Critical Care Medicine - List
http://www.pitt.edu/~crippen/

CASE#11: Peer Review Inquisition

A 79 year old woman with a history of extensive COPD is admitted to the ICU fluid overloaded and in apparent renal failure. Her CXR is compatible with moderately severe COPD and pulmonary edema. Her BUN is 100 and her creatinine 6.9. A dialysis catheter is placed and 30 minutes into dialysis, she is noted to become hypotensive but responds to fluid challenge. EKG is noncommittal and cardiac enzymes are pending. Her urine output is nil. Ultrasound of the kidneys does not show obstruction. Her lab values are mostly noncontributory, but her PT is mildly elevated at 14.9 with a normal PTT. You feel you need more guidance in dealing with her hemodynamic problems.

You are performing a pulmonary artery catheter insertion through the right internal jugular approach which proceeds smoothly until the balloon is inflated to measure a PWP and you are greeted with a gush of blood from the patients mouth. She is immediately intubated and blood continues through the endotracheal tube. FFP, Cryo are immediately ordered. Stat CXR shows a complete white out of the right side. Blood flow continues unabated from the endotracheal tube despite aggressive measures, the patient becomes hypotensive, bradycardic and dies.

One month later the following letter is seen reposing in your mailbox:

Dear Doctor (fill in your name here):

In accordance with it's Federal contract, the Acme Peer Review Organization is responsible for review of health care services delivered to Medicare beneficiaries. All cases subject to retrospective review by our organization have quality generic screening elements applied by trained personnel. When a case fails one or more screens, it is considered to be an indication of a potential adverse occurrence. The case is then referred to a quality review physician specialist for review. The medical record of your patient was included as part of this quality review process and the following concerns have been identified:

"The patient ruptured a major blood vessel in her lung during a procedure performed by you, resulting in death. This is not an expected complication of the procedure".

This letter serves as notification of these preliminary findings and we recommend that you provide a response. This is your sole opportunity to provide a response as there are no reconsiderations/appeal mechanisms afforded in the quality review process.

Sincerely,

You respond by sending a letter to the Acme Peer Review Organization describing the indications for and details of the procedure. You also include several references describing this complication. About a month later another letter from Acme graces your mailbox:

Dear (fill in your name here):

The Acme Peer Review Organization has received additional information from you regarding case # 3764 and has been reviewed by a Acme physician specialist. It has been determined that quality of care concerns remain. Those specific concerns are as follows:

"The patient should not have undergone placement of a pulmonary artery catheter. The situation was not emergent. There was no hypotension at the time of placement. The patient could have been managed more conservatively. In addition, the patient's clotting factors were elevated making this invasive procedure extremely dangerous". The fact that the blood vessel ruptured during balloon inflation is presumptive evidence that the procedure was performed negligently".

Since a quality of care concern remains, it is recommended that all of your medical charts be reviewed by an Acme representative for a period of one year, and that you attend, at your own expense, a continuing education course in which cardiopulmonary procedures are highlighted. This meeting will be specified by Acme sometime during the next six months. Please note that this/these actions does/do not preclude possible further interventions as may be deemed necessary by the Acme Peer Review Organization.

You have the right to meet with a panel of experts selected by the Acme Peer Review Organization to further review this case. It is also your right to have an attorney attend this meeting with you and an attorney for Acme will attend also. If you choose to convene such a meeting, final determination of sanctions against you will be deferred until after the panel's review.

Sincerely,

Your attorney says she'll accept a $5000.00 retainer for services during the appeal and beyond. Do you really want to fight a war of attrition with these people?

• From Crippen: THE PLOT THICKENS. You've done nothing negligent. You elect to send the Acme Peer Review Organization a nasty letter, in essence telling them they don't know what they're talking about. You go into great detail about the indications for pulmonary artery catheterization in unstable hemodynamics regardless of the vital signs at one moment in time. You mention that an isolated PT of 14.9 is not a contraindication and the only real problem might be increased bleeding at the site of puncture, easily controllable by direct pressure. The complication of pulmonary artery pressure has been reviewed in the literature and you supply the appropriate cites. There's no evidence at all of negligence, there is only a complication borne of a calculated risk that was reasonable in the face of projected benefit. The opinions of Acme's panel are no more grounded than the opinions of you and the expert who supports your position. You make the statement: "Acme cannot make accurate judgments of events in which they did not participate and have only retrospective evidence to support". No convincing evidence of negligence has been presented, I see no reason why I should be bound by decisions of this regulating body. Two weeks later, the following registered letter graces your mailbox:

  Dear (fill in your name),

  This notice is to inform you that Acme Peer Review Organization for (your State) has concluded that there is a reasonable basis for determining that you have violated your obligation to assure that the services provided to Medicare beneficiaries are of a quality that meets professionally recognized standards of health care. The Acme Peer review Organization Board of Directors recommend that (your State) Board of Medicine review the practice patterns of (you). This recommendation is due to the serious concern regarding quality of care rendered by (you) and the potential risk of harm to other patients.

