DOH's Draft Mandatory Reporting Rules Raise Many Issues
Following the Institute of Medicine's reports of widespread medical errors in To Err Is Human (2000) and Crossing the Quality Chasm (2001), providers have implemented major initiatives to measure and enhance the quality of clinical care. A central underpinning of this effort has been a shift in organizational culture toward eliminating blame and shame in favor of identifying and adopting systemic changes to prevent errors. This cultural shift provided assurance to clinicians participating in organized quality improvement activities that their reports will be confidential and that they will not be punished for honest mistakes. Clinicians have responded with increased reporting of medical errors involving harm, no harm, or near miss events. Draft rules recently issued by the Department of Health ("DOH"), which mandate reporting of suspected unprofessional conduct or inability to practice with reasonable skill and safety, threaten to seriously undermine these efforts by imposing vague, confusing and often contradictory reporting requirements, with no assurance of confidentiality.

Background
In 2006, the Washington Legislature directed DOH to develop rules requiring health care providers who are regulated under Title 18 RCW to report convictions, determinations or findings that another licensed health care provider has committed unprofessional conduct. ⁱThe Legislature also specified that DOH "may" develop regulations requiring other persons or institutions to report formal findings that a licensee has committed unprofessional conduct or to report "information... indicating that the license holder may not be able to practice his or her profession with reasonable skill and safety to consumers as a result of a mental or physical condition."

DOH has recently posted revised draft rules that would impose mandatory reporting obligations on both license holders and health care institutions, including hospitals and ambulatory surgery centers. These proposed rules ⁱⁱraise a number of concerning issues. The purpose of this memo is to alert BB&L's healthcare provider clients to several key issues that appear to be problematic and to encourage you to comment on the draft rules.

The December 2007 Draft Rules

Who is reqired to report?
The proposed rules impose obligations on "license holders" and "health care institutions," as well as insurers, peer review groups and professional organizations. Our comments are limited to:

• License holders: license holders are persons issued a credential by one of the entities listed in the Uniform Disciplinary Act, Ch. 18.130 RCW. This definition includes all licensed or credentialed health care practitioners.
  
  
• Health care institutions: includes hospitals, ASC's, childbirth centers, chemical dependency treatment programs, nursing homes, drug treatment agencies, and mental health treatment agencies.
  
  
  Issues:
  
  
  • Cross-disciplinary reporting obligations: Any license holder is seemingly required to report any other license holder, regardless of the type of license held or the reporting person's ability to judge the competence of person being reported.
    
    
  • Duplicative reporting: The draft rules do not address circumstances where the reportable information is publicly known or may have been previously reported to DOH. Nor does it address the obligations of individual license holders where institutions or others with which they are affiliated may have a separate reporting obligation.

What must be reported?
For License Holders: License holders have two obligations:

• Self-reporting License holders must self-report: "any conviction, determination, or finding that he or she has committed unprofessional conduct or is unable to practice with reasonable skill and safety due to a mental or physical condition" or if they have been disqualified from the Medicaid or Medicaid programs.
  
  
• Reporting others: In addition to reporting convictions, determinations or findings of unprofessional conduct, all license holders are required to report when any other license holder who "may not be able to practice his or her profession with reasonable skill and safety due to a mental or physical condition."

For Health Care Institutions: License holders have two obligations:

• When a license holder's services are terminated or restricted because of "harm or unreasonable risk of harm to a patient;" or if
  
  
• "The institution believes a license holder poses an unreasonable risk for harm to patients or clients due to a mental or physical condition."
  
  
  Issues:
  "Vague, Circular, or Inconsistent Definitions:" It was expected that DOH's regulations would add specificity to the words of the statute. The draft rules are, however, often confusing and, in some instances, appear to be inconsistent with statutory requirements; e.g.
  
  
  • "Determination or finding:"Whereas the ordinary meaning of these terms would indicate some kind of formal process, the draft rules simply require a "decision" that a patient was harmed or "unreasonable risk of harm to a patient" has occurred, regardless of whether any action or sanction was taken against the provider. This language creates the potential for unnecessary or premature reports. For example, a physician who serves as an expert witness for plaintiff in a medical malpractice case might be required to file a report against the defendant-doctor, because the expert-license holder has "decided" that the defendant committed malpractice and thereby harmed a patient.
    
    
  • "Conviction:" The draft definition (i.e., any gross misdemeanor or felony) arguably goes beyond the statutory definition of convictions amounting to unprofessional conduct. RCW 18.130.180(1) states that a conviction of a crime involving moral turpitude, dishonesty, or corruption relating to the practice of the person's profession constitutes conclusive evidence of unprofessional conduct. The draft rules would seemingly require reporting of criminal matters not relating to a provider's professional activities or otherwise bearing on character and fitness to practice.
    
    
  • "Unable to practice with reasonable skill and safety:" The draft rules define this phrase to mean either a court-finding that the license holder is incompetent or mentally ill (which would also amount to a "finding or determination") or that the license holder "is not successfully managing a mental or physical condition and is reasonably likely to cause harm." The draft rules do not define "mental or physical condition," so providers must speculate as to whether the term includes things such as the effects of aging. The concept of "successful management" is also left undefined, so that each person or entity with a reporting obligation is left to decide what constitutes success.
    
