Protecting IVF laboratory staff from unfair litigation

As risk management moves from the manufacturing industry to healthcare there is a far greater - or at least more immediately obvious -impact of risk on customers' wellbeing. Although the underlying issue and driving force for risk management is patient safety, the increasing focus on financial risk, not just medical risk, has substantial implications for healthcare workers - and hence IVF Centers.

A leader in the medical application of RCA stresses that "Errors must be accepted as evidence of systems flaws, not character flaws" (Leape, 1997). But even if the professions involved all agree that adverse events are the result of happenstance, multiple human errors that combine in a particular configuration by chance (Reason, 1994; Bogner, 1994), a situation with extremely negative emotional impact could arise if the unfortunate, and unintentional, victims obtained an RCA report describing the "causes" of their problem - and litigation could ensue. Because personal liability is a far greater risk in healthcare than in industry, issues of personal fear are correspondingly more prominent.

In addition, some organizations operate under a management culture of fear, which further compounds employees' worries and increases the likelihood of errors being concealed, cover-ups organized and staff dishonesty in general. No Center should instruct its staff to conceal errors, or to lie to patients under threat of dismissal or other punishment. Such behavior is unacceptable. In a decent, supportive work environment, where risk management and Quality flourish, the following principles must guide all human resource activities (and be documented in all employees' contracts):

(a) no-one will be punished for making a mistake;

(b) mistakes are always seen as opportunities for improvement;

(c) if a mistake occurs it must be reported to the supervisor immediately and dealt with expeditiously;

(d) anyone who lies about a mistake or attempts to cover one up should be dismissed; and

(e) all levels of management must adhere to and apply these same principles.

Protection of employees from personal liability is essential if any modern-thinking IVF Center is to function without its staff living in permanent dread of litigation - a concern of everyone, not just clinical embryologists. To this end Centers must have fully-detailed standard operating procedures (SOPs) documented and in place, complemented by comprehensive quality management and risk management programs. Then, so long as staff work within this framework, the Center should have a legal (not just moral) obligation to indemnify its employees against personal responsibility for any adverse event that might occur, since it will have been a fault of the system. Naturally, in cases of mischief, dishonesty or blatant malpractice the Center's obligation would be nullified. Incompetence should also be the Center's responsibility since staff selection and training are the employer's responsibilities, and staffwho cannot perform any oftheir duties properly should not be allowed to continue performing them. Systems for continuous employee appraisal, proficiency evaluation and competence testing should be implemented by the employer, with both participation and satisfactory performance being mandatory.

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