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Protocol is the detailed plan of a scientific or medical experiment, treatment, or procedure. Hospitals use all sorts of protocol, from how to register a patient to how a surgery is performed. Protocol ensures that processes are not only systematic but also efficient. So again, do protocols fail? They might if the protocol isn't detailed enough and if steps are missed. But if all steps and details are included, why would it fail? Human hubris.  

At MD Anderson Cancer Center, a 23-year-old patient died after receiving a blood transfusion tainted with a bacterial infection. The Center for Medicare and Medicaid Services completed an on-site inspection and issued a report claiming MD Anderson violated crucial hospital requirements. As a consequence, MD Anderson will now face stricter government oversight until these challenges are resolved.

The essential question is, “How did this happen?” CMS found major shortcomings in nursing services, pathology services, patient information, consents, and oversight responsibility. MD Anderson could have prevented these failures by following protocol. Following protocol is essential to healthcare compliance, and once one link in the protocol chain is broken or compromised, crises and tragedies will happen. It’s not a question of "if" but "when."

The Office of Inspector General provides important guidelines that help hospitals develop effective compliance programs. The OIG established benchmarks for the development and distribution of written standards of conduct, as well as written policies and procedures that promote the hospital’s commitment to compliance (e.g., by including adherence to compliance as an element in evaluating managers and employees).

Effective hospital protocol should include the following:

  • policies and procedures should identify specific areas of risk to the hospital under the supervision of the chief compliance officer and compliance committee 
  • standard of conduct
  • risk areas
  • claim development and submission process
  • medical necessity (reasonable and necessary services)
  • anti-kickback and self-referral
  • credit balance
  • retention of records
  • compliance as an element of a performance plan

As a result of this incident, MD Anderson instituted a new protocol called the “hemoviligence unit.” This unit will provide up to date surveillance of patients to undergo blood transfusions and will better document any concerns or reactions. The hospital also instituted ongoing training for nurses and other professionals who interact with these patients.

Other hospitals can learn from this incident. If world-renowned MD Anderson could make this type of mistake, what could be happening at smaller facilities? All health care entities, regardless of prestige or reputation, need to ensure that compliance protocols are followed every single time. Protocol helps protect against mistakes, negligence, and fraud. It must be ingrained in the culture. There need to be checks and balances to ensure that if one part of the chain is breaks, a safeguard kicks in to stop and address the negative action. Health care professionals have to be willing to hold each other accountable for protocol compliance. 

Not doing so can be deadly. 

Elissa Bird

By

Elissa Bird is an accomplished healthcare attorney with vast experience in providing legal counsel, risk analysis, and guidance to internal hospital departments and executive management.

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