By James G. Cain, M.D.; Robert F. Early, Jr., M.D.; Donald E. Martin, M.D.; Margaret M. Tarpey, M.D.
Anesthesia Machine Obsolescence
Locked Anesthesia Carts
Deep Sedation by Non-Anesthesiologists
Basic Anesthetic Monitoring
Anesthesia Machine Obsolescence
ASA guidelines have been developed to assist anesthesia providers and other healthcare personnel, administrators and regulatory bodies in determining when an anesthesia machine is obsolete.
Anesthesia equipment can become obsolete if essential components wear out and cannot be replaced. It may also become obsolete as a result of changes in medical practices, changes in the training and experience of anesthesia providers and/or development of new safety features.
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Locked Anesthesia Carts – CMS Rules
By Robert F. Early, Jr., M.D.
EDITOR’S NOTE: This issue has not been resolved as of September 2010, because the Department of Health has been citing several departments as being in violation – despite the fact that those departments have complied with its interpretation of the CMS rule. PSA is currently exploring and addressing this issue.
Considerable confusion exists about how anesthesia personnel should secure anesthesia carts, including medications. The Centers for Medicare & Medicaid Services (CMS) and The Joint Commission requirements only add to the confusion. This uncertainty has occurred because of changes in the standards over time as well as various interpretations of the rules by regulatory agencies.
The American Society of Anesthesiologists (ASA) successfully campaigned to have CMS clarify and modify the locked cart rule. Here is a summary:
- As long as non-scheduled medications are in a “secure area” with access limited to “authorized personnel,” medications do not need to be locked up. However, these medications should be kept in tamper-evident packaging. In an active operating room suite, it is not necessary to lock the anesthesia cart while the anesthesia provider is taking the patient to the Post Anesthesia Care Unit (PACU).
- Hospitals have flexibility to determine their own medication security and storage policies, including the definitions of “secure area” and “authorized personnel.”
- DEA Schedule II, III and IV drugs must continue to be locked – even in a “secure area” – unless the anesthesia provider in physically present.
In an attempt to better understand the ASA’s interpretation of the federal rule, ASA President Roger A. Moore, M.D., wrote a letter to the President of The Joint Commission, Mark R. Chassin, M.D. In the letter, dated Oct. 22, 2008, Dr. Moore states ASA’s position:
“The effect of the new rule is to permit facilities to allow anesthesia carts that contain drugs and biologicals that are not controlled substances to remain unlocked, so long as the carts are kept in a secure area, and locked when appropriate. The rule revision provides needed flexibility, particularly in dealing with emergency situations when quick access to drugs is necessary.” See full letter.
Dr. Moore then asked, “We request that The Joint Commission confirm in writing that, in fact, our understanding of The Joint Commission’s standards vis-à-vis the new CMS rule is correct and that the Commission intends to interpret its standards consistent with our above analysis.”
The Joint Commission responded to Dr. Moore’s letter on Nov. 17, 2008, with the following:
“Your understanding of the CMS regulations in regards to the security of medications as defined in the Federal Registry, published November 27, 2006 and effective January 26, 2007 is correct. The Joint Commission adopted the CMS definition and approach on that date as well and our surveyors were instructed at that time. During the survey process, our surveyors would expect to see your organization’s policy and procedure followed in terms of medication security throughout the organization. Of course, this includes scheduled drugs being appropriately locked as defined by CMS as well.” See full letter.
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By Margaret M. Tarpey, M.D.
