The Committee on Quality Management and Departmental Administration (QMDA) receives many questions each year from ASA members about a variety of issues predominantly related to quality-of-care standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and other regulatory requirements. This article summarizes several of the “hotter” issues addressed over the past couple of years.

Implementing Policy for JCAHO Patient Safety Goals for Monitoring
JCAHO approved the 2004 National Patient Safety Goals (NPSGs) in July 2003. NPSGs are not standards, but, as of January, hospitals are being surveyed for these goals. The goals include improving accuracy of patient identification, effectiveness of communication and safety of high-alert medications while eliminating wrong-site and wrong-patient surgery, improving infusion pump safety, improving effectiveness of clinical alarm systems and reducing nosocomial infections. Details are available on the JCAHO Web site at <www.jcaho.com/accredited+organizations/patient+safety/npsg.htm>.

Although there are no requirements for performance measurements relating to NPSGs, there is a requirement to be in compliance with the goals and their specific recommendations. For example compliance with Goal 1 requires that prior to the start of any surgical procedure, a final verification process must confirm the correct patient, procedure and site. With that in mind, ASA assisted JCAHO, along with more than 40 other major organizations, in the development of a universal protocol for preventing wrong-site surgery. This protocol can be found at <www.jcaho.com/accredited+organizations/patient+safety/universal+protocol/index.htm>. Goal 6 also has raised concerns from members about compliance requirements. This goal intends to “improve the effectiveness of clinical alarm systems (by requiring institutions to): a) implement regular preventive maintenance and testing of alarm systems” and “b) assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit.”

While it originated from the “Sentinel Event Alert” on ventilator-related events, JCAHO has expanded the scope to the “full spectrum of alarm systems that are triggered by physical or physiological monitoring of the individual.” Alarms must be activated, set properly and sufficiently audible for the practice setting in which they are applied. Again there is no specific requirement for documentation, but JCAHO reviewers may evaluate compliance by direct observation in an operating room or postanesthesia care unit (PACU). It is not yet clear exactly how “appropriate settings” in the operating room will be surveyed.

Locking Anesthesia Carts — JCAHO and Others’ Regulatory Requirements
This issue has a history resembling an unending fugue. Representatives from QMDA have consistently tried to educate our regulators and accreditors about the substantial unintended consequences of locking carts, including not having equipment and drugs needed for emergency intubations and airway management, vasopressor support, treatment of ischemia, etc. These are the sentinel events that plague the first few minutes that patients are in the operating room (O.R.), especially in the case of sicker patients. Prompt intervention in these instances prevents death. Over the last decade, JCAHO has developed a practical approach to drug security that requires drugs to be secure but does not require locking them away from immediate access. This is reflected in the newly reorganized 2004 Comprehensive Accreditation Manual for Hospitals. In particular the chapter on medication management, MM.2.20, requires that “Medications are properly and safely stored throughout the organization.” The scored element of performance requires that medications be secured so that unauthorized persons cannot obtain access. JCAHO interprets this to mean that medication carts must be secure but not necessarily locked. Drugs left unattended in the open violate the standard. Secured O.R.s with constant supervision should not need to have drug carts locked. The Centers for Medicare & Medicaid Services (CMS) — ironically located on Security Boulevard in Baltimore, Maryland — require a lock to ensure medication security. Therefore JCAHO may use this interpretation of “secure” if the hospital is using the survey for Medicare certification (deemed status). ASA, through the work of QMDA, is in the process of formulating a position statement designating the operating room as a secure area that does not require physical locking of carts. The policy, currently in draft form, is an attempt to resolve the differences between the regulatory interpretations of JCAHO and CMS.

Issues Related to Sedation by Nonanesthesiologists
The guidelines promulgated by ASA in the mid-1990s in this area are based on the skills and measures necessary to handle the continuum of sedation. Individuals providing moderate or deep sedation and anesthesia should have, at a minimum, some form of competency based education, training and experience in evaluation of patients before the procedure, performing moderate or deep sedation and rescuing patients from a deeper-than-desired level of sedation or analgesia. JCAHO interprets the ability to rescue patients to include demonstrated competence in airway management to provide adequate oxygenation and ventilation for moderate sedation along with competence to manage an unstable cardiovascular system for deep sedation.

Each organization is free to determine the required credentials of persons permitted to administer moderate or deep sedation. Acceptable examples offered by JCAHO include, but are not limited to, advanced cardiac life-support certification or satisfactory completion of a written examination or mock rescue developed in concert with the institution’s anesthesiologists.

Whether nonanesthesiologists should demonstrate intubation skills as opposed to general airway management skills to receive credentials for deep sedation is not resolved. Consequently ASA representatives to JCAHO’s Professional Technical Advisory Committee will continue to carefully monitor changes to the accreditation process. Changes in state law also will need the careful attention of both ASA and state component societies as moderate and deep sedation becomes more popular in office settings.

This summary is too brief to serve as a comprehensive guide, and it omits many other areas of concern to ASA members who have corresponded with QMDA. These include appropriate exceptions to sedation standards for intensive care unit (ICU) patients, differences between the standards of care and documentation applicable to patients recovering in a PACU as opposed to those directly admitted to the ICU, physician health and its role in credentialing and privileging, distribution and refrigeration of blood in O.R.s, the timing and elements of the preinduction check, controlled substances, informed consent, obtaining medications by O.R. nurses for anesthesiologists, preoperative evaluation and re-evaluation, demonstrating competency for credentialing and privileging, definition of licensed independent practitioner, how to share quality information without violating the Health Insurance Portability and Accountability Act, labeling of medications and syringes and how to deal with patients who have do-not-resuscitate orders. QMDA regularly corresponds with individual ASA members who request assistance in addressing such questions related to quality of care and regulatory issues related to accreditation.

Bibliography:

JCAHO responses to frequently asked questions regarding standards <www.jcaho.org/accredited+organizations/standards+faqs.htm>.

JCAHO responses to frequently asked questions regarding national patient safety goals <www.jcaho.org/accredited+organizations/patient+safety/npsg.htm>.

Joint Commission on Accreditation of Healthcare Organizations. Comprehensive Accreditation Manual for Hospitals. 2004.

Practice Guidelines for Sedation and Analgesia by Nonanesthesiologists. Anesthesiology. 2002; 96:1004-1017.

Jerry A. Cohen, M.D., Associate Professor of Anesthesiology, University of Florida, Gainesville, Florida.

Robert S. Lagasse, M.D., Professor and Vice-Chair, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York.