  This recommendation is a result of the review performed by a panel of specialists consisting of two cardiologists and one family practitioner, all of whom are Board certified in their specialties. Because of the serious nature of a final determination of Acme to recommend a negative sanction against you to the (your State's) Inspector General. Sanctions can be, but are not limited to one to five years prohibition from treating Medicare patients. It is recommended that you meet with a panel of specialists selected by the Acme Peer review Organization.

  This will be your only opportunity to discuss your situation with Acme before a final decision whether to recommend to the OIG that you be sanctioned. It is your right to have an attorney attend this meeting. If you choose to do so, an attorney from Acme will attend also.

  Sincerely......

  Accordingly, you file a request for a meeting with Acme Peer Review Organization panel of physician specialists. You are notified that you(and your attorney) must proceed at your own expense to a major city 300 miles from your place of residence on the date specified. On arrival, you find that three physicians are waiting to discuss your situation. A cardiologist, an internist and an emergency physician. You are reintroduced to them only by name, and you are told that they do not have to provide you with any credentials specifying their expertise. You surmise that they have been recruited from the local community hospital and have no strong academic credentials. You bring with you a letter from a cardiologist (Board certified) from your institution supporting your position., It is entered into evidence. They listen patiently to your story for about 45 minutes, ask a few questions and the meeting ends on a noncommittal note. One week later you receive the following registered letter:

  Dear (fill in your name),

  Following your meeting, the panel determined that a sanction recommendation not be forwarded to the State Office of Inspector General at this time. However, quality concerns remain. The panel recommends that you submit a written corrective action plan involving a preceptor component.

  The preceptor should be a Board certified cardiologist who will oversee each and every placement of pulmonary artery catheter performed by you, either as a primary provider or an assistant for a period of one year. The panel also recommends that you attend, at your own expense, TWO continuing education meetings involving the placement of invasive diagnostic and treatment tools, to be specified by Acme.

  If this written plan of corrective action is not received by Acme within two weeks, the State Office of Inspector General will be notified as to your activities.

  Sincerely.....

  Your attorney informs you that the clock continues to tick on your $5000.00 retainer and wishes to know if you desire to continue the appeal at a higher level. You're still working on the first five grand....why not give a shot at another appeal?

• Crippen again: Peer review attempts to use a ponderous bureaucratic dialectic to evaluate physician manpower for clinical appropriateness and quality of care. Since any PRO must wait for medical care to be completed before passing judgment on quality of care issues, it must inspect completed medical records as a utilization reviewer rather than evaluate ongoing medical care. These are not synonymous concepts. There is serious question that true quality of care can be accurately assessed by retrospective chart review for at least two reasons. 1) The entire decision making process which goes into patient care, especially in difficult and complex situations cannot be adequately translated into written form. Some form of "translation" of the written thought processes is required, and this process varies widely with each physician to express himself in written communicative forms. Poor communicators do not necessarily produce poor health care. 2) Retrospective review puts the reviewer in a position of knowing the outcome of a given scenario before the physician writing the progress note. This admits a significant bias against the physician being reviewed into the review process which predisposes the reviewer to make quality of care judgments after the fact which were not known at the time of care by the physician. Despite these shortcomings, PRO makes legally binding assessments regarding quality of care on the basis of chart review, and enforces these judgments. This case is a composite of real facts. The individuals involved have quickly learned to fear rather than respect Professional Peer Review, such as it is.

