JOHNS HOPKINS MEDICINE STATEMENT IN RESPONSE TO SURVEYS BY OFFICE OF HEALTH CARE QUALITY, MARYLAND DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Background: Johns Hopkins Medicine last December promptly reported to state agencies, and took responsibility for the untimely death of Brianna Rose Cohen, two-and-a-half years old, of Owings Mills, Maryland. The child was, at the time of her death (at another Baltimore hospital), a pediatric cancer outpatient at The Johns Hopkins Children's Center receiving Total Parenteral Nutrition (TPN) through intravenous infusion services provided by Pediatrics at Home, a subsidiary of the Johns Hopkins Home Care Group, which is jointly owned by The Johns Hopkins Health System and The Johns Hopkins University.

At that time, Hopkins also cooperated fully with the family, the Maryland Department of Health and Mental Hygiene (DHMH) and other agencies in their quests for information and in all investigations. In addition, Hopkins quickly put in place substantive measures to further assure patient safety – our number one goal – and pledged to take additional steps to address any specific problems revealed by the state and internal investigations.

Response to DHMH Reports: As described in two DHMH reports dated February 18, (one for the Home Care Group services and one for The Johns Hopkins Hospital pediatric oncology clinic) some major and some relatively minor deficiencies related to processes, policies and supervision require corrective action by Hopkins. Many of these emerged from Hopkins's own analyses of Home Care Group services, and already have been addressed. Completed formal action plans will be submitted in detail to the state in accordance with DHMH rules.

While Hopkins takes these deficiencies very seriously and is committed to rapidly implementing corrective actions, the public and our patients should know that all Home Care Group and Hospital facilities and services mentioned in the DHMH survey remain fully licensed.

Similarly, the Home Care Group was fully re-accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) in May, 2003 and patient satisfaction surveys have given high marks to services.

Johns Hopkins Home Care Group currently has more than 5000 patients on its rolls, including 800 patients actively receiving infusion services.

The DHMH reports address issues that fall into broad categories. JHM's corrective action plans will address them all. Some basic elements of those plans and response to some comments in the surveys appear below:

• Notification: Johns Hopkins Medicine officials promptly reported events related to Brianna Cohen's death both to DHMH and JCAHO on December 17, 2003, and launched a thorough internal examination of the event. While a newspaper article may have led to a DHMH complaint investigation, DHMH had notification of the incident well before the newspaper article.

• Quality assurance program: A vice president for oversight of infusion has been appointed, with a mandate to focus on improving safety processes and earlier identification of issues that may put patients at risk.

• Staff issues: The Home Care Group's pharmacy and Pediatrics at Home services are entirely staffed. More frequent evaluations will be made of all staff and recruitment is underway for another top level pharmacist to enhance oversight of safety and quality in pharmacy operations.

• Medication monitoring and production processes and policies: Home care patients have complex, chronic medical problems and multiple medication needs. Senior staff at the Home Care Group have been assigned to conduct continuous, coordinated review of medical procedures and safety policies. Literally tens of thousands of prescriptions are safely written, filled and used by home care patients each year. While the goal at Hopkins is prevention of all medication problems, numerous national studies suggest that every health care organization must expect some, and must commit to ongoing, long-term programs of safety. Hopkins has done so.

• Documentation of operations, training and policy implementation: Efforts are underway to further upgrade and update policies and training related to coordination among, and skills for, all care givers.

• Clinical record keeping: Because home care patients are served by a variety of care givers and facilities, integrating patient records is a complex undertaking. Hopkins is exploring further ways to assure that all care givers have a more complete picture of a patient's clinical record and has redesigned daily pharmacy rounds to enhance patient safety and coordination of care.

• Administrative oversight and functions: Preliminary formal policy reviews and updates of administrative responsibilities have been completed.

• Communications and consultation: Policies and training will be upgraded and enhanced to better ensure formalization of verbal orders.

• Pediatric Oncology Clinic: Requests for additional resources have been made to enhance administrative functions related to coordination of outpatient services. An "order" policy which requires clear and mandatory "start" and "stop" dates will be created. The pharmacist in the Oncology Clinic can now enter TPN orders for Home Care patients from any computer terminal at The Johns Hopkins Hospital.