Peer review and privileging: one pill cures all--but it's tough to swallow.

It may be time for us to face reality and admit that peer review, and the resulting privileging process, is an environment rich with improvement opportunities in many hospitals. Probably the biggest challenge is that members of the medical staff increasingly, and perhaps justifiably in some markets, are reluctant to evaluate the quality of care delivered by their peers.

This attitude comes not only from professionalism regarding their colleagues, and the emotional fear of being next, but also reasonable concerns about the legal entanglements that can result from peer review activity.

More importantly, while perhaps not always espousing their positions succinctly or tactfully, many dedicated members of the medical staff understand that the current methodology of "one-chart-at a-time" is not serving its original purpose very well.

Well-done peer review should have two generic outcomes.

1. There should be an advancement of the baseline quality established by the medical staff, together with the board, toward excellence.

2. There should be maintenance of that baseline through elimination of individuals unable to meet minimum standards.

From the perspective of internal processes, peer review should feed information to others within the hospital of potential further investigation of system-wide performance improvement opportunities. Inadequate peer review misses the opportunity to consider standardization of processes, equipment, supplies and procedures that could elevate the minimum quality standards of the institution toward excellence.

The overly permissive peer review process--and inherently one that focuses on one-chart-at-a-time--rarely perceives the patterns of care from the individual, the team or the system that hold back the institution's march toward its goal of excellence. While the failure to eliminate a sub-par health care provider from a system could endanger tens or hundreds of patients per year, the inability to recognize a single system flaw could have implications on quality of care received by thousands of patients, and delivered by many physicians.

And in the rare instance where an individual physician's care to an individual patient is the problem, peer review should provide the information needed for the next step in addressing the appropriateness of privileges for that physician. But it is difficult to find a pattern of marginal care while reviewing mountains of individual charts for specific and unrelated issues on each chart.

Such one-chart-at-a-time peer review allows individuals with chronic but non-flagrant performance problems to escape the consequences of their outcomes, allows individuals with sub-standard patient care to continue their mediocre practices, endangering individual patients as well as the reputation of the institution and others who practice in that facility.

Conversely, overly aggressive peer review can stagnate the process itself, while unjustifiably impugning the integrity of an individual provider. Unpredictable adverse outcomes, multiple caregiver error, and even minor individual errors of omission or commission can appear in retrospect to be unacceptable breaches in the minimal standards of quality. (1)

In an era of publicly reported quality measures, and as yet still poorly documented co-morbid and coexisting conditions, a pattern of outcomes that is apparently below the average of peers can result in a physician's privileges being reviewed. The attention, time and energy given to the individual's performance could waste the valuable resources of dedicated members of the hospital and medical staff whose energies could be put to better use improving the system of care.

Legal implications

Both of these "off target" attempts at peer review have significant legal implications both initially and in the long term.

Overaggressive peer review can result in accusations of slander, libel, and conspiracy to eliminate competition. Even if an institution and its medical staff are successful in defending against such accusations, the process can be financially and emotionally draining.

When not successful, both the hospital board and the individuals on the medical staff who participated can sometimes face substantial individual financial burdens as most error-and-omission as well as malpractice insurance policies require good faith, best effort and due diligence on the part of the insured as a prerequisite for indemnification. Fraudulent actions are rarely if ever covered.

As long as these cases can take to resolve, this is truly only the beginning of the institution's and its medical staff's problems. Medical staffs confronted with the reality that such lawsuits can entangle them in years of legal proceedings--with the attendant loss of time from revenue-generating patient care--are reluctant to cast aspersions on their colleagues. Without local participation by their medical staffs institutions face the additional long-term complication of under-aggressive, meaningless or sham peer review.

In many states, the relevant medical malpractice acts include the oversight of the quality of care provided in an institution.

Institutions, their boards and their medical staffs who are shown to have allowed marginal and poor quality providers of care to continue functioning in their institutions incur liability for the actions of those individuals. To the extent that peer review, credentialing and privileging procedures continue to enjoy some protection from discovery in malpractice suits, extending liability to the institution is not often easy.

