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ATTACHMENT A — UNIVERSITY OF VIRGINIA MEDICAL CENTER REPORT

Special Committee to Review the Processes and Operations of the University of Virginia
Medical Center
Report to the Board of Visitors and General Counsel
January 29, 1999

I. INTRODUCTION

The Special Committee to Review the Processes and Operations of the University of Virginia Medical Center, appointed by the Rector at the Board of Visitors' meeting on October 10, 1998, has completed its review. The committee was asked to investigate and review hospital procedures as they relate to the "baby switching" incident of 1995 and the two "morgue" incidents which occurred in 1996 and 1998 (see the attached statement by the Rector from the minutes of the Board.)

The committee undertook to fulfill its charge by:

• 1. learning what had occurred;
• 2. understanding the probability of each occurrence;
• 3. understanding hospital procedures in each area related to the occurrences;
• 4. learning what in-house changes were made as a result of each occurrence; and 5. generating recommendations for changes in each area of concern.

After a thorough initial briefing and review of written reports, the committee decided to review management accountability at all levels. The committee was especially interested in the timeliness of the communication and documentation of any procedural shortfalls, as well as corrective action taken to ensure that adverse incidents would not reoccur. The committee did not conduct extensive surveys of, for example, individual patient records or daily operations over a period of time, because the Virginia Department of Health and the Joint Commission for the Accreditation of Healthcare Organizations were already doing so. Nor was its purpose to replicate investigations conducted by the University Police and the Virginia State Police.

The committee was initially briefed on each incident by the Director of Risk Management, Abraham Segres, and the Director of Quality Programs, Christine Matt. Members of the committee and the Director of Audits toured the Medical Center's Labor and Delivery Department and Morgue to view their operations, and the Chair made tours of departments at hospitals elsewhere in Virginia. At its first meeting the committee received four reports that had been generated by various Medical Center departments in response to the Labor and Delivery and Morgue incidents:

• 1. An Internal "Root Cause" analysis of the baby switch, prepared by a Quality Review team led by Ms. Matt, as specified by Medical Center policy and JCAHO rules;
• 2. The initial Risk Management summary of the Morgue incidents;
• 3. An internal Process Improvement report on the Morgue incidents, prepared by
• the Medical Center's Director of Operations Improvement;
• 4. the Ad Hoc Infant Safety and Security Task Force Report.

These reports gave an overview of what happened, what could have happened, and what might have happened if existing procedures were followed. The first two reports showed the Committee members the accountability trail that existed at the time of each incident's occurrence. These two reports made an attempt to reconstruct the events in order to make some sense out of how a "switch" could in fact have happened.

The third report, "Internal Process Improvement," advised the committee of procedural changes the staff had either implemented or was in the process of implementing to further safeguard patient care. These changes are listed in Section II of this report.

The fourth report, from the Ad Hoc Infant Safety and Security Task Force, presented the Committee with information concerning the identification process for newborn infants, as well as a complete overview of security systems not only on the Labor and Delivery floor, but also throughout the hospital. The Task Force was charged "with designing a comprehensive infant protection system," which would put the Medical Center on the cutting edge of hospital security. The improvements the Task Force has initiated to date are listed in Section II below.

After reviewing the in-house reports, the committee felt confident that Medical Center administrators were committed to understanding how the incidents occurred and were unified in their search for more stringent procedures to prevent any recurrence.

There were two external reports not completed within our committee's investigative time frame. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) report has still not been received by the University. The Virginia Department of Health's final report, dated January 11, 1999 and received by the University January 18, 1999, was generated after a six (6) week on-site survey of the Medical Center that ended on September 20, 1998. (The report was distributed to the committee on Monday, January 25, 1999.) The Department of Health was charged by the federal Healthcare Financing Administration (HCFA) with investigating the Labor and Delivery and Morgue incidents in relation to the Medical Center's ability to comply with Medicare "conditions of participation." Its report found the Medical Center to be out of compliance with Medicare requirements, because of a lack of documented procedures and certain inconsistencies in patient care in Labor and Delivery and the Morgue. Medical Center management is now preparing its plan of correction in response to the Department of Health report. Copies of the response will be provided to the committee and the Board. Because the Department of Health completed its survey at the Medical Center in mid-September, 1998, it was unaware of, and could not take into consideration, the positive changes since implemented by Medical Center administration. Many of these changes directly address the noncompliance issues raised in the report. Nonetheless, the committee is concerned about the allegations in the Department of Health's report, and requests that the Rector allow the committee to remain intact until such time as the committee members are satisfied that the University has complied with all Medicare regulations.