    
  • "Harm or unreasonable risk of harm to patients:" The draft rules fail to provide guidance as to what constitutes "unreasonable risk of harm to a patient" and, because there is no "finding or determination" requirement associated with this provision, subjective beliefs could trigger a report. In addition, the language describing this reporting obligation differs between license holders, peer review committees, QI committees and PRO's ("actual knowledge") and health care institutions ("the institution believes"). There is no apparent reason for these disparities.
    
    
  • "Disconnect in requirements of peer review reporting:" State law (RCW 18.130.070) does not require an entity with a peer review committee or a member of that committee to report unprofessional conduct while the "investigative phase" of the committee's work is ongoing. The draft rules provide no guidance relative to when the "investigative phase" has concluded, however. Further, the draft language is unclear as to whether a member of a peer review committee who individually decides that a license holder has committed unprofessional conduct must report to the department when the peer review committee as a whole does not make such a determination or finding.

How do these obligations "fit" with existing requirements?

• Credentialing: Hospitals already have reporting obligations with respect to restrictions on privileges (RCW 70.41.210). Fortunately, the Legislature has provided that, that if a hospital has reported restrictions on credentials, a separate disciplinary report is not required. RCW 18.130.070(1)(c). The law also provides that peer review and QI committees, and their members, are not required to make reports while in the "investigative phase" of their proceedings. RCW 18.130.070(1)(d)(i). These accommodations are adequately reflected in the draft regulations, albeit with the issues previously noted.
  
  
• Adverse Events: The mandatory reporting statute and draft rules do not reference or incorporate the adverse event reporting requirements of Ch. 70.56 and WAC 246-320-145. Because the triggering events for adverse event reports are very different than what is proposed with respect to disciplinary reports, the new proposed disciplinary reporting requirements will be in addition to, and separate from adverse event reporting. Also of note, Governor Gregoire has proposed that adverse event reports should become public information. Such a requirement will create an incentive for hospitals or other facilities subject to adverse event reporting to conclude that licensed professionals should be reported, in order to avoid bad press or shift blame-and potential liability-if an incident receives further publicity.
  
  
• Sentinel Events: The Joint Commission requires hospitals to conduct a root cause analysis within 45 days of a sentinel event, i.e. "an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof." Unless a sentinel event also constitutes an adverse event, there is no current requirement for reporting to DOH. Under the draft rules, however, if a hospital concludes through its root cause analysis that the event may have been the result of unprofessional conduct or a license holder's inability to practice with reasonable skill and safety due to a mental or physical condition, it appears that a report to disciplinary authorities will be required.
  
  
• Federally Funded Substance Abuse Treatment Programs: Federal law provides that employees of a federal funded substance abuse treatment program must not identify any individual seeking treatment at the program facility. See 42 CFR Part 2. The draft rules obligate a license holder employed by such a program to report another license holder/program patient if he or she "pose[s] a clear and present danger to patients or clients," and impose an unqualified obligation to report on the CEO of such a program - thereby placing the program and its employees at risk of violating federal law. ⁱⁱⁱ
  
  
• National Practitioner Data Bank ("NPDB") Reports: The obligation to report to disciplinary authorities would not be satisfied by reports to the NPDB.

What is going to happen and what can I do about it?
DOH's December 2007 draft rules, posted on December 14th, represent the Department's third attempt at informal rule development. The most recent draft, together with provider comments on the earlier drafts, make it apparent that DOH is having great difficulty developing clear and workable rules that will meaningfully improve public safety.

One of the unintended consequences of the Department's increased emphasis on health professions discipline is that the system becomes buried in useless, redundant or confusing information. The draft mandatory reporting rules, because they are so vague and confusing, heighten that risk.

Nonetheless, DOH is under a legislative mandate to get rules in place and, based on the timeline on its website, it appears that the Department is prepared to move to the formal rule-making stage based on the December 2007 draft (discussed above), with the goal of adopting final rules in early spring 2007.

Comments may be submitted to DOH on-line at: www.doh.wa.gov

Click "Comment on Draft Rules." Through their professional associations, providers also can continue to press the DOH to refine the rules.

As the rules begin to take final shape, providers and professional associations will need to provide education to their staff and membership about their requirements.

We will provide additional information about the rules when they are finalized. In the meanwhile, for further information about the rules, or advice on implementing the rules and related training programs, please contact: Mike Madden, Terri Rambosek or Laura Dunlop of our firm, at 206-622-5511.

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ⁱ RCW 18.130.070, enacted by c. 99, § 2, l. 2006 and amended, effective July 1, 2009, by c. 273, § 23, l. 2007.

ⁱⁱ Available at www.doh.wa.gov/hsqa/hpqa/HPQAManRep/html/draftrule122007.htm

ⁱⁱⁱ The new rules also appear to eliminate the opportunity for confidential treatment and monitoring of impaired professionals.