Rigid regulation can become detrimental to patient care


The last four days have provided a sharp glimpse into the future that awaits those of us in the health care profession, physicians in particular. Over the last few years physicians have been burdened with mountains of paperwork, most of which contributes little to patient care, but does take time away that could be better utilized caring for our patients. However, the last four days have demonstrated that the administrative load that has encumbered us is now become a hindrance to proper patient care. The following occurrences are all actual events, each happening at the same hospital over a four day period.

Four days ago, while making my standard visit to my patient in the pre-op holding area, one of the nurses informed me that, per the Surgical Care Improvement Program (SCIP), my patient needed to receive different antibiotics than the one I had ordered. The patient was to undergo a laparoscopic biopsy of a retroperitoneal lymph node, with the possibility that she may require an open surgery, which would necessitate a much larger incision in her abdomen. Laparoscopic surgery is done with very small incisions, working through small cannulas, the operative field displayed on a high resolution monitor. The antibiotic I had ordered was Cefazolin, perfectly appropriate for the scheduled operation. The nurse informed me that, because there was the possibility the operation could be converted to open, she also had to receive Metronidazole in addition to the Cefazolin. I told her that the particular antibiotics she was insisting be administered were indicated if the patient was undergoing colo-rectal surgery, but all that was needed in this particular case was the Cefazolin. She replied that she was following the SCIP protocol and she would get in trouble if I didn’t order the Metronidazole. Not wanting to argue with the SCIP police, I ordered the additional antibiotic.

That same day I was to perform a major surgery on an elderly lady who had a large tumor in her abdomen; a tumor the size of a volleyball. The preoperative evaluation suggested that it could have been a large cyst that, perhaps, could have been removed laparoscopically. However, when I reviewed her CT Scans (X-Rays) prior to surgery I was very doubtful that the surgery could be properly performed without a regular incision. I informed the OR crew that I would take a look with the laparoscope, but that almost certainly the surgery would be open and to be prepared. The surgical tech and circulating nurse did everything correctly, having both laparoscopic and open instruments opened and counted from the start of the operation. A quick look with the scope confirmed my suspicions and the surgery proceeded through an eight inch upper abdominal incision and the tumor, which was arising from her stomach, was removed, along with about ¾ of her stomach. As the surgery neared its completion I was informed that policy mandated that an X-Ray be done. I asked the reason why and was told that because we had converted from laparoscopic to open surgery, an X-Ray was required to confirm that no sponges or instruments had been left inside. I tried to explain that we had more or less planned to open the patient with a regular incision and all the instruments and sponges had been counted. The response was that it was corporate policy and I had no choice. The patient remained under anesthesia for an additional twenty minutes while the unremarkable X-Ray was obtained.

As this particularly surgery neared completion I informed the circulating nurse that I thought this elderly patient would need monitoring during the immediate post operative period and I requested that she go to the Intermediate Care Unit, which is a step below Intensive Care. A few minutes later I was informed that my request would require approval by the Case Manager, a nurse employed by the hospital whose primary job is to facilitate smooth transitions for patients preparing to leave the hospital. I asked what would happen if the Case Manager denied my request. No one had an answer; luckily, the patient apparently met the criteria for IMCU monitoring. Such criteria is a closely guarded secret, privy only to those that have been accepted into the Case Management Guild (not really, although it frequently seems that way).

Two nights later I was on call for the Emergency Room. I received a call at about 10:30 pm from the ER physician requesting that I immediately come to the ER to attend to a Level I trauma that had just arrived. He took the time to explain that the trauma was a BB gun shot to the shoulder area and that a Chest X-Ray had already been done which was normal except for the BB which could be seen overlying the right clavicle (collarbone). He added that there was a small amount of swelling over the area the BB had penetrated, but otherwise everything was normal. My logical response was “Why do I need to come in to see a patient who obviously can be discharged home with an ice pack, antibiotics and pain med?” I was told by the nurse in charge that once a patient has been declared a “Level I” trauma I was mandated to see the patient within 30 minutes and only I, as the trauma surgeon on call, could make the decision to downgrade the trauma level. The trauma protocol clearly states that all penetrating wounds to the thorax be classified as “Level I”. The fact that this particular patient did not have a penetrating injury to his thorax was deemed irrelevant by the nurse who made the decision. The fact that the ER physician had evaluated the patient and determined that there was no significant injury was also deemed immaterial. I did get to meet a very pleasant family who were happy to be reassured that their son had not suffered any serious injury.