II. HOSPITAL-IMPLEMENTED CHANGES

As a result of the reported incidents in Labor and Delivery and the Morgue, the Medical Center's management has already made many positive changes in operating procedures:

A. Labor and Delivery

• 1) Umbilical cord clamps are now used in addition to the traditional identification bracelets. Identification bracelets, which have a clamp that can be tightened but not loosened, are now placed on both ankles of an infant instead of on one ankle and one wrist. The likelihood of an umbilical cord clamp becoming accidentally dislodged is remote; in the three months since the clamp has been put in use, none has done so.
• 2) Only staff with a purple badge are permitted to transport babies on the Labor and Delivery floor. Fathers and other visitors to the mother and baby are no longer permitted to do so.
• 3) Placentas that do not require examination are now stored on the Labor and Delivery floor and are disposed of after seven days.
• 4) On the Labor and Delivery floor, entry and exit have been restricted and monitored through the use of alarms and cameras.
• 5) Signs have been placed at the entrances in front of elevators informing visitors that they must obtain a visitor badge from the information desk prior to visiting inpatients.
• 6) Access to Labor and Delivery scrubs has been restricted, via locks on locker room doors.
• 7) Mother and infant ID bands are being stored in a more secure location and access to them is more restricted.
• 8) The Labor and Delivery Unit Assistant Desk area has been remodeled to increase visibility of people entering the unit.
• 9) A stringent re-banding policy has been initiated, to cover cases where bands fall off or are removed.
• 10) A policy has been initiated to assure that mothers and infants arriving through the Emergency Department are banded with matching numbered bands and umbilical clamp before they leave that area. 11) Nurses now document when ID bands and clamp are placed on the mother and infant in the delivery room, and on what extremities.
• 12) The discharge policy has been revised to clearly state that a staff member will assist the mother and infant from the Labor and Delivery floor to the lobby.
• 13) A column has been added to the nursing flow sheet to document the ID checks that are now required every time a mother and infant are separated and reunited.
• 14) A "Patient Responsibility" sheet has been created to teach mothers how they can help maintain a safe environment for their infants while in the hospital.

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  15) The computerized Discharge/Furlough order form has been changed: prompt requesting documentation of the mother's ID number, the infant's ID number and locations of bands are now automatic.
• 16) Daily chart audits are being conducted to evaluate compliance with the new policies and documentation expectations.

B. Pathology and Morgue

• 1) Separate holding areas have been created for fetal remains being discharged to funeral homes or families, and those remains designated for disposal by the Medical Center.
• 2) Autopsy personnel no longer have keys to the Morgue and must be admitted by staff administrators. There is also a sign-in and sign-out procedure for Morgue keys needed by transporters delivering remains to the Morgue.
• 3) A camera has been installed in the Morgue to monitor the proper performance of procedures in that area.
• 4) As an interim measure, staff administrators now are present at and responsible for all releases of remains from the Morgue. Removal of the drawer card in the Morgue is the responsibility of the staff administrator at the time of release.
• 5) The pick-up log in Labor and Delivery has been redesigned to separate the documentation of the release of a fetus to the Morgue from the request for transport of a placenta specimen to pathology.
• 6) Only when a placenta cannot be separated from the fetus will it be sent to the Morgue. These remains will be placed in a single body bag, not a plastic specimen container.
• 7) Remains must now be transported from the unit where death occurred to the Morgue within two hours of death, unless the grieving family requests a longer time to remain with the body.
• 8) The staff administrator now releases fetal remains designated for cremation by the Medical Center from the Morgue weekly, or as needed, to the designated pathology/autopsy staff member who is currently responsible for cremation.

C. Senior Administration Accountability

The Director of Risk Management and the Director of Quality Programs now meet every other week with the Vice President and Provost for Health Sciences. The purpose is to bring problems in the provision of patient care to his attention, and to plan corrective actions.

The committee commends the Medical Center administration for thorough review of its own procedures and endorses the changes initiated. We believe these changes should improve operations and significantly decrease the likelihood of adverse events. However, we recognize that changes to procedures are effective only if consistently carried out. We strongly urge the Medical Center administration to hold staff accountable for their responsibilities.

COMMITTEE RECOMENDATIONS

The committee makes the following recommendations for further improvements in edical Center Operations.

