The law of unintended consequences: The joint commission regulations and the digital rectal examination

Study objective: The Joint Commission (TJC) recently issued stringent regulations about quality control testing of waived laboratory tests. Many hospitals subsequently instituted detailed procedures for performing, evaluating, documenting, and tracking point-of-care testing for fecal occult blood testing. We hypothesize that implementing this policy would generate an "opportunity cost" because busy physicians would need to compensate for this additional time required by reducing the frequency of digital rectal examinations or fecal occult blood testing. Methods: We designed a before/after study to measure use of digital rectal examination and fecal occult blood testing in a single-center study between 2002 and 2003. The experimental intervention was implementation of TJC-based hospital policy requiring physicians to manually document fecal occult blood testing quality control data. Charts were screened for 6 a priori established index diagnoses: abdominal pain, gastrointestinal bleeding, chest pain, constipation, diarrhea, and syncope/presyncope. Trained data extractors recorded the presence or absence of digital rectal examination and fecal occult blood testing by using explicit medical record review methods, and rates of both digital rectal examination and fecal occult blood testing were calculated. Results: We screened 3,337 charts and 788 met our inclusion criteria. For the primary outcome, physicians performed 16.7% fewer digital rectal examinations after implementation of the policy (41.3% versus 24.6%). Fecal occult blood testing decreased by 18.7% (38.5% versus 19.8%). Conclusion: TJC-inspired point-of-care testing policy was negatively and unintentionally associated with physician examinations, most notably the performance of a digital rectal examination. Institutional regulations designed for patient safety may unintentionally influence patient care. Economists describe this paradoxic phenomenon as the Law of Unintended Consequences. The costs and benefits of such policies should be analyzed before implementation and enforcement of new medical regulations.