On November 10, 2014, the US Department of Health and Human Services released its investigation report regarding the death of actress and comedian Joan Rivers. The report, called a “Statement of Deficiencies and Plan of Correction”, highlights numerous mistakes and violations made by Yorkville Endoscopy, the treating facility where Ms. Rivers died (Ms. Rivers was identified as “Patient #1”). Health care providers, facility owners, and administrators can learn some basic but important lessons from the report’s findings.
1. Have appropriate policies and procedures (“P&Ps”) in place as required by your licensing agency and accrediting body. Yorkville Endoscopy is licensed by the State of New York as an ambulatory surgery center (“ASC”) under Article 28 of the Public Health Law, and accredited by the American Association for Accreditation of Ambulatory Surgery Facilities. The State regulatory requirements for an ASC are much more rigorous than the requirements for non-licensed outpatient surgery centers in New York. P&Ps cover issues including clinical practices, patient consents, procedures, anesthesia, billing, provider credentialing, employment and more. An administrator, compliance officer, or other responsible party may review the regulations and accreditation standards, consult with the accrediting body, legal counsel or a consultant, and can purchase policy manuals from numerous sources.
2. Follow your own policies and procedures. The report cites numerous examples of Yorkville Endoscopy failing to follow its own P&Ps. For example, the staff failed to follow the “Time Out” policy which helps ensure that the correct procedure is being performed; also, one of the physicians performing the procedures was not credentialed by the facility, in violation of the Physician Credentialing P&P. A facility’s P&P manual should not be gathering dust on a shelf in a back office (same goes for the Compliance Manual). If a particular policy or procedure is not effective, the facility should develop a new policy or procedure that works better. A facility that consistently follows its own P&Ps exhibits traits of a compliant and quality oriented organization; while this will not prevent accidents or unexpected occurrences, many issues may be avoided. All staff, including physicians, should be regularly educated on the facility’s P&Ps.
3. Credentialing protects you. The federal report stated that one of the physicians performing a procedure on Ms. Rivers was not credentialed by the facility. Credentialing is a fairly simple process that allows a facility to review a provider’s licensure, education and work history, insurance, and past lawsuits or disciplinary actions before allowing them to treat patients. This enables a facility to determine whether a provider meets facility requirements in general, and often whether they are qualified for specific procedures. This helps weed out bad providers up front, limits certain procedures to physicians with an appropriate level of training and experience, and allows the facility to have a record of who is providing services under its roof.
4. Keep the cameras away from the patients. The report notes that one of the physicians took a photograph of Ms. Rivers with his cell phone while she was under sedation during a procedure. There is no evidence she consented to this photo. This is a violation of Ms. Rivers’ right to privacy (under HIPAA and State laws), and violated the facility’s own “Cell Phone Policy.” Taking photos of patients without their consent exposes the individuals and their facilities to liability, and often results in loss of employment for the offending staff. Facilities should review their photo and video policies, with an eye toward protection of the privacy of patients, staff and guests.
5. Beware of “VIP Medicine”. Accommodating a VIP in certain ways is reasonable and acceptable, but it is not occasion to ignore important policies and procedures. The investigation states that Ms. Rivers’ medical record did not contain an informed consent for the nasolaryngoscopy, and contained no documentation of her body weight (needed to calculate anesthesia dosages). Allowing a VIP to enter though a separate door to increase their privacy, keeping their visit private, or using a private room are certainly appropriate. However, clinical guidelines should be followed regardless of the star power of the patient. This means they must be subject to the same clinical oversight, undergo the same process for obtaining informed consent for any procedure, and receive the same pre-procedure screening and testing in accordance with good medical practices.
It is unknown whether compliance with any of the above-noted issues would have resulted in a better outcome for Ms. Rivers – sometimes the negative risks discussed during the informed consent process do occur, and sometimes this results in the death of a patient. What is clear is that inattention to regulations, failing to follow basic policies and procedures, and violating a patient’s rights suggest a facility and providers that fail to place a high value on quality of care and the safety of their patients.