The final incident happened the following morning. A 13-year old boy was admitted at about 5:00 am with an uncomplicated appendicitis. The OR was busy at that time, so the boy was scheduled for surgery later that morning, around 11:00 am. I saw the patient about an hour before surgery and, during my evaluation noticed that IV fluids were not being administered. I asked the nurse why and she informed me that pharmacy had not sent her the proper fluids. The fluid ordered was Lactated Ringers, one of the most commonly utilized IV solutions in the hospital. The nurse stated that they did have that particular fluid on the floor, but policy was that pediatric patients had to receive their IV fluids from 500cc bags and they only had 1000cc bags on their unit. This makes perfect sense if the pediatric patient is a baby, but this patient was adult sized. He had been in the ER for several hours, had been on that particular unit for five hours and had eaten very little the previous day. All this made for a significantly dehydrated patient; one who was to be going to surgery a short while later. The nurse informed me that she was not allowed to go against policy. I asked her if she had considered calling to inform me of the dilemma, but she hadn’t. She had been on the phone with pharmacy half a dozen times, but they still wouldn’t send her the proper 500cc bags of Lactated Ringer’s solution. Eventually, the boy received the fluid as ordered and he underwent an uneventful laparoscopic appendectomy.
These five scenarios have a common thread. They all illustrate that rigid adherence to written policy can be detrimental to our patients. As best as I can determine none of these five patients actually suffered or had any morbidity; but in none of these instances did the policy enhance the patient’s care or contribute to an improved outcome.

In each instance, however, there was real potential for injury. Administering unnecessary antibiotics opens the door to potential side effects, some of which can occur after only a single dose. Disruption of normal, symbiotic bacteria by the administration of antibiotics can cause transient diarrhea or severe colitis, while allergic reactions are always unpredictable. And, of course, the whole purpose of the SCIP program is to administer appropriate antibiotics in the appropriate manner. Yet, here is an example of the SCIP administrators, who are not physicians, insisting on inappropriate antibiotics. Every surgeon learns, as part of their training, the proper way to administer prophylactic antibiotics, which medication to order for which procedure and for what duration. But, surgeons also understand that there are often situations where deviation from the usual regimen is not only allowable, it may be vital and life saving.

The requirement that an X-Ray be obtained if a planned laparoscopic surgery converts to open is certainly reasonable. Very often, the conversion needs to be done expeditiously and there may not be time to count instruments and sponges properly. However, if such a conversion is planned and all the usual operating room procedures have been followed and the ending sponge, needle and instrument counts are correct, the immediate post operative X-Ray is a needless waste of time and money, besides requiring the patient to remain under anesthesia for an additional 20-30 minutes. It is usually in the patient’s best interest to perform operations with as little wasted time as possible. I believe the policy, which was written by corporate attorneys not physicians, is correct; the administration of this policy, in this instance, was not.

The necessity of seeking the approval of Case Management for post operative monitoring is simply wrong. The surgeon best knows what occurred during the procedure and the co-morbidities the patient may have. The need for ICU or IMCU monitoring should be a decision left only to the physicians caring for that patient.

The patient with the BB to the clavicle was a case of bureaucratic overkill. Trauma is an area where certain protocols have been proven to improve survival. The first hour, the so called “Golden Hour”, is an important time of resuscitation and evaluation of the critically injured patient. However, in this situation it was obvious to everyone involved that the injury suffered was minor. Such strict adherence to protocol didn’t harm the patient and was only an inconvenience to me, as I needlessly come into the hospital late at night. However, in this particular hospital there are only three General Surgeons taking call, often we are being called all night. Unnecessarily calling one of us does put a strain on system that is already overtaxed. Such stress, theoretically, could lead to poor performance by the on call surgeon.

