Mark A. Singleton, M.D.

In fall 2000, anesthesiologists practicing in hospitals in California began to hear from their hospital administrations and operating room management staffs that compliance with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) regulations required that anesthesia carts in the operating room (O.R.) be locked between consecutive cases and that medications could not be left out on the top of the cart while the anesthesiologist was not present. While this edict appeared to be widespread, exact citations of specific JCAHO regulations were difficult to pin down.

The reaction of many anesthesiologists ranged from amazed disbelief to moral outrage that our traditional work space, the sanctified altar of our craft and repository of our magic, would dare be encroached upon by mere bureaucrats. Indeed at the heart of our reaction was more than indignation at being micromanaged. Serious potential patient safety concerns are posed by the impediment to immediate access to emergency drugs and equipment when the anesthesia cart is locked as soon as the anesthesiologist and patient leave the O.R. on the way to the recovery unit.

After some investigation into the origins of these new rules, and questions to authoritative respondents at JCAHO, it became clear that the issue arose not from JCAHO surveyors but from those representing the California Department of Health Services (DHS). In fact JCAHO indicated that as long as Drug Enforcement Administration-scheduled drugs were locked and other medications properly labeled, anesthesia carts could remain unlocked between consecutive cases, which was the practice to which most of us adhered.

As anecdotal reports of hospital inspections accumulated, in which California DHS surveyors cited the necessity for locking anesthesia carts when the anesthesiologist was not present, it was obvious that there was no consistent understanding or interpretation of this concept among the surveyors themselves. The California DHS had no written policy on this specific issue to guide them, so individual surveyors were free to make their own interpretations of broad hospitalwide policies regarding the handling of medication in patient care areas, hence the problem.

In an effort to clarify things, the California Society of Anesthesiologists (CSA) contacted one of its own members who served as a senior consultant and surveyor for the California DHS. Although this anesthesiologist clearly understood the patient safety issues of concern and stated for the record that anesthesia carts should be unlocked between cases, this opinion had little effect on the actions of other surveyors unfamiliar with the potential for catastrophic airway or circulatory instability as a patient is emerging from anesthesia. The locked cart problem persisted.

CSA was finally able to resolve this problem through the very effective advocacy efforts of its governmental relations consultant, the Barnaby firm of Sacramento. They were able to convince the chief medical consultant at the California DHS, Anthony Way, M.D., a urologist, that written guidelines were necessary to promote consistent interpretations among surveyors in accordance with the safe practice of anesthesiology. Dr. Way issued an open memorandum in April 2002, addressed to “all general acute care hospitals” on the subject of “security of anesthesia carts.” In it he cited the following statements from the California Code of Regulations, Title 22: “Drugs shall be accessible only to responsible personnel designated by the hospital … [and] All spaces and areas used for the storage for drugs shall be lockable and accessible to authorized personnel only.” In his interpretation, Dr. Way reasoned that “it is critical that the anesthesiologist or anesthetist has access to the anesthesia machine and anesthesia cart, should an emergency occur during transport of his or her patient to the PAR or should an emergency occur elsewhere in the other O.R.s in the surgical area. Therefore, anesthesia carts and anesthetic machines may remain unlocked during and in between consecutive surgical cases in a given operating room, as long as there are surgical service personnel in the immediate vicinity. Some surveyors consider in the immediate vicinity as ‘line of sight’ to the anesthesia cart, although this is not specified in the regulation, nor is it necessary. Nevertheless, the area needs to be maintained secure at all times. The surgical area should be considered a secure area at all times when in use, and hospitals should develop policies and procedures to ensure that these areas are secure with entrance and egress limited to appropriate staff and patients.”

This document was just what we needed, and it has been immeasurably helpful to anesthesiology departments throughout our state. It is posted on the CSA Web site at <www.csahq.org>.

We thought that the locked cart issue had been effectively dealt with and a clear victory for common sense and sound medical judgment achieved. Just this past October, however, in the weeks preceding the ASA 2003 Annual Meeting in San Francisco, there were reports from anesthesiologists in southern California that inspectors were once again insisting that anesthesia carts be locked between cases when the anesthesiologist was out of the room. This time the authority was from the Centers for Medicare & Medicaid Services (CMS), an agency that heretofore had not been heard from on this issue. JCAHO and DHS inspectors, in their role as “deemed” surveyors for CMS, were citing CMS regulations that state “all drugs and biologicals must be kept in a locked storage area.”

Our delegation introduced an “emergency” resolution to the ASA House of Delegates calling for national action directed toward convincing policymakers at CMS that the O.R. is a secure environment within the hospital and that unimpeded access to the contents of the anesthesia cart at all times is critical to patient safety. With widespread support from the House of Delegates, this resolution was referred to ASA leadership for urgent action. Indeed ASA leaders and the Committee on Quality Management and Departmental Administration began working immediately on this issue. Within days after the ASA Annual Meeting, a position statement titled “Security of Medications in the Operating Room” became available on the ASA Web site at <www.ASAhq.org/Washington/LockedCartPolicyFinalOct2003.pdf>. This document clearly states the requirements for security of the O.R. within a health care facility and the absolute need for immediate access to medications and equipment by the anesthesia provider at all times in which patients may be at risk. (I personally distributed this position statement to department heads and administrators at all the facilities where I work, and I urge everyone to do the same.)

More recently, on February 17, 2004, ASA leaders met with CMS officials to discuss medication security and the issue of locked anesthesia carts. CMS officials appeared to appreciate the significant patient safety risks posed by locked anesthesia carts and were receptive to the concept of security being a condition of operating rooms by their very nature because of access restricted only to authorized persons.

It is optimistically expected that, based on this meeting and the ASA Position Statement on Security of Medications in the Operating Room, CMS will issue new “Interpretive Guidelines” for surveyors that will reiterate our own standard practices, ensuring preparedness and patient safety. It is hoped that these new clarifying interpretations from CMS will be released very soon.

Mark A. Singleton, M.D., is Adjunct Associate Professor, Stanford School of Medicine, and is in private practice at Group Anesthesia Services, Inc., San Jose, California.