February 2007
Volume 71 |
Number 2 |
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Anesthesia Carts: New Federal
Regulation Aligns With ASA Policy
Karin Bierstein,
J.D., M.P.H.
Associate Director of Professional Affairs
  This
article is available in PDF format.
any ASA members have struggled to comply with
the hospital requirement that anesthesia carts
be locked between cases. Over the last several
years, surveyors from the Joint Commission and
from state health agencies have surprised quite
a few departments by insisting on an extremely
strict interpretation of the old Medicare regulation
that provided, “Drugs and biologicals shall
be kept in a locked storage area” (Conditions
of Participation, 42 C.F.R. §462.25(b)).
As a result of a lengthy ASA campaign to change
the so-called “locked cart rule,”
the Centers for Medicare & Medicaid Services
(CMS) revised the regulation effective January
26, 2007. The regulation now states that “All
drugs and biologicals must be kept in a secure
area, and locked when appropriate.”
It was the intention of CMS to give hospitals
more flexibility in their policies on the storage
of noncontrolled substances. Drug Enforcement
Administration (DEA) Schedule II, III, IV and
V drugs must continue to be kept locked even within
a “secure area” such as an operating
room (O.R.) suite. (Schedule V drugs are not used
in anesthesia practice.) Only authorized personnel
may have access to locked areas. As long as nonscheduled
medications are in a “secure area”
with access limited to authorized personnel, patients
and supervised visitors, they do not need to be
locked up in addition. Thus to cite the most obvious
example, in an active O.R. suite it is not necessary
to lock the anesthesia cart while the anesthesiologist
is taking the patient to the recovery area.
In explaining its rationale for modifying the
locked carts rule, CMS cited the Position Statement
on Medication Security approved by ASA’s
Executive Committee in October 2003, agreeing
that it is critical for anesthesiologists to have
access to resuscitation drugs and also acknowledging
the need to set up anesthesia carts in preparation
for use in the O.R. or labor and delivery unit.
The position statement provides that “Anesthesia
carts and anesthesia machines may remain unlocked,
and non-controlled … medications may be
left in or on top of unlocked anesthesia carts
or anesthesia machines immediately prior to, during,
and immediately following surgical cases in an
operating room, so long as there are authorized
operating room personnel in the O.R. suite.”
ASA members should consult the Position Statement
on Medication Security, which is available at
www.ASAhq.org/clinical/LockedCartPolicyFinalOct2003.pdf,
in assisting their hospitals to update their own
medication security policies.
Sample Policy Language
In the discussion accompanying the Federal
Register notice regarding the revision to
the regulation, CMS emphasized flexibility in
allowing hospitals to determine their own medication
security and storage policies. Thus there are
several approaches, concepts and phrases that
each hospital, in order to comply with the Medicare
Conditions of Participation (CoP), must define
in its own policies, including “secure area”
and “authorized personnel.”
This particular CoP on “Pharmaceutical Services”
imposes primary responsibility for local policies
on hospital pharmacy units, but complementary
policies also may be developed by anesthesiology,
nursing, facilities and other hospital services.
It is clear that they must be consistent with
each other as well as with state and local law.
In
order to help anesthesiologists work with their
hospitals to update applicable policies, we offer
sample language in Figure 1.
James S. Hicks, M.D., Chair, Peter J. Dunbar,
M.D., and Mark Singleton, M.D., of the Committee
on Quality Management and Departmental Administration,
contributed their time and expertise to the creation
of this basic sample policy, which readers will
need to customize. The sample policy assumes a
teaching hospital in which access is generally
restricted only to the O.R. suites and to some
of the nonsurgical procedure units. The major
items for customization include enumeration of
controlled substances, determination of “secure
areas” within the hospital, identification
of procedures for controlling entrances to the
secure areas, identification of the type of locking
mechanism used (e.g., automated dispensing machines)
and definition of “authorized personnel.”
The quid pro quo for the flexibility that CMS
is giving hospitals in determining how to secure
medications is its expectation that hospitals
will monitor the effectiveness of their policies
and procedures. If tampering or diversion occur,
hospitals should reassess and modify their solutions.
Impact on JCAHO Surveys
The federal standard now requires that medications
be locked “when appropriate,” i.e.,
when they are on Schedules II, III, IV or V and
when they are not otherwise in a “secure
area.” What does this mean if a Joint Commision
surveyor visiting your O.R. still insists that
an unlocked anesthesia cart merits a citation?
The Joint Commision’s role is to ensure
that accredited hospitals are in compliance with
the Medicare CoPs. The Joint Commision may impose
stricter standards than does Medicare, but there
is no applicable Medication Management (MM) standard
that stipulates locked anesthesia carts. The relevant
standard (MM.2.20) provides only that “Medications
are properly and safely stored,” and the
closest Element of Performance (EP.5) prohibits
“Unauthorized persons, in accordance with
the hospital’s policy and law or regulation
[from obtaining] access to medications.”
Emergency medications must be “stored in
sealed or in locked containers; in a locked room;
or under constant supervision in accordance with
law or regulation” (MM.2.30, EP.6). Storage
in a “secure area” as defined in the
new regulation would satisfy the requirement of
“constant supervision” in accordance
with law.
To mitigate any remaining ambiguities or individual
surveyors’ propensity to continue demanding
locked anesthesia carts, ASA’s representatives
have asked the Joint Commision to issue clarifying
language. If a surveyor contends that the Interpretive
Guidelines issued by CMS’ Division of Survey
and Certification require that noncontrolled medications
on anesthesia carts be locked up, you should respond
that the Interpretive Guidelines mandate storage
in a secure area, not a “locked storage
area.” To the extent that the old language
about “monitoring” the anesthesia
cart appears to mean that a clinician must be
in the room any time when the cart is left unlocked,
that interpretation has been superseded by the
new regulation and will be revised. If necessary,
request a reconsideration or even an appeal to
the Medicare Regional Office.
Thus should end the controversies surrounding
the implementation of procedures to secure anesthesia
medication in a manner consistent with the law.
ASA leadership can now focus its attention on
genuine medication-related threats to patient
safety, such as incorrect drug labeling.
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Karin
Bierstein, J.D., M.P.H., advises ASA officers,
committees and members on health policy and
practice management strategies. |
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