An emerging trend in this arena is notably dangerous for its ability to pierce such discovery protection. "Negligent credentialing" is enjoying focused attention by the plaintiffs' bar. The basic allegation against the individual physician for malpractice is accompanied by an accusation of negligence, potentially on the part of the hospital board, the medical executive committee and credentialing committee that granted privileges to the incident physician who allegedly engaged in malpractice.

Hospitals faced with a negligent credentialing suit, concurrent to a malpractice suit against an individual physician, have found it very difficult to defend against the accusation of negligence while simultaneously maintaining the confidentiality of the documents that might disprove the basis of the complaint.

Not surprisingly, some hospitals have attempted to demonstrate the integrity of their system with the production of policy and procedure manuals that describe their efforts to use the experience of the physicians on their medical staff as the basis for privileging decisions.

Also not shocking is that a description of "what we say we will do" (in policy and procedure manuals) has not reassured all judges and even fewer plaintiffs' attorneys that actual behavior in the hospital mimics the well-intentioned manuals the hospital's produce.

A hospital might also produce aggregated data of the volume of charts involved in it's quality monitoring process, referrals to departments for review and outcomes of review. For example, Diagram I depicts a common paper flow of peer review in U.S. hospitals. Table I describes peer review scoring codes similar to those used in many hospitals.

Table II represents 18 months of quality monitoring and peer review process from an academic medical center's eight busiest departments. Even a cursory review by a seasoned physician executive of the data suggests that there is a lack of consistency between departments in the process of quality monitoring and peer review. The next defense might be to demonstrate, in aggregate fashion, the outcomes of the process.

Table III provides the "final" outcome of the eight cases scored 3 or 4 from the same academic institution. In the suspicious eye of a plaintiff's attorney these data could be highly suggestive of a process serving to protect the very problems the system was designed to uncover. Even a reasonable judge might not be reassured that the peer review process is imbued with integrity and be obligated to continue proceedings on the question of negligence in the credentialing and privileging process.

One solution

Other industries have faced the problem of guaranteeing the integrity of quality monitoring and devised two systems to address the issues.

One system seems particularly difficult to transfer to health care, that of the simulant. A simulant serves to imitate or reproduce the essential features of something else.

In the manufacturing world, this might entail intentionally placing a defective product in a production, assembly or packaging line. The detection and removal of the defective product is evidence that the mechanisms designed to evaluate and monitor quality are working (be it people or computer-guided lasers searching for defects).

Simulants are also particularly useful in the chemical manufacturing industries where molecules can be designed that are similar enough to activate monitoring devices, while carrying no inherent toxicity. The release of a simulant into the atmosphere or into the local environment of a monitor, followed by alarms from the monitoring system, reassures that monitors are functioning well.

Simulating poor care, or even introducing documents into a chart that suggests error has its own legal problems, and providing mechanisms for meaningfully "blinding" the simulant placement from quality monitoring systems and chart reviewers has proven frustrating.

The second mechanism commonly used in other industries involves layers of redundancy. The strategy of redundant systems is not without its own problems. A quality monitoring system so dependent on human evaluation and judgment is encumbered by errors of both omission and commission. (2)

From a purely statistical approach, having multiple members of an institution's medical staff review the same chart could eventually be projected to alleviate most errors of omission. That is, we could dramatically reduce the probability of errors caused by haste, lack of specific expertise or unintentional failure to discover a problem.

But if we are to defend against accusations of intentional and sham peer review (i.e., errors in a "good ole boy system"), and if we are faced with having to present evidence in a legal proceeding that our peer review system is rigorous, unbiased and above reproach, then it may not be enough to ask a second, third or even fourth member of the same medical staff to review an individual chart. Similarly, accusations of intentional overaggressive peer review (in an antitrust case) may need to go a bit further in the design of our redundant system than simply adding layers of internal or local opinion.

