Letters to the Editor:
Creation of Observational Unit May Decrease Sleep Apnea Risk
To the Editor:
Dr. Lofsky has done the anesthesia community a significant and positive service by writing about the difficulties associated with the anesthetic management of 8 patients with obstructive sleep apnea (OSA) that arose from the Doctors Insurance Company medical malpractice experience (APSF Newsletter 2002;17:24-5) (as she had previously done in describing 12 cases of vision loss following spine surgery [APSF Newsletter 1998;13:16-7]). On the basis of having done an in-depth review of approximately 10-12 medical malpractice cases involving patients with severe OSA (usually obese) with disastrous respiratory outcomes, I also felt inspired to publically discuss the problem.1-4 Although I agree with just about all of Dr. Lofsky’s statements, I disagree with the statement that respiratory arrest following opioid administration to OSA patients “could have been prevented by audible pulse oximetry monitoring on the ward.” This erroneous comment is very important because if the statement is relied upon to ensure safety, then the practice could lead to more negative outcomes in the future.
The medical system in the United States of America at present, with respect to the intensity of postoperative care, is basically an all (ICU care) or next-to-nothing (patient alone in an isolated room on the ward) choice; there is no middle ground monitoring environment (including visual and electronic surveillance) for the morbidly obese patient with severe OSA, who is receiving narcotics and/or sedatives, who is not intubated, and does not have special lines (tracheal tube, arterial-line, pulmonary artery catheter, Foley catheter, and so forth). In many of the OSA medical malpractice cases I have reviewed, an attempt was made to create a middle ground monitoring environment by placing the patient in a room near the nursing station, keeping the door open, the lights on, trying to have a family member continually present, putting an audible pulse oximeter (SpO2) on the finger and maybe some sort of apnea alarm monitor on the patient. These middle ground monitoring solutions simply do not work; e.g., the family member goes to the cafeteria, no nurse (or any other care giver) passes by the room for many minutes (the door being open and the lights on and the room being near a nursing station then becomes irrelevant), and no one hears any change in the sound of the pulse oximeter and the patient dies.
Postoperative patients with OSA do not necessarily need an ICU, but they definitely need more monitoring care than normal patients. In my opinion, the solution that will work best is the creation of observational units with RN:patient ratios of 1:3-4 with frequent visual observation and noninvasive blood pressure, SpO2, and EKG monitoring at each bed site, as well as at a central bank of monitors at the nurse’s station. The recent development and clinical availability of a remote (by pager) SpO2 and heart rate monitoring notification system, such as the Nellcor “In Touch”™ monitoring system, is a very significant step in the right direction. In the absence of having an observational unit or a remote SpO2 and heart rate pager monitoring and notification system, and in the presence of concerns about the risk of respiratory arrest following narcotic administration to an OSA patient, my advice is to send the patient to the ICU. A simple audible SpO2 monitor in an isolated room on the ward will not work.
Jonathan L. Benumof, MD
San Diego, CA
Value of Pulse Oximetry Monitoring On the Ward Is Questioned
To the Editor:
Thank you for the special article, Sleep Apnea and Narcotic Postoperative Pain Medication: A Morbidity and Mortality Risk, in the APSF Newsletter.1 We anesthesia providers, it is safe to say, are uniformly concerned about the respiratory risks of administering postoperative opioids and sedatives to patients at risk of sleep apnea. We appreciate the Doctors Company for convening an advisory panel to discuss the issue.
I was surprised, however, that the “panel members were struck by the fact that all of the cases [of cardiopulmonary arrest] reviewed could have been prevented by audible pulse oximeter monitoring on the ward.”1 While I do not know of any direct evidence to support this conclusion, I can think of many reasons to question it.
The pulse oximeter has a number of limitations, especially on the general care ward where nurse to patient ratios are low. The oximeter is a “high maintenance” machine. It can be rendered useless by patient motion, probe malpositioning, failure to properly set the alarm volume and parameters, inaudibility of the alarm from the nurses’ station, poor peripheral circulation, and so forth. The machine is plagued by repetitive false positive alarms, to the point that the staff frequently silences the alarm without bothering to check its validity. Indeed, staff is more often than not unable to differentiate a valid alarm from a false one.
