Be honest: does honesty pay during a survey? Questions concerning ethics and morality produce volumes--what is interesting in regards to hospital surveys is that for the Clinical Engineering department, just answering the question can pose some real risks. Here's what I mean.

BME may be the only department (in the U.S. at least) for whom documentation is an absolute requirement, yet for whom there are no defining criteria to follow concerning the form that documentation takes and how it is put to use. Huh? You say? Huh is right. Clinicians, Blood Banks, departments that perform sterilizations, all must keep specific kinds of documentation that clearly illustrate exactly what they do, when they do it, and how often they do it; the criteria is mandated and must be presented to a surveyor.

Not so for BME. Clinical Engineering departments are mandated to keep various kinds of records, to be sure, but the specifications describe only an undefined form of equipment management program, using language that is vague and undefined, with no requirements as to what must be presented, or the detail that must be included in a required format. Furthermore, various terms such as "compliance" and "corrective maintenance" should be defined--indeed, the word "compliance" doesn't even show up in the JCAHO 2003 Standard, but everyone presumably knows what it's worth.

In short, because instrumentation is varied in terms of medical specialties, and broad in its application of technology, the methodologies and rationales applied to maintenance remain unique to every institution. The BME department is simply left to demonstrate that what it says it does, it does, while walking on egg shells so as not to stimulate a surveyor to "dig down" (a JCAHO term) any deeper. After all, dig deeper into forms, statistics, and procedures mandated but not defined, and the department may have to explain what it may not have reasoned out prior to the survey.

The measure of success of a department is left to the "drilling down" process of a surveyor, who may or may not insist on certain documentation and procedures--depending on who he is, what his particular expertise is, and possibly what he had for breakfast that morning. If the airline industry were run in this manner, planes may fall from the sky at a faster rate than they do.

Airline oversight is not an unfair analogy; the dissimilarities between medical and airline oversight are glaring and frightening. Aircraft must receive certain specific types of maintenance at certain specific intervals, failures are documented and investigated, the investigations are documented, and the failure rates (planes falling out of the sky) are known--none of this oversight can be claimed in the field of medical instrumentation.

Not establishing exact documentation requirements necessary for meeting standards promotes, among other things, clever and deceptive methods of skirting the intent of survey standards. I know of one BME department Director who separated the inventory receiving maintenance inspections into two categories: "Standard," and "Priority." The intent was to be able to more closely monitor compliance of critical life-support devices during times when staffing was short or when other circumstances impeded the level of maintenance inspections.

Eventually, this Director left, and the new Director saw this form of internal monitoring as an opportunity to lift sagging maintenance compliance ratings. This Director in effect altered the institution's definition of "equipment on the maintenance program" to mean only Priority devices--only that group would have its compliance numbers reported to the Environment of Care Committee and to surveyors. The institution looked better on paper, but certainly not in reality.

But exactly what are we talking about doing? Standardizing maintenance inspections for each and every device--regardless of environment, frequency of use, device age, and other unique criteria? Good idea or bad, I'm not going there. But here--make standard the following: the exact information to be gathered, the definition of terminology such as "compliant," the method of calculating it, and a list of those items that must be reviewed during a survey, not what might be asked for by a particular surveyor.

Medical treatment facilities are suppose to be self-monitored vis-à-vis "self-regulated" industry oversight by those who understand it best. Surveyors do not generally behave as though they do understand clinical engineering in the sense that their digging complies more with idiosyncrasy than with the standards those surveyed are doing their best to comply with. In other words, surveys become a competition between two entities--each gaining expertise at outwitting their adversary, rather than expert at overseeing the issues they are held in trust to guard.

"1918: The ACS begins on-site inspections of hospitals. Only 89 of 692 hospitals surveyed meet the requirements of the Minimum Standard. The ACS officially transfers its Hospital Standardization Program to JCAH, which begins offering accreditation to hospitals in January 1953. Congress passes the Social Security Amendments of 1965 with a provision that hospitals accredited by JCAH are "deemed" to be in compliance with most of the Medicare Conditions of Participation for Hospitals and, thus, able to participate in the Medicare and Medicaid programs."
http://www.jcaho.org

"The Air Commerce Act of May 20, 1926, mandated the beginning of Federal safety regulation of airlines and other forms of civil aviation. The Air Commerce Act of 1926 charged the Department of Commerce with responsibility for investigating air accidents. This function was assumed by the Department’s new Aeronautics Branch, and later by the Branch’s successor, the Bureau of Air Commerce. The Air Commerce Act of 1938 assigned accident investigation to an Air Safety Board within the new Civil Aeronautics Authority created by the act. In 1940, the Air Safety Board was abolished and accident investigation became the responsibility of the new Civil Aeronautics Board. On Oct 15, 1966, the Department of Transportation Act established a new National Transportation Safety Board (NTSB) with responsibility for investigating accidents in all transportation modes. FAA assists the NTSB in the investigation of aviation accidents. Frank Gates Gardner of Norfolk, Va., received the first Federal aircraft mechanic license on July 1, 1927. The Aeronautics Branch of the Department of Commerce began issuing pilot licenses in April 1927."
http://www1.faa.gov

Take a look at the data detail available in the National Transportation Safety Board Database (beware--large file) System Query Form. Detailed information should be gathered and disseminated concerning medical errors. Establishing an effective data management system could lead the way toward creating basic standards in the field of medical equipment maintenance. It would be a start.