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The purpose of redundancy in a quality review process is to reassure the public, through judicial review when necessary, that the process is unbiased and objective.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that institutions have a policy guiding referrals for external peer review. (3)

Many organizations have adopted very simple language that basically reflects the following: "External peer review will be sought whenever there is doubt concerning the ability to internally secure unbiased and objective review of the quality of care delivered." To date, hospitals have been unable to determine a better mechanism for providing this assurance than external peer review.

The "ideal" system

Based on the above comments and strategies used by industrial engineering, a redundant system involving external peer review might look something like Diagram II.

The internal peer review process would involve one or more layers of peer review by clinical department members and or the chief of the clinical service. At some point this internal or screening process would result in one of two decisions

* No further individual privileges action required (codes 1, 2, and perhaps 3 in our example)

* Further review for possible privileges change (certainly code 4 charts)

Prior to any recommendation for privilege changes, external review should be secured. Any disagreement about the need for external review between the board and medical executive committee should result in a default outside review.

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Depending on the outcome, the external review at this point in the process could provide:

* The basis for proceeding with recommendations and actions for privilege changes based on objective and unbiased review, and hence a defense against a later antitrust suit

* Reassurance to all that minimal standards of care have been delivered

A clear line defining focused review of a practitioner that would require reporting to the National Practitioner Data Bank (NPDB) should the investigated individual resign from the medical staff

This last benefit is significant, as the absence of a clear definition of what stage in the process constitutes a "professional review action that could result in adverse privileging" has caused many institutions to teeter dangerously on the decision to report to the NPDB. And failure to report has its own repercussion. (4)

Many hospitals implement this step with the external peer review of a single chart, or even a series of charts from a single physician. This provides little advantage to defend an accusation of prejudice on the part of the reviewer.

The ideal referral for external review would provide a package of 10 to 12 charts (three to four charts each from several physicians) with no communication whatsoever to the external reviewer of the problem physician or incidents that have raised concern.

An external review, blinded in this way, that raises serious doubts about the quality of care delivered by a particular physician is extremely difficult to ignore when a de-privileged physician's attorney considers proving in court an accusation of defamation, prejudice, bias or conspiracy to eliminate competition.

Returning to Diagram II, the internal review process can also result in findings of acceptable quality with no further action required. The intent is that no further action need be taken concerning the privileges of the physician. But there are several other actions that a hospital wishing to defend itself against accusations of negligent credentialing should take, and several actions that should be taken by a system oriented to performance improvement.

First, a review of the quality indicators and reasons for referral should be completed.

Have we requested that our medical staff review every death, every administration of a blood product, or any other broad category unfiltered by additional criteria, resulting in a waste of the physicians' time?

Have we referred so many charts to physicians for review that we are encouraging errors of omission by the sheer volume of cases to be reviewed?

A review of quality indicators, and the resulting chart review by physicians, should be a rich source of information for hospitals to modify the quality indicators that serve to identify charts for review. If "death" is an indicator, should we not discard from a quality review "expected deaths?"

We can still review a series of death charts to survey offerings of hospice care and do not resuscitate declaration, adequacy of pain relief and pastoral support, and many other measures of appropriateness of end of life care management. But this is very different than the review of a single death where the implied purpose is to evaluate the quality of care surrounding a patient's death.

Second, a truly random sampling of the charts reviewed internally by the medical staff, and found to be within the standards of acceptable care, should also be packaged and advanced for external review. As with review for problematic cases, the external reviewer should be blinded as to the purpose of the review and should provide a written report of the quality evidenced by the charts so reviewed.

Such a regular external review of the "no problem" cases should provide a powerful rebuttal to an accusation of negligent credentialing when combined with a summary of meaningful performance improvement interventions, adverse professional review actions and curtailment of privileges.

How can we afford this?

Physicians frequently embrace the concept of external review of problems as familiar. Practicing physicians already recognize the wisdom of viewing certain investigations as "screening tests" that require confirmation from a more specific test. Furthermore, securing and demonstrating fair treatment from external reviewers could easily involve the regular and routine referral of the "everything is OK" charts.