Medication administration errors
- Medication administration errors are a rare but serious problem for anesthesiologists
- 1 error for every 133 Anesthetics (0.11 percent-0.75 percent)
- Most common causes:
- 20 percent incorrect doses
- 20 percent incorrect drug during IV boluses
- 69 percent of errors involved drugs of different classes
- 1.2 percent of errors actually caused patient harm
References: Webster: Anaesth Intensive Care 2001; 29:494
Fasting & Grisvold: Can J Anaesth 200; 47:1060
- Of the errors involving administration of the wrong drug:
- 10.8-33 percent are syringe labeling errors
- 18.9-40 percent are syringe swaps
- Drugs most commonly involved – muscle relaxants and opioids
- Major morbidity in 4.7 percent and death in 0.03 percent
- Contributing factors – inattention, haste, fatigue and faulty communication
References: Abeysekera: Anaesthesia 2005; 60:220 -227
Currie: Anaesth Intensive Care 1993; 21:596-601
Anesthesiologists are unique
Anesthesiologists are unique among physicians in their involvement of drug administration
- Diagnose, select medication and dose, personally administer medication in real time
- Many of the current technological protections are ineffective
- Between 40 and 50 steps are required to administer an IV bolus of medication in the operating room
- Practices contributing to errors in the anesthesia environment
- Failure to check (17 percent)
- Distraction (16 percent)
- Inattention (13 percent)
- Haste or pressure to proceed (12 percent)
- Drug labeling / similarity (11 percent)
- Communication lapse (9 percent)
- Fatigue (9 percent)
- Unfamiliar workplace (7 percent)
- Staff change – relief (3 percent)
- Inexperience (2 percent)
- Inadequate knowledge (1 percent)
References: Webster, Merry et al: Anaesth Intensive Care 2001; 29:494-500
Abeysekera et al: Anaesthesia 2005; 60:220-227
Techniques to reduce drug administration errors
- Pre-filled syringes
- Distinctive drug labels
- Colored drug labels
- Check labels with second observer
- Do not store concentrated solutions of hazardous medications in the operating room
- Standardization of drug preparation procedures
- Standardization of layout of drug workspace
- Standardization of syringe sizes.
- Bar codes on drug labels with audible reader
- Strategies that reduce complexity and assist rather than attempt to replace the human being are most likely to improve safety
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Deep Sedation for Non-Anesthesiologists
By Donald E. Martin, M.D.
In December 2009, the Centers for Medicare and Medicaid Services (CMS) revised the Medicare conditions of participation to require anesthesia services to provide oversight of all providers delivering all sedation and analgesia or anesthesia anywhere in a hospital or health care facility. These revisions in the conditions of participation provide both new authority and new responsibilities for the anesthesia services in most hospitals.
ASA, and likely most ASA members, believe that anesthesiologist participation in all deep sedation and general anesthesia is the best means to provide the safest care. However, non-anesthesiologists commonly provide moderate or “conscious” sedation at various locations throughout our hospitals, and in some cases non-anesthesiologists also provide deep sedation, particularly in the emergency room and critical care areas.
Guidelines have already been developed for non-anesthesiologists to administer minimal and moderate sedation. However, guidelines approved this year for the first time set standards for non-anesthesiologists to provide deep sedation. These guidelines specify in some detail the education and training, the licensure, and the performance evaluation required before granting initial privileges, and ongoing performance improvement activities required for non-anesthesiologists to administer deep sedation.
These recommendations allow considerable flexibility for individual institutions to meet their own needs. However, the recommendations do stipulate specific training in various areas, ranging from preoperative evaluation and including:
- Evaluation of the airway and aspiration risk
- Sedative pharmacology
- Ventilatory and cardiovascular function
- Physiologic monitoring and emergency management of the airway before administering deep sedation
These guidelines will soon be available on the ASA website and may provide useful guidance to anesthesia departments, hospitals or ambulatory surgery centers, as they prepare to meet their new responsibilities for maintaining similar standards of care during all levels of sedation and anesthesia, no matter where or by whom it is administered within a health care facility.
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Update on Basic Anesthetic Monitoring
The standard for basic anesthetic monitoring of ventilation using exhaled carbon dioxide was expanded to include the recommendation “during moderate or deep sedation, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure or equipment.”
One practice guideline that was not approved but still has very important implications for our daily practice in the future is the “Practice Guideline for Central Venous Access.” This practice guideline was not approved in its current form. However, the primary recommendations for asepsis during central line placement, and particularly the use of ultrasound guidance for the placement for internal jugular catheters, are supported by sound scientific evidence and will likely become a part of practice advisories and practice guidelines for both ASA and other organizations in the near future.
Therefore, individual departments of anesthesiology should begin planning now to have the equipment and practices in place for the use of ultrasonic guidance for the placement of most central venous access catheters in the future, at least those placed by the internal jugular route.
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