nesthesiologists
and hospitals are about to be released from the
burden of ensuring that medications are locked
up in between cases in the operating room.
On March 25, 2005, CMS announced in the Federal
Register that it proposed to change the regulation
that surveyors have been interpreting as requiring
anesthesia carts to be either locked or under
constant surveillance at all times, in the operating
suite or elsewhere.
Hospital Conditions
of Participation — Pharmaceutical
Services
42 C.F.R. § 482.25(3)(b)(2)
Current regulation
Drugs and biologicals shall be kept
in a locked storage area.
Proposed regulation
(i) All drugs and biologicals must
be kept in a secure area, and locked when
appropriate.
(ii) Drugs listed in Schedules II, III,
IV, and V of the Comprehensive Drug Abuse
Prevention and Control Act
of 1970 must be kept locked within a secure
area.
(iii) Only authorized personnel may have
access to locked areas.
|
Thus we enter the final phase of the campaign
to persuade CMS to conform its policy to our own.
In October 2003, the ASA Executive Committee considered
the threat to patient safety if such drugs as
epinephrine were inaccessible at critical moments.
This threat came from a growing number of hospital
surveyors — and mock surveyors — applying
a narrow interpretation of the regulation. The
Executive Committee approved a Position Statement
titled “Security of Medications in the Operating
Room” <www.ASAhq.org/Washington/LockedCartPolicyFinalOct2003.pdf>
that was consistent with the policy adopted by
the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO).
According to the ASA Position Statement, “Because
the operating room is a limited-access secure
location, it is safe practice for anesthesia professionals
to leave non-controlled medications on the top
of their anesthesia carts or anesthesia machines
for brief periods (e.g., while going to a nearby
holding area to bring a patient into the operating
room).” The Statement also recommends that
access to the O.R. suite be strictly limited to
authorized persons. It reflects an explicit choice
in balancing the need to prevent tampering or
diversion of medications against the possibility
that an anesthesiologist transporting a patient
to the recovery area may need immediate access
to drugs required for emergency patient care and
that locking up such drugs could constitute a
threat to life.
CMS cited our Position Statement in coming to
its conclusion that:
This discussion in the
Federal
Register notice confirms the persuasive nature
of the information given to CMS staff in a February
2004 visit to Baltimore by then President-Elect
Eugene P. Sinclair, M.D., then First Vice-President
Orin F. Guidry, M.D., and Section on Professional
Standards Chair Jerry A. Cohen, M.D. For a description
of that visit, please see the April 2004
ASA
NEWSLETTER. Although we have waited longer
than expected for the change to be announced, CMS’
decision to issue a new regulation and not just
to rewrite the Interpretive Guidelines for its surveyors
will better protect the new governmental policy.
Note that CMS has published a notice of a
proposal
only. The Agency will receive public comments
through May 24, 2005. ASA will file an official
comment letter, and we strongly encourage ASA members
individually to write to CMS in support of the change.
It is quite possible that certain equipment manufacturers
that have invested in marketing locking devices
for anesthesia carts will oppose the change. Instructions
for filing comments — on the liberalization
of the rules on who may sign the postanesthesia
follow-up
report
described in the March 2005 issue of the NEWSLETTER
as well as on the locked carts matter — are
in the Federal Register notice that may be downloaded
from the address listed under Source Materials.
Please send a copy of your letter to
<k.bierstein@asawash.org>.
We would also recommend that you give your hospital
administration a copy of the CMS Press Release and/or
of the
Federal Register Notice if there
are any concerns about CMS or JCAHO requirements
regarding medication security.
ASA
Information Technology Expert Becomes a Resource
to CMS
eith Ruskin, M.D., Chair of the ASA Committee on
Electronic Media and Information Technology, is
the author of a report on the interoperability of
electronic health records that CMS has asked him
to make available so that its staff will have access
to “the best thinking about health information
technology.” ASA is pleased to place Dr. Ruskin’s
report on our Web site at
<http://www.asahq.org/news/NHINRFIResponse.pdf>
for the benefit of members as well as CMS.
This exchange resulted from a “Request for
Information” published in the
Federal
Register by CMS in November 2004. Dr. Ruskin,
who also serves on the American National Standards
Institute subcommittee that develops the standards
for electronic claims processing mandated by the
Health Insurance Portability and Accountability
Act, was an obvious choice to provide expert advice
from an anesthesiology point of view.
The value of electronic health records in increasing
patient safety is evident. In a 60-cardiologist
practice in the Midwest, for example, the physician
director of medical informatics has shown that integrating
performance measures developed by the Physician
Consortium for Performance Improvement into his
practice improved patient care and saved money by
avoiding hospitalizations. Specifically, after one
year of integrating the consortium’s coronary
artery disease measures into its practice, the cardiology
group was able to report 78 fewer deaths among its
2,368 patients — 158 fewer heart attacks,
38 fewer strokes and $3 million to $5 million saved
in hospitalizations, compared with results for similar
patients in published studies.
Many anesthesiologists and other physicians are
concerned with the costs of implementing and using
electronic medical records and with potential additional
documentation burdens. The money saved by avoiding
hospitalizations may not directly benefit physicians,
unless perhaps they are part of a health system.
The Physician Consortium (on which Ronald F. Gabel,
M.D., represents ASA) is well aware of the need
to make performance data entry automatic, i.e.,
a “byproduct of care” that will allow
doctors to become “information analyzers”
rather than data collectors.