We need to find safe, effective, and economical means of delivering postoperative analgesia to the patient at risk for sleep apnea. Until we do, we cannot state that these deaths are preventable.
Kyle S. Fisher, MD
Boone, North Carolina
1. Lofsky A. Sleep apnea and narcotic postoperative pain medication: a morbidity and mortality risk. APSF Newsletter 2002;17:24-5.
Current System May Miss the “Mark”
To the Editor:
At our surgery facility the preoperative nurses routinely have the patient mark “No” on the non-operative side for procedures such as carpal tunnel releases, shoulder cases, and so forth. I have welcomed this because it prevents the performance of surgery on the wrong side . . . or does it? I recently gave general anesthesia to a patient having a knee-scope. The surgeon applied the tourniquet, injected local anesthetic into the joint and the nurse was prepping the knee when I happened to be reviewing the surgeon’s history and physical (to record the correct diagnosis on my billing sheet). At this point I told the nurse that the H&P said left knee although she was prepping the right knee. The lively voices of OR personnel were immediately changed to somber tones and the nurse dejectedly admitted, “Look, I’m prepping right over the ‘No.’”
Many lessons can and should be taken from this case, but the one I'd like to emphasize is this: safety procedures are helpful, but we must not rely on them. Instead, I think, we must promote an overall culture of safety: attitudes, training, procedures, and common sense that combine to create a safe, not fool-proof, perioperative environment for our patients. I would like to ask the APSF to consider promoting the term “culture of safety” and invite further discussion on this concept which obviously ties into the mission of the APSF. I also suggest that the APSF establish a regular column in this newsletter for members to share mishaps or near misses, such as this one, along with comments for the benefit of others.
Thank you.
Name Withheld on Request.
Editor’s Note: The APSF Newsletter continues to welcome reports of mishaps and near misses.
Computerized Anesthesia Record: Value Recognized, Terminology Scrutinized
To the Editor:
I am pleased to see the endorsement by the APSF of computerized records for anesthesia in the APSF Newsletter. As the second anesthesia organization to do so (behind the STA in 1994 or 1995), I hope this will finally give the boost needed for the industry. The industry should be allowed to market these two endorsements. The more important news is the effort toward the data dictionary. This is a difficult task that is long overdue. If successful, this should really get the ball rolling toward dramatically improved care. I hope the participants can keep focused on the definitions (which go far beyond outcomes) and not on the structure or the coding issues. Let the companies each come up with their own “better” way of doing that. However, I am still distressed to see the APSF referring to the technology as “automated records.” No other branch of medicine does this.
They should be called computer-based medical records (CBPRs) or computerized patient records (CPRs). Although parts of the records are automatically recorded, the clinician manually annotates the vast majority of the fields in the record (>70%). Personnel names, drug name, dose route, intubation and spinal information, incision times, tourniquet pressure and time, descriptive notes about the condition of patient, and the state of the surgery are just some of those fields. Furthermore, the rare (1 in 300 anesthesia minutes) piece of automatic data that is erroneous can be annotated in a few seconds. All of this annotation takes far less time than accurately recording the rest of the monitor data by hand. The record is far from automatic. That “A” word and any acronyms using it, like ARK, cause a disservice to the promotion of the technology.
This name for the technology is not just an issue of semantics. It is sales, marketing, and politics. The very same newsletter in which you have endorsed the technology shows the results of your semantics. Namely, the commonly and incorrectly expressed view of Dr. Metz1 that computer records are legally risky proves this. This unsubstantiated fear is promulgated by the use of the term automatic, which implies that the data on the record are out of the control of the clinician. Ergo, this creates the false assumption of legal risk for showing some bad vital signs that did not occur. In my view, this issue of terminology for the technology and the lack of the data dictionary are the two main reasons (out of five) why the industry has had so many failed companies. As a result, many more patients suffer bad outcomes such as emesis and myocardial infarction now than would have occurred had we adopted the technology a decade ago. If that statement is not true, why endorse the technology as a patient safety issue?