A. Departmental Improvements

• 1) Labor and Delivery Unit Procedures: There is an extra adult identification wrist band in the packages with the new umbilical clamp, besides the wristband intended for use by the mother. Since the Medical Center has stopped allowing fathers and other visitors to transport babies within Labor and Delivery, this second adult wristband is not needed. The procedures in place when the committee did its investigation called for the attending nurse to dispose of this extra wristband, but there was no procedure for documenting the disposal. If the wristband is not properly disposed of, it could be used by an unauthorized individual to procure a baby from the nursery or to have access to a baby without the mother's knowledge. Recommendation: The Medical Center should purchase packages with only one adult wristband. The committee believes this would decrease the possibility of unauthorized persons having access to an infant. Until the new packages of wristbands are obtained, disposal of the second adult wristband must be documented in the patient's medical record.
• 2) Morgue Administration: When the committee reviewed the procedures for releasing remains ftom the Morgue, it discovered that no one person or department was charged with responsibility for release. Bodies were being given to funeral homes and families by transport workers, rather than by an individual specifically designated and trained for this task.
• Recommendation: The committee recommends that all releases of remains from the Morgue be performed by a designated person or persons. The ideal situation would be to centralize Autopsy and the Morgue in one room so that transfers from area to area would be minimized. Also, we would recommend that one person be responsible for this area and for ensuring that the inventory of bodies, organs, and products of conception is accurate and complete. This person would also be responsible for releasing remains under routine circumstances.

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  Additionally, an individual or individuals should be charged with ensuring that fetal remains that might be claimed by the family make it safely from Labor and Delivery to the Morgue. Designating specific persons to be responsible for these tasks should improve consistency in their performance. During each move between departments, accountability must be ensured by means of a "check-in" and "check-out" system within each department.
• We also recommend that when remains are released to a family (a rare occurrence), they be offered the help of a chaplain or bereavement counselor, which the family could accept or decline. With few exceptions, all releases of remains should be done during designated business hours, and a designated administrator should personally handle both after-hours releases and unusual cases, including release of remains to families. All persons handling fetal remains, including products of conception, should receive sensitivity training so that proper consideration is given to the handling of these remains and to the families involved.

B. Medical Center-Wide Improvements

• 1)Compliance Officer Position: The Compliance Officer position recently authorized for the Medical Center has yet to be filled. An initial advertisement and round of interviews produced no acceptable candidates; a second round is now planned. The Compliance Officer will be responsible for assisting healthcare professionals in complying with federal and state regulations applicable to medical centers, including the vast array of Medicare and Medicaid billing rules.
• Recommendation: The committee feels quite strongly that the Compliance Officer position should be re-advertised and filled promptly with a qualified candidate. This individual should be responsible for helping healthcare providers conduct their billing and other activities in accordance with regulatory requirements. This position will help to ensure that the Medical Center is accountable to outside agencies and programs such as Medicare and Medicaid, as well as to the taxpayers. The committee supports the proposal that the Compliance Officer report directly to the Executive Vice President and Chief Financial Officer.

• 2)BOV Oversight: As a final step in its review, the committee considered the relationship between the Medical Center and the body responsible for its oversight, the Board of Visitors. Currently this responsibility is exercised primarily through the Health

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  Affairs Committee of the Board. That committee's meetings are relatively brief and infrequent, considering the complexity of the institution it is monitoring. Moreover, its current structure does not give the committee easy access to independent, specialized expertise in healthcare matters, which it could use to do its job most effectively. At present there is only one member of the committee (and of the entire Board) with significant experience in the healthcare industry.
• Recommendation: The committee recommends that the Rector restructure the Health Affairs Committee to include, in an advisory capacity, professionals from relevant sectors of the business community, including the healthcare industry. The Health Affairs Committee should be comprised of five board members: three appointed at large, the Health Affairs Committee Chair, and the Finance Committee Chair. In addition, at least three outside experts should be appointed by the Rector and act in an advisory capacity as nonvoting members. Persons with experience and expertise in relevant business sectors, particularly in fields such as managed care and medical insurance, should be the types of individuals who would serve as advisors to the Health Affairs Committee.
• The committee also recommends that there be a direct link to the Healthcare Partners Board of Trustees from the Board of Visitors. Two voting Board members of the Health Affairs Committee should serve on the Healthcare Partners board to ensure a cross-fertilization of deliberations and plans. We further recommend that the three outside experts appointed by the Rector to advise the Health Affairs Committee should also be members of the Healthcare Partners Board. To round out that membership, the Health Services Foundation should have one representative. Our proposed structure would ensure that the Board of Visitors, which is the ultimate decision maker about, for example, acquisition of outlying businesses, is informed of proposed ventures in a more timely manner and can have a more immediate impact on Medical Center operations.
• It is our hope that the Health Affairs Committee, restructured as described above, would assist the Medical Center in a more direct way. This also would require the Health Affairs Committee to meet frequently enough to address issues on a timely basis. The meetings should be long enough to give the members a deeper understanding of Medical Center operations.

IV. CONCLUSION

The committee commends the Medical Center's speedy and thorough investigation of its processes, and the improvements it has made. Those improvements and the ones recommended here will be effective only if staff are thoroughly trained, given clear

directions and held accountable for their actions. The committee urges the Medical Center to assure that its training, communication and supervision are up to the job.