restraint death investigations had been completed.) Depending on the thoroughness
and findings of the investigation, P&As can focus or streamline their
own investigative activities.
HCFA indicated that the investigation reports of these agencies are
public information (e.g., they may be obtained under the Freedom of Information
Act.) Indeed, such reports also are available to P&As pursuant to their
federal access authority. Under the regulations implementing the PAIMI
and DD Acts, access is authorized to reports of an agency charged with
investigating abuse, neglect or injury, and to supporting information that
was relied upon in creating the reports. Access also is authorized to reports
prepared by entities conducting certification or licensure reviews. See
42 C.F.R. § 51.41 (c)(2) and 45 C.F.R. § 1386.22(b)(2) and (c)(1),
Alternatively, if the State agency has not initiated or completed an
investigation, P&As might inquire about conducting joint investigative
activities or otherwise sharing information.
Please be sure to complete and return the form provided with yesterday's
memo on your activities in this area, and provide information (in sections
2b and c) on coordination with the State agencies.
_____________________________________________________________________________________________
______________________________________________________________________________________________
____________________________________________________________________________________________
b. Full investigation - independent of State licensing and certification
agency (describe method and findings, if any):
____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
______________________________________________________________________________________________
From: Curtis L. Decker, Executive Director
Gary Gross, Senior Public Policy Counsel
Re: Coordination with State Licensing Agencies on Restraint Investigations
Date: March 31, 2000