Analysis: New Hospital Accreditation Agency Falls Short

Abstract

A hospital that wants to participate in Medicare must meet its standards—Medicare Conditions of Participation for Hospitals, 42 CFR §482—and receive accreditation from an organization that the U.S. Centers for Medicare & Medicaid Services (CMS) approves as a “deeming authority.”In September 2008, CMS approved DNV Healthcare for that role, and it is now the third accrediting organization for hospitals that want to be reimbursed by Medicare and most other third-party players. The other two such groups are The Joint Commission and the American Osteopathic Association.Here's a look at the DNV program and how it compares to that of The Joint Commission.DNV Healthcare is a subsidiary of Det Norske Veritas, a private, non-profit, Norwegian-based foundation. More than 100 years old, Det Norske Veritas says its purpose is to “protect life, property, and the environment” by advising and setting standards for many industries. It uses or incorporates International Organization for Standardization (ISO) standards as the basis for most of its work. While it has been involved with healthcare for about 20 years, DNV only got started in hospital accreditation with its acquisition of TUV Healthcare Specialists in 2007.To date, more than 120 U.S. hospitals have either achieved DNV accreditation, are awaiting their first survey, or are in the process of contracting with DNV. Recently, DNV has started expanding their hospital accreditation program to other countries.DNV's accreditation program is called National Integrated Accreditation for Healthcare Organizations (NIAHO). For now, its standards are applicable to hospitals only, although it is planning to develop accreditation programs for other healthcare specialties. Perhaps the most unique feature of NIAHO accreditation is that it incorporates the ISO 9001 Quality Management System Standards, one component of the ISO 9000 standards family. Getting an ISO 9001 certificate is an extra-cost option, but it's a major reason some hospitals choose to obtain DNV accreditation.Another unique feature of NIAHO accreditation is that the accreditation surveys, which are unannounced, are annual. The length of a survey and the number of surveyors are determined by the size and complexity of the organization being surveyed. All survey teams include at least two members—a nurse or physician, and a physical environment specialist. Another unique feature of NIAHO accreditation is that the standards and related literature are available free at: http://www.dnv.com/industry/healthcare.The DNV's accreditation standards for hospitals are published in National Integration Accreditation for Healthcare Organizations Accreditation Requirements (AR). The current version, only 53 pages, was published in September 2009. The standards were developed by specialists in each subject area in the AR. Since the standards are tied to the CMS Conditions of Participation and to ISO 9001, they are subject to change only when the Conditions of Participation or ISO 9001 change.The DNV's AR contains only their standards, unlike The Joint Commission's Comprehensive Accreditation Manual for Hospitals (CAMH), which includes standards plus explanatory materials. Separately, DNV does publish NIAHO Interpretive Guidelines and Surveyor Guidance (IGSG), which is also available free online. Educational programs are available, with the schedule posted on the DNV website.The AR has 25 chapters, including one entitled “Physical Environment,” which is analogous to the “Environment of Care” chapter in The Joint Commission's accreditation manuals. The “Physical Environment” chapter includes a section called Medical Equipment Management System.There are seven standards for medical equipment management in the AR. They are:Overall, the DNV standards for clinical engineering are very similar to the JC standards (Figure 1). The JC CAMH has 15 elements of performance that are specific to clinical engineering; the AR has seven requirements for clinical engineering. The AR doesn't have a written requirement for an equipment inventory or for equipment repairs. The CAMH doesn't have a requirement for equipment user training in its equipment standards. (It used to be there, but is now covered in the more general education and training standard in the “Human Resources” chapter.)In DNV's IGSG, the difference from JC standards becomes more distinct. In the interpretive guidelines section, it specifies that inspections and maintenance must be in accordance with the manufacturer's recommendations, along with federal and state laws and regulations. It requires that the medical equipment plan address the use and training for demonstration and rental equipment. Information on equipment repairs and periodic maintenance is included in the surveyor guidance section. This section states that “all medical devices and equipments are routinely checked by a clinical or biomedical engineer.” This section also contains a number of requirements for supplies—for both operational and emergency needs—even though there is no mention of supplies in the AR itself.Good standards should be well written, justifiable, and complete. I can find fault with