If the industry and the APSF would use the more accurate term “anesthesia computer records (ACR)” or some phrase like “computerized patient record for anesthesia (CPRA),” one might not have to keep beating down this dead horse. This issue has hung on since my former department started using computer records in 1988. There have been many white papers, textbook comments, and expert panels at the ASA, STA, and other meetings that have squashed this notion of increased legal risk and yet it hangs on. I have spoken to no JD or JD/anesthesiologist who thinks CPRAs are legally risky. I would wager that Dr. Metz has never done a case with a computerized record keeper and used that record as the legal record. One-day test trials, without proper training, in which the record serves as a duplicate to the hand record, do not count. Insurance companies like St. Paul and Preferred Physicians Mutual encourage their use. Why, if they are legally risky? Maybe the APSF could sponsor a multi-company statement from the insurance industry endorsing the use of CPRAs.
The true legal implications of the ACR are that they are more accurate and more credible than the handwritten record and, therefore, present a stronger legal case for the clinician. Be mindful that they are not 100% accurate but, as shown by every study that has looked at the issue, they are more accurate than the manual record. Ask yourself which of these two scenarios you would rather be in.
You’re on the witness stand defending a record that shows not one blood pressure below 100 systolic. Yet, a surgeon and an OR nurse testified that they heard alarms and saw NIBP pressure below 70 several times. “And by the way, Doctor, why did you give ephedrine when there was no hypotension?” “We know, Doctor, that you lied on the record and you did not deal quickly or effectively with this long and gross hypotension! What else are you covering up, Doctor?” You might as well write the check.
In the second case, you have a record that shows that there was one blood pressure below 70. This occurred 2.5 minutes after one of several blood pressures in the 90s systolic. The record shows that you treated it with 5 mg of ephedrine within 1 minute of its occurrence and then another dose of 10 mg for a blood pressure of 78 systolic. All further blood pressures were above 90. Furthermore, your database shows hundreds of cases of similar age and ASA class with this degree of hypotension with no negative result. (Actually, if your database is like mine was in 1988 when I started to measure hypotension in the department, it is close to 17%. Until you measure and address the issue with the department, you cannot reduce it to 2% as we did by 1993, but that is another story). So you respond to the pushy lawyer, “Why do you postulate that a bad outcome occurred here?” You choose where you want to sit if the courtroom is your worry.
Both these scenarios assume all values are accurate. In fact, my analysis of literally millions of automatically recorded cuff pressures indicates that the value is correct in the vast majority of cases. But, let’s assume that the value is an artifact. Those who fear this issue only assume that the low value is an artifact. As in Dr. Metz’s discussion, it does not include the more likely possibility that the value is a true value. If the value is an artifact, is it really that bad to have a value of 60/40 one time with a note saying the patient is shivering? This note is written on the spot within a minute or two and takes less than 10 seconds. You can prove when it was written to avoid the charge of fudging the record. I don’t think any plaintiff’s attorney would be able to make much headway against that. Sure, it would be better to never have the artifact recorded in the first place, but to allow it to be erased would also allow the true value to be erased. This is the very problem created by the handwritten record. Credibility is lost. The only solution is to reduce the artifact rate. Now that we can measure the artifact rate, maybe those rates will be published for different monitors and we can buy monitors with lower artifact rates. This information has been available from EPRI. The monitoring industry will be motivated to improve that good rate and possibly produce a six-sigma monitor (3 failures in 1 million recordings).
Hopefully enough people will soon see that this worry about legal and artifact issues is worth the improved hypotension, hypoxia, tachycardia, hypertension, emesis, and cost of anesthesia or almost anything else one chooses to measure. My former department experienced those improvements from 1988 to 1996. As the saying goes, “If you don’t measure it, you can’t improve it.” That statement is not quite right either. What is more true is that if you do measure and report on an issue, your department will pay attention to that issue and, as a result, it almost assuredly will improve. Let’s help move off this legal issue by changing the terminology to CPRAs or ACRs. If we don’t, I predict we will have many more mock M&M panels and white papers in an attempt to correct the false impression created by that “A” word terminology. Will the APSF formally endorse another term for the technology? I think it will take a statement like this to change the history of using this incorrect and misleading term. This should be the first standard term dealt with in the dictionary. The term “Automated Record” is a poor alias or a term for a machine that has not yet been developed.
David W. Edsall, MD
Albany, New York
Disclaimer: David W. Edsall, MD does not have any financial relationship to any computerized anesthesia record manufacturer.