  When an individual physician enters the pipeline, the burden of proof as to guilt or innocence is borne by the physician. It's (was) a surprise to find out that the PRO does not have to offer any demonstrable proof of their position other than expert testimony on their side and they cannot be sued. (At least they couldn't be sued as of 1990 when this composite occurred). The PRO does not have to prove an individual position is guilty, the individual physician has to prove they're innocent. PRO merely has to find an expert somewhere to support their position. In the event of dueling experts, the PRO expert always prevails. Most of the checks and balances which protect relatively powerless individuals against the overwhelming forces of the federal bureaucracy function within the PRO review process itself. If individuals choose to go outside this process, the overwhelming disadvantage of having to deal with a ponderous and expensive legal system embodying a built in government advantage provides little chance of an impartial appraisal. In addition, Those involved in this composite case found that the punishment for infractions escalated each time the system was bucked. Physicians who break the rules for whatever reason soon find out that the PRO can bring aggressive pressure to bear on recalcitrants, including precipitating investigations by State medical licensing boards and Inspector Generals offices.

  Such investigations may not be justified by factual evidence but once begun, there is a strong incentive for them to find questionable activities to justify their function in the regulatory bureaucracy; they can usually find something amiss if they look hard enough. Those who resist sanctions can be effectively harassed into silence by a regulatory system which has no effective avenue of redress outside the PRO. Tim Buckley suggested popping the lid off the PRO process and letting the sun shine in. This is strictly illegal. All proceedings involving individual physicians and PRO are confidential. Any forays outside the system are also met with negative sanctions. This is only logical. If you were going to design a punitive system to identify and punish physicians who run afoul of the rules, clearly such a system would always be adversarial in nature. Therefore, like IRS policies, no realistic appeal could be allowed since each and every victim would appeal, wasting the PRO's time. Instead, you would build into the system an "internal" appeal; appealing to the same judges that sentenced you, and you would allow the victim to wear himself down by a legal war of attrition he could never win, even if he could afford the legal fees. Organizations such as PRO's look at quality of care in terms of a set of rules, which if followed to the letter theoretically results in the most benefit for the greatest number. They formulate a "golden mean", which objectively translates into good care if complied with, then maintain this care by suppressing deviations from the mean. However, there is great deal of question whether rigid rules of standards necessarily results in quality care in all cases.

  Problems begin when deviations from the mean are appropriate and necessary for good patient care on the frontiers of medicine where there are few reliable guidelines or standing rules. The debate ultimately ends up as whether a deviation from the appropriate rule for treating "most" of the population can be beneficial for a select subset of population for which it doesn't apply. By and large, physicians who run afoul of the rules are sanctioned because of rule violation, not because of the reasons for rules violations. The best patient care sometimes is brought about by calculated risk taking, propositions guaranteed to be questioned by golden mean rules makers. By avoiding controversial issues, beneficial treatment is avoided as well as inappropriate ones. In this respect, PRO's have a capacity to formulate rules which promote mediocrity, then enforce them, a frightening vision of what all medical practice will look like in the future.

• From Crippen: David Swedlow sez: However, I think I missed the point. What was the editorial in reference to? sez: Haw! There doesn't have to be a point to any of my stuff ;-).You've never witnessed me go into a straight gonzo mode, like I would if someone suckered me into getting started on emergency rooms. Leave you stunned and shuddering, like a hound dog passing a peach pit. In fact there is a point to this. I wanted to leave you with a truly frightening scene. You....identified as a deviant by an organization who has a strong incentive to issue negative sanctions, has little incentive to look at your side of the issue, is not required to prove their allegations and cannot be sued if they make a mistake. This case is a real composite suffered by real people who are truly frightened of what PRO can do to them and how little responsibility they (PROs) have to assume. Anyone that I know who has come up against them are convinced that PRO "physicians" have about as much to do with working docs as IRS auditors have to do with taxpayers. They are a federal organization who have competed for a contract to identify physicians whose behavior falls outside of means established outside of means established by working docs.

  Whether or not behavior deviating from these means really indicates incompetence is an iffy proposition. I do not believe that the PRO system can identify incompetence any better than federal welfare bureaucrats can identify persons in need of assistance. Begs the question...how do we as physicians effectively ride herd on ourselves? If the PRO cannot effectively do it by arbitrarily establishing golden means and enforcing them in an inflexible and capricious manner, is it possible for any organization to do it? I don't know the answer to that. There clearly is such a thing as malpractice. I don't know of any watchdog group that has ever been able to do much about it. If any group tries, they are targets for immediate lawsuit by the same physicians who grouse the loudest about a legal system full of unrestrained litigation. If any watchdog group is insulated from legal accountability, they have the propensity to turn into Star Chambers. What is the answer? How do physicians in other countries than the USA accomplish this goal?