Right Touch Regulation and a Preliminary Competence Inquiry

As defined by the Professional Standards Authority, right touch regulation is proportionate, consistent, targeted, transparent, accountable, and agile.1 Regulation of medicine has always existed to some degree and historically it was considered the prerogative of the profession to self-regulate to assure competence of individual practitioners. The intervention of the state as the regulator is a relatively recent occurrence and has accelerated in some jurisdictions. In the United Kingdom (UK), sequential cases of failure in self-regulation have been revealed; investigations into pediatric cardiac surgery at Royal Bristol Infirmary of 1998,2 the Shipman inquiry of 2000,3 the Alder Hay Hospital retention of human tissue reported in 2001,4 the Kerr Haslam report of 2005 of sexual exploitation of patients by psychiatrists,5 and the 2008 report into Stafford Hospital mortality rates. In Australia, deaths at Bundaberg Hospital demonstrated that concerns over effectiveness of medical regulation were not limited to the UK.6 Canadian anesthetist George Doodnaught was found guilty in 2014 of sexually assaulting more than 20 women undergoing surgery despite four colleagues being aware of complaints that suggested such assaults were occurring.7 Tenet Healthcare in the United States has been indicted for $400 million in fraudulent charges to Medicaid as well as $12 million in bribes and illegal inducements.8 Failure to report a colleague's poor performance or significant health concerns are well known and represents a common theme in failure of professional self-regulation. In the United States, disgraced pediatrician Earl Bradley was found guilty of multiple counts of child sexual abuse of his patients. Although his arrest occurred in 2009, there had been eight allegations of improper behavior made in the previous 14 years, none of which resulted in adequate investigation.9 In New Zealand, the Cartwright Inquiry of 1988 and the Gisborne Cervical Screening Inquiry of 2000 both drew attention to problems in medical regulation.10,11 Commenting on the report on the Royal Bristol Infirmary, the editorial of the British Medical Journal was appropriately titled “All changed, changed utterly.”12 

While new concepts were developed to regulate the medical profession, these were not without distractors. In particular, the debate on what was being regulated, people or behavior, became prominent. The practice of regulating people assumed that once a practitioner was deemed trustworthy, they could be trusted to demonstrate the right behavior. Measuring the values of a professional immediately became problematic. The practice of regulating behavior was more attractive as an option, as metrics could be applied. However, this approach came at a cost where physicians felt scrutinized — and not trusted, as noted by Nick Brown and Dinesh Bhugra: “Under the banner of public safety, increasingly draconian ‘external’ control has been imposed upon doctors.”13 

New Zealand has about 15,000 practicing physicians, of which just more than 4,000 are general practitioners (family physicians). There is an extensive system of public hospitals that provide secondary care free of charge and salary their physicians. Waiting lists at public hospitals for elective care can be long. Private care is available and about 30% of New Zealanders will pay for health care insurance as well as having access to publicly funded care. Most physicians providing private care are self-employed. Most general practitioners are self-employed but there is a strong trend towards employment models. General practice services are heavily subsidized by the government through umbrella organizations called Primary Health Organizations (PHOs), which also take responsibility for quality of care. Competence issues can be managed at a variety of levels; minor issues may be dealt with at an individual hospital, group or PHO depending on the ability to investigate and manage such problems, while more substantive concerns are referred to the regulator.

In New Zealand, the regulator is the Medical Council of New Zealand (Council), which has powers mandated by the Health Practitioners Competence Assurance Act. The Council conducts performance assessments of physicians in which concerns over competence have been raised. A Performance Assessment Committee (PAC) consists of two medical members (peers) and one lay member who observe a physician's practice for one to two days in their own place of work. Historically, the number of such assessments has averaged about 40 per year for the physicians on the register who are also practicing. The results of such assessments are divided into one of three decisions: Category 1 — satisfactory performance, no substantive concerns found; Category 2 — some concerns found that require remediation (either self-directed, or with a Council-appointed mentor or supervisor); and Category 3 — global concerns found that require remediation (with a Council-appointed supervisor) and/or restrictions placed on the physician's scope. The assessment process has been previously described.14 

An increase in the number of assessments being ordered, coupled with more than half the assessments being rated as Category 1 “satisfactory performance, no substantive concerns,” led the Council to reconsider the approach to ordering an assessment of competence. In particular, it was felt that a lack of broad information about the physician when concerns were initially raised was leading the Council to take a cautious approach and require a formal assessment when further information may have been reassuring. The Preliminary Competence Inquiry (PCI) was designed as the method of obtaining this information.