Finally, the last case; the failure to administer ordered IV fluids. Of all these events, this is the one with the most potential for harm. The patient with appendicitis often has had poor oral intake for the duration of their illness, usually 1-3 days and thus may be dehydrated. In addition, intra-abdominal inflammatory processes often result in significant body fluid shifts into the area of inflammation. Adequate fluid resuscitation is one of the first things a medical student learns. Withholding IV fluids because the right bag wasn’t available caused this necessary surgery to be delayed; waiting for the patient to be adequately hydrated. The appendix in this case was very inflamed, about to rupture. The nurse should have informed me or her superior of the difficulty she was having with pharmacy so that the situation could have been remedied in a more timely manner.

All the protocols and policies that are developed are supposedly designed to help optimize patient care and improve outcomes. At what point is this goal lost? Starting in medical school physicians are taught that every patient is an individual, residents, no matter what their specialty, are taught to approach each patient with a fresh perspective and treat that individual’s unique problems with a therapeutic plan designed specifically for that individual.

Cookbook medicine, inflexibility and strict adherence to sometimes arbitrary rules developed by administrators and lawyers are destined to clash with the individuality that is inherent to a physician’s approach to their patients and the provision of what we doctors hope is high quality patient care. Physicians study textbooks during medical school and residency; one of the main things we learn from these books is that the majority of our patients are not textbook cases. Why should those individuals that are trying to formulate policy and protocol assume otherwise?

Why have all these rules and regulations been developed? What has happened in the medical profession that has caused government, insurance companies and hospital administrators to be compelled to draw up an ever growing mountain of rules, protocols, policies and forms that are heaped upon the shoulders of doctors and nurses, thus weighing us down and ultimately interfering with the quality patient care they are trying to deliver? I don’t have all the answers, but I believe there is a perception among non medical professionals that the health care system has let them down. The study done years ago, widely trumpeted by the media, that there were thousands of deaths caused by medical errors, fueled this drive towards creating a standardized approach to medicine. But, of all professions, medicine is the one that least lends itself to such an approach. The human body is a remarkable creation, able to withstand unimaginable insults and attacks. Sometimes, however, the body breaks and the doctor is called to evaluate, diagnose and treat the ailment. This is where the art of medicine comes into play. And it is an art; a combination of judgment, experience, insight and, sometimes, a bit of intuition. To try to create a cut and dried recipe for every conceivable clinical situation will lead to mediocrity and less than acceptable outcomes.

Should doctors be allowed to run wild then? Certainly not. It is the responsibility of our medical schools and residency programs to teach and train the physicians of tomorrow to be informed, conscientious, and diligent; always putting the needs of the patient first. Students who fail to measure up should be steered into areas where their particular aptitude is best suited. Students who are perceived by the teaching faculty to be lacking the proper skills to be a quality physician should be directed into other fields. Once finished and out in the real world doctors always need to keep the patient’s needs in sight. At the same time our health care administrators need to allow doctors to practice unencumbered and, if a physician persistently performs in a substandard manner, corrective measures should be instituted.

This brings us back to the problem at hand. Rigid regulation, as I have attempted to demonstrate, can become detrimental to patient care. Every aspect of health care should be directed towards optimizing patient care and improving outcomes. Clinical guidelines may be helpful, but it must be remembered that they are guidelines only. Doctors now are forced to follow an ever growing list of rules and protocols which have never been shown to improve patient outcomes, but do carry the potential to be a detriment to patient care. Nurses are threatened with a variety of sanctions if they deviate from these protocols; protocols that have never been adequately explained, the rationale for each protocol remaining a mystery to many of these nurses. Indeed, I have been to meetings where the administrators who formulated these policies have demonstrated that they are totally clueless as to the reasons each protocol was established in the first place. Provisions in the Affordable Care Act call for the creation of more protocols and policy, attempting to standardize health care delivery. Such a plan can only be successful when humans are built in the same way we build cars and computers, everyone the same and with identical, interchangeable parts.

The United States has long been cited as having the best healthcare system in the world. It is the doctors and nurses who deliver this care that built this great system. Let them do what they have been trained to do.

David Gelber is a general and vascular surgeon who blogs at Heard in the OR and author of Behind the Mask.

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