STATEMENT OF
ELWOOD HEADLEY, M.D.
MEDICAL CENTER DIRECTOR FOR THE
BOSTON VETERANS AFFAIRS MEDICAL CENTER
ON PATIENT INCIDENTS
BEFORE THE
SUBCOMMITTEE ON HEALTH
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES

October 8, 1997

Mr. Chairman, members of the subcommittee, thank you for the opportunity to present details regarding this incident. As requested this testimony will discuss in detail the circumstances of the case, the nature and findings of the investigations which occurred and the remedial steps taken.

CIRCUMSTANCES OF THE CASE:

The patient was a 60 year old man with a history of esophageal cancer, who underwent an esophagogastrectomy (an operation to remove the cancerous esophagus and attach the lower esophagus to the stomach) February 13, 1996. This was complicated by a leak of the anastomosis (site of reattachment) and renal and respiratory failure. On March 5, 1996 he was taken to surgery to have a re-exploration of the right chest and drainage, repair of the anastamosis and a tracheostomy to improve ventilation. He was severely ill and the highest risk category patient. The procedure was only undertaken because of the life threatening nature of his problem. During the procedure he suffered a cardiac arrest and attempts at resuscitation were unsuccessful and the patient expired. In the process of reviewing the circumstances surrounding Mr. Anderson's death it was discovered that he had received two units of packed red blood cells typed and cross matched for another patient. The Medical Examiner was notified and declined the case, however the family consented for the autopsy to be performed by the Medical Center. Acute hemolytic reaction secondary to incompatible ABO transfusion was identified as the immediate cause of death.

NATURE AND FINDINGS OF INVESTIGATIONS:

Fact finding was instituted immediately and an Administrative Board of Investigation was requested immediately and convened on March 8, 1996. It was chaired by the Director of Quality Management and consisted of the Associate Chief for Clinical Pathology and the Operating Room Nurse Coordinator.

The Board was charged with the following responsibilities:

• to investigate the transfusion error of March 5, 1996;
  

• to review the circumstances surrounding, and factors contributing to the error; and,
  

• to make recommendations to minimize recurrence.
  

In order to comprehensively review the incident the board tracked and evaluated what were felt to be essential aspects of care for this patient with regard to the blood transfusion including the:

• identification of the patient prior to and during the surgical procedure;
  

• effectiveness by which information was communicated between the interdisciplinary team;
  

• storage and handling of blood and blood products in the operating room;
  

• adherence to policy and procedure associated with the verification and administration of blood and blood products;
  

• timeliness by which the error was identified, reported and appropriate follow up initiated.
  

The following individuals were called as witnesses:

• The Attending Thoracic surgeon

• The Attending Anesthesiologist

• Three Operating Room Nurses involved with the case

• Blood Bank Supervisor

• Chief Anesthesia Section

• CRNA involved with the case

• One SICU Nurse
  

In addition, policies and procedures related to Transfusions of Blood and Blood Products, Standard Texts relating to Blood use, the Patient Incident Review Program and the Integrated Risk Management Program were reviewed. In addition, the patient's medical record was reviewed and the operating room refrigerator for the storage of blood and blood products was inspected.

FINDINGS:

Identification of the patient prior to and during the surgical procedure:

Each discipline (surgeon, anesthesia and nursing) identified comprehensive procedures for the identification of the patient prior to the procedure. Of note, however, this is not an integrated process. Each utilizes procedures that are specific to their discipline and conducts identification procedures as an intra-disciplinary, versus an inter-disciplinary process.

Effectiveness by which information was communicated among the interdisciplinary surgical team:

Each discipline as appropriate, described comprehensive procedures for the communication of essential patient information that was shared among the members of the team at various points during the procedure, such as at the time of transfer of responsibility for breaks. According to testimony, the extent to which information specific to patient identification is integrated into this process may vary. Of note, in this case a nurse assigned to assist in the room did not participate in patient identification procedures; however, he subsequently participated in the verification of blood prior to administration. Consequently, the omission of checking the patient's ID (wrist) band, by those participating in the verification became critical. Members of anesthesia who participated in the verification of the blood also participated in the care of the patient who preceded this patient in OR #7 and had, by then, begun to confuse the two patients. This was further precipitated by the storage of the previous patient's blood in the refrigerator marked for OR#7 following completion of the case and his transfer to the recovery room.

Because patient identification procedures are conducted by individuals rather than by the "team" without any subsequent interdisciplinary verification, this aspect of communication was felt to be less than optimal.

Storage and handling of blood and blood products in the operating room:

Blood and blood products are stored in the operating room refrigerator by room number, based on the operating room schedule and case assignment for a given day. Of note, as stated above, another patient's blood was located in the section of the refrigerator compartment marked as OR#7. Both the patient and the previous patients procedures were performed in OR#7 with blood ordered for both cases. The patient's blood was later found to be stored and marked for OR#6. The exact process by which the blood was inaccurately stored in this instance could not be ascertained in spite of comprehensive review.

The board feels that the storage of blood products and the identification of blood in the OR by room number rather than by patient increases the risk of errors. This aspect of care is not currently addressed in any existing policy or procedure.

Adherence to policy and procedure associated with the verification and administration of blood