All complaints to the Council are initially routed through the Complaints Triage Team (CTT). At this stage, a decision can be made to take no further action, issue an educational letter, refer to a full Council meeting for consideration of a performance assessment (and other actions), or request that the physician undertake a PCI. A PCI is triggered when the CTT or Council believe that further information would better inform the decision about whether or not a full performance assessment is required. While Council can request a PCI, the vast majority are requested by the CTT. The PCI option is available for all physicians irrespective of where they work or who the employer is. This includes self-employed, or salaried physicians in both the public and private systems. With the PCI, a Council agent visits and interviews the physician concerned. The agent is a peer from the same or similar vocational scope (area of specialist practice) as the physician. The Council agent uses set interview questions and has a copy of the original concern and the physician's response to the concern. The interview does not investigate the initial concern but does cover the following areas:

• Education or professional development activities

• Professional support and associations

• Distracters or stressors on the physician's practice

• Use of practice systems including follow up and referral systems

• Clinical notes for the purpose of exploring practice systems and, where relevant, identifying any changes to practice since the matter referred/complained of

• Working environment

• General strengths and weaknesses

• Mental/physical/cognitive health concerns

• Changes in practice since the incident that led to the PCI

The Council agent is asked to write a report outlining the agent's findings but not making any conclusions on whether the practitioner meets the required standard of competence. Once received, the report is reviewed by one of Council's medical advisers for internal consistency and adequacy of detail. The agent is advised of concerns, if any, and provided with the opportunity to revise the report. The physician undergoing the PCI process has an opportunity to review and comment on any report prepared by the Council agent, prior to it being considered by the CTT and Council. The report is confidential and is not available to any outside body or to any subsequent PAC process. Unlike a performance assessment, the PCI is not a mandatory process; the physician is invited to participate but may decline. If the physician declines to undertake a PCI, the complaint information and any response is considered by the Council regarding whether any further action is required (without the benefit of the additional PCI information). A comparison between the PCI process and the PAC process is provided in Table 1. This paper discusses the results of 43 PCIs that were requested from 2011 to 2017.

Data on outcomes of all 43 PCIs that were requested between 2011 and 2017 were collected. Feedback forms from agents of the Council who had conducted the interviews were collated. Costs of the PCI process were calculated and aggregated.

Of the 43 PCIs requested, 26 (60%) were for physicians with a primary qualification from New Zealand and eight from other countries (Germany, Scotland, Fiji, Norway, Hungary, China, South Africa, the UK, Nigeria, Australia and India). The percent of physicians who held a current practicing certificate as of June 30, 2017, with a primary qualification from New Zealand is 58%. The age range for physicians undertaking a PCI was from 35–83 years old. The average age of the physician at the time the PCI was completed was 57. Of the 43 physicians requested to undertake a PCI, 13 were female (30%). The average time period to undertake a PCI from time of request to day of interview was 88 days. Nine physicians (21%) held a general scope of practice (no formal recognized post-graduate medical qualification) in comparison to 27% of all registered physicians holding a general scope.

The majority of physicians were working in the scope of general practice/family medicine (36, or 84%) of whom 26 were vocationally registered in the scope of general practice. Three were vocationally trained and registered in internal medicine, one in otolaryngology, one in sport and exercise medicine and one in pathology.

The nature of the concerns that led to a PCI request being made have been placed into categories. Multiple concerns were noted in 20 (47%) of the 43 physicians. The most prevalent concerns include communication, record keeping, prescribing, follow up and treatment.

Of the PCIs ordered, outcomes were available for 35 of the physicians, and 76% resulted in either no further action or in low-level remediation (educational letter or recertification program). One physician went forward for a full assessment as well as referral to a Professional Conduct Committee for prescribing inappropriately. This data is presented in Table 2.