The most significant barrier to adopting this approach to validating the peer review system with external oversight usually comes from the CFO, because of the cost.

There are several strategies for minimizing the cost of external review. The most obvious is establishing networks of hospitals that agree to exchange charts needing external review. The risk of involvement in legal action is still real for physicians, but the process reduces that risk and provides a viable option to having professional review done by non-physicians.

Ultimately, the CFO and board see the strategy of external peer review as one of cost minimization instead of new costs. The failure to secure external review will place the institution and its staff at higher risk of an eventual suit for negligent credentialing or anti-trust and attendant costs.

Anti-trust typically consumes years to litigate and damage awards are automatically tripled. Libel, slander and negligent credentialing can ruin hospital and medical staff reputations. An ill-prepared hospital could be forced to respond to a negligent credentialing suit by setting a precedent for discoverability of peer review and other quality documents, and further inhibit physician participation in future peer review.

A further potential cost avoidance secured through the review of "everything is OK" charts is the defense of over-utilization investigations. Most hospital boards rely on their medical staffs to include inappropriate care as a part of the quality surveillance process.

Boards that rely solely on internal review could find it difficult to demonstrate that they did not know, nor should have known, about inappropriate or unnecessary care billed to third-party government payers. External review of the code 1 and 2 cases in our example could provide evidence for an institution that it took reasonable precautions to monitor for over-utilization.

Many hospitals, after reviewing the alternatives, have come to view a complete external review redundancy check as a cheap option. The best proponent of such a strategy may be the hospital attorney. Asked to choose, most would rather be defending boards bolstered by evidence from external review.

Richard Lauve, MD, MBA, CPE, FACPE, is a health care consultant based in Baton Rouge, La. He can be reached at 800-934-7354 or [e-mail].

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References

1. Cook R, Woods D and Miller C. "A Tale of Two Stories: Contrasting Views of Patient Safety; Report from a Workshop on Assembling the Scientific Basis for Progress on Patient Safety; National Health Care Safety Council of the National Patient Safety Foundation at the AMA." Available at http://www.npsf.org/exec/npsf_w97.doc.

2. Park K. "Human error. In: Salvendy G, ed." Handbook of human factors and ergonomics. New York: Wiley, 1997.

3. JCAHO Standard MS.4.90; Elements of Performance # 4; Hospital Accreditation Standards, 2006.

4. Kadlec Medical Center v Lakeview anesthesia and Associates, 2005 WL 1309153 (E.D.L.A)--Federal Court decision handed down May '05 may have profound effects on hospital's sensitivity toward reporting to the National Practitioner Data Bank.

By Richard Lauve, MD, MBA, CPE, FACPE

Table 1 Rating Codes

1. Screening indicator met, but clinical practice acceptable.
2. Questioned practice not necessarily routine, but not unacceptable. No
   adverse outcome or outcome unrelated to questioned practice.
3. Questioned practice unexpected. Adverse outcome may have been
   avoidable, or questioned practice needs further review.
4. Questioned practice unacceptable. Adverse outcome occurred, or is
   likely, if practice continues.

Table 2 Charts Reviewed Over 18 Months

                 Cases       Not
                 Meeting     Referred  Chairman  Not    Rated 1  Rated 3
Department       Indicators  Chairman  Review    Rated  or 2     or 4

Anesthesia        103           0       103        1    102      0
Cardiology        171         109        62        3     57      2
ER                641          97       544        0    544      0
Family Practice   181         178         3        2      1      0
General Surgery   339         197       142        9    129      4
Internal Med      681         656        25        1     24      0
OBGYN             208          35       173      156     16      1
Thoracic          143          66        77        3     73      1
  Surgery
Totals           2467        1338      1129      175    946      8

Table 3 Action Steps

1. Ongoing monitoring and reporting shall continue.
2. Importance of checking and documenting variances in refills restated.
3. No trends identified.
4. Recommendations tabled until additional data/information can be
   obtained.
5. All cases reviewed and addressed with involved CRNAs.