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When Regulation Misses The Mark

When I think of regulatory bodies, I see an opportunity. Yes, there are minimum standards that need to be enforced. However, few people spend as much time in multiple healthcare facilities as surveyors. Their cumulative knowledge of the issues combating healthcare today and the known solutions should be vast ! But instead, what we see are decisions that seem to battle against our care of the patient. In the United States, there are several CMS approved healthcare accrediting programs (CMS Organizations ). All function in a similar way to insure that hospitals and healthcare organizations meet the minimal standards of care. However, they suffer from the same process weaknesses as well. Let me explain.

A typical survey from one of these organization involves a panel of well experienced people reviewing policies and procedures in your organization and making sure you are following them. Additionally, they find weaknesses or patient safety gaps and make recommendations to improve them. It’s a well established process and mostly nerve racking for the organization being surveyed. Included in this process is the contribution that surveyors make when referencing unique or exemplary solutions from facilities surveyed.  However, often it seems that recommendations made occur with a focused lens on an issue and without consideration of the greater picture (overall process of patient care). In these cases, it becomes the burden of the healthcare organization to point out why solutions being suggested would negatively impact patient care. I do not know how surveyors at your facility are conducted, but the ones I have seen at several facilities have strikingly little back and forth conversation or disagreement with the surveyor. Here are a few simple examples:

Hemoccult developer: A facility  removed Hemoccult developer from the bedside. It was a decision made by several other institutions and it was recommended by a surveyor. The premise was that the process of “certifying” people to use it had to be documented and the developer itself had to be placed in a controlled environment so as not to allow someone to ingest it. You may ask what evidence there is to support that claim, and you will find none. There are no case reports of ingestion. Additionally, the package insert for the developer notes that the solution is combination of peroxide and ethyl alcohol. Well, if there are no ingestions, then there must be a need to track competency in its use, right? Hospitals already have in place education programs for the myriad of procedures that nursing and staff might need to perform as part of their duties. Would it be difficult to add Hemoccult use as an education item? No. Does it require proof of competency? Hardly. It is a 10 second procedure easily explained in an equally short video. Yet, the recommendation was not to add the education campaign. It was “remove it from the bedside and place it in the lab”. That decision caused delays for every single patient receiving a rectal exam for occult blood testing for years. As the ED volume increased and wait times swelled, this one decision was responsible for adding a significant amount of time to a specific population of patients. The ultimate result was that it became a standard in so many institutions that I find very few people who recall the days when the developer was at the bedside. It took no less than 3 years and numerous regulatory compliance reviews to prove that Hemoccult developer could be returned to the bedside. What could we have accomplished had we used that effort to tackle patient boarding?

Gauze: Another facility had removed clean gauze from the cabinets in the rooms. The rationale? A surveyor had voiced concern over the unsecured cabinet and the possibility of gauze contamination. So, large containers of clean gauze were no longer being stocked. Instead, single gauze packets (sealed, sterile) were stocked. This passed the survey but again hindered patient care. Have you ever seen someone try to open 10 sterile gauze packets while trying to hold pressure on a bleeding scalp wound? Have you seen a nurse frantically open packet after packet of single gauze packages while a physician is waiting to pack a bleeding wound at the bedside? or visualize a cervix during uterine hemorrhage? This decision greatly impacted patient care. However, the surveyor’s opinion carried all the weight of regulation and no objections were voiced.

Lidocaine: This ubiquitous medication is used to anesthetize the skin for painful procedures such as lacerations repairs, abscess incision and drainage, foreign body removal, and line placement. It was recommended by a surveyor that any sealed, sterile, central line kits containing the medication be securely locked away and not simply stored in a unlocked cabinet. The rationale? A patient might open a cabinet, open a kit, and take the medication. Little thought was devoted to understanding why these kits are deliberately stored for easy access, unlocked. Scenarios when they are necessary can be tenuous, and patients can be critical. In that moment, the delay to find a key or remember a code can impact patient care. Once again, there was no objection from the team accompanying the surveyor or request for the “evidence” leading to the recommendation. What could we have been focusing on instead?

Verbal orders: Several years ago, one regulatory organization launched a campaign against verbal orders. The rationale? Word of mouth between two providers leads to medication errors, therefore 1) there should be a standardized process for repeating the orders back to insure understanding (a great idea), and 2) the use of verbal orders should be discouraged and limited as much as possible. This second recommendation led facilities to develop housewide campaigns against the use of verbal orders. Although there was the stipulation “unless it is an emergency” the staff were instructed that true emergences were rare. In an emergency department, that is not the case. Verbal orders are utilized (or should be) routinely. The outcome, providers began spending more time with computers entering orders for things previously given verbally, while patients waited longer to see providers AND waited longer to receive medications because the provider had not input them yet.

Some have said that it is our role to inform the surveyor of the patient impediment their suggestion might be causing. But again, these are inspectors who spend their time going from one healthcare facility to another. Is there no forethought to their recommendations? Are they not supposed to be experts of their trade? Wouldn’t it serve their goals and that of their “customers” to focus on some of the larger issues that institutions are struggling with now? perhaps share common solutions, and discuss applications for boarding? staffing shortages? process improvements shown to improve healthcare delivery?

In defense of the surveyor, I can only offer one reprise. I have seen numerous cases where a solution is identified by a  manager with poor understanding of the initial citing or deficiency. In that scenario, the surveyor is only partially at fault. They are still responsible for bringing focus to minor issues, but management is to blame for the ultimate decision that is hindering patient care.

What if the next time you invited a regulatory body to survey your facility, they came equipped with a manual of some of the biggest issues facing hospitals today? What if that manual included a detailed review of how other institutions had resolved their issues and a few tips on implementation? What if the survey reports listed items known to greatly impact patient morbidity and mortality, and items of little impact were relegated to discussion only? Would that be sufficient to help facilities spend less time building barriers to the care of the patient and more time tackling some of our largest issues? The potential is great, but the execution has been frustrating and disappointing.

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