If a physician who has undergone a PCI is required by the Council to undertake a performance assessment, the PCI report is not provided to the PAC. This is because the PCI report is used as a tool to guide the CTT and the Council's decision-making process.

Of the three physicians who declined to undertake a PCI following the CTT's request, the Council resolved that one physician was required to undergo a performance assessment, one physician was sent an educational letter, and one physician was subject to no further action.

Six performance assessments were ordered by the Council because of information revealed by a PCI. The outcome of one is not yet available. Of the remaining five, one resulted in a Category 1 outcome (no concerns over competence) and four were Category 2 (remediation required in certain areas).

A PCI costs approximately $1,700 (New Zealand dollars) whereas a full performance assessment costs approximately $12,000. The performance process is more expensive should the physician undergo a PCI then be required to have a performance assessment. But is significantly less if only a PCI is undertaken but a full performance assessment would have been ordered if there had not been the additional information available to the Council.

A survey was conducted among physicians acting as an agent of the Council and undertaking the reviews. The feedback from these physicians was positive. Three questions were posed in the feedback form:

• Do you feel the process allowed you to gather additional information that otherwise would not have been available to the Council?

• Are there any risks in the process, for example, did you find it difficult not being able to make conclusions in your report?

• Did the interview gain information that accurately reflected the physician's practice? (If no, why?)

Assessors felt that the process gave insight into the workplace as well as feedback on communication and attitudes. The informal nature of the interaction was considered to be a major advantage:

A change in practice environment between the time of notification of concerns and the PCI can potentially produce misleading information. There is also risk in the informal nature of the PCI, during which the physician being interviewed may regard the reviewer as an advocate rather than an assessor.

Overall, feedback from the survey indicated that the process generated accurate information.

The demographic data presented in this paper about physicians with concerns over competence echoes previous research on risk profiles. The mean age of 57 may well reflect that age is a risk factor for complaints.15 Similarly, it is not surprising to find a preponderance of male physicians in this sample, as male gender is also a recognized risk factor for complaints.16 

A financial consideration impacting the institution of the PCI process is that it is likely to reduce overall expenditure by reducing the number of unnecessary formal performance-assessments. The difference in cost between a PCI and a performance assessment is substantial. For the cohort in this study population, it is possible that up to 29 performance assessments were avoided, with savings of approximately $300,000.

Physicians who are subject to complaint almost inevitably find the process stressful. Investigation by the regulator is part of this stress. Research has found that the response of physicians can be a feeling of shame, alienation from patients and defensive medicine.17 The duration of proceedings is also one of the most stressful parts of a complaint.18 The set-up time for a PCI (88 days) is less than a performance assessment (about 260 days) because the logistics of a single visitor is less complex than three reviewers; and where formal terms of reference do not need to be negotiated with the physician. Further, the process is less intimidating as it only collects information (rather than observing consultations and the physician's wider practice) and the interview is completed by a single peer.

It is likely that a number of formal assessments of competence have been avoided by having a PCI process. Further, for those physicians where concerns were confirmed by the PCI process, a significant majority were found to have competence concerns at formal assessment of competence. The PCI process would appear to act as a filter — more accurately identifying those with competence concerns and those who are practicing with an acceptable level of competence.

A limitation on the usefulness of a PCI is that it is dependent on the physician being in the same work situation as when the sentinel event or events occurred. The workplace is an important determinant of the performance of a physician. In one of the 43 cases detailed here, the PCI occurred in a different workplace, which the physician had moved to after the complaint(s). The PCI found no major competence issues. A further shift in workplace occurred and more complaints were forthcoming. A subsequent performance assessment found substantial issues.

The PCI may also find unexpected issues. The notes-review for one physician revealed worrying patterns of prescribing of anabolic steroid as well as masking agents. A subsequent performance assessment and Professional Conduct Committee investigation confirmed this.

The data showing that only a third of physicians had a subsequent performance assessment would indicate that the extra information provided to the Council clarified issues and was reassuring to the Council about the competence of the physician who was interviewed. This meets the primary purpose of Council, which is to protect the public as well as demonstrating commitment to right touch regulation.

A Preliminary Competency Inquiry can reduce the number of full assessments ordered by the regulator when there are concerns over the competence of a physician. The structure of the interview is critical to success.