all three aspects of the DNV standards for clinical engineering.The standards are not written clearly. Perhaps the best (worst?) example of a poorly written standard is SR.2. Besides being a poorly worded sentence, this standard appears to apply only to “issues related to” rental or physician owned equipment. Nowhere else in the standards is there any requirement for incoming inspections or for user training of all other medical equipment. I asked for clarification on the intent of this requirement from DNV staff. They explained that the intent of the requirement is that when equipment is purchased, there is an initial service inspection and orientation. In addition, if the equipment is rented or physician owned, there must be a demonstration. I believe that the wording of the requirement is too easily misinterpreted.I also have an issue with the fact that there is no mention of biomedical equipment technicians. The interpretive guidelines state that “a clinical or biomedical engineer or other qualified maintenance person” must maintain equipment. As stated in the surveyor guidance, all medical equipment must be routinely checked by a clinical or biomedical engineer. BMETs are better qualified by education, training, and experience to do all medical equipment maintenance—scheduled or unscheduled. There is no group more qualified to maintain medical equipment than BMETs, and they outnumber clinical and biomedical engineers in hospitals more than 100 to 1.As stated in the interpretive guidelines, manufacturers' testing and maintenance recommendations must be followed. But I believe manufacturers' recommendations are often a waste of time (e.g., when they require too frequent or too detailed inspections). Experience shows that all medical equipment does not need routine inspections, and evidence-based inspection procedures are more effective and economical.The DNV's AR standards are not complete. They do not explicitly require an equipment inventory or equipment repairs. One could probably argue that these are implicit in other standards, but requirements shouldn't be implied. An equipment inventory and equipment repairs are among the more important aspects of a clinical engineering function, and should be explicitly required. It isn't until you read the surveyor guidance section that you find out that the surveyors will be looking for a repair program. The surveyor guidance also requires “maintenance logs for significant medical equipment.” This suggests an inventory, but only for “significant” equipment. It includes some examples of significant equipment, but no definition, so this would obviously be open to interpretation. Do they want hospitals to develop their own list of significant equipment? If so, would this amount to something similar to the JC's inventory based upon risk categorization? We shouldn't have to guess.Randall Snelling is the chief physical environment officer at DNV Healthcare. He interprets the standards and trains surveyors pertaining to the “Physical Environment” chapter. I had a lengthy discussion about the medical equipment standards with Snelling. He explained that all NIAHO standards were written to comply with the CMS conditions of participation requirements and ISO 9001 standards. He emphasized that their physical environment standards, including for medical equipment, are collaborative, not prescriptive. Hospitals can establish their own medical equipment management programs if adequately described, explained, and justified. He believes that clinical engineers and BMETs know what needs to be done. He said that, during surveys, they always interview the clinical engineering manager. Their most common findings are that BMET training is not documented and that non-hospital owned equipment is not inspected.It was very interesting that we agreed on the fundamentals of medical equipment management programs: There should be a plan, the plan should be implemented, performance should be measured, and there should be continuous improvement. He reiterated that this is what surveyors looked for. However, I argued that their standards and their guidelines were not written that way. I believe that both the standards and the guidelines are prescriptive, and leave no room for alternatives. He said that this was not the intention, and that he would review them in light of my comments. He feels that SR.1, which requires a medical equipment management system, requires hospitals to develop a comprehensive program while allowing them to develop one that meets their unique needs. He said that anyone with questions or comments about the medical equipment management standards could contact him at Randall.Snelling@dnv.com.The people with whom I discussed the DNV standards clearly believe that it is appropriate for hospitals to develop their own programs that meet their unique needs and that are based on their expert experience. Unfortunately, CMS conditions of participation require hospitals to follow manufacturer recommendations for maintaining medical equipment. So, DNV would appear to be caught between a rock and a hard place. They have written their standards to comply with CMS's prescriptive requirements, but claim to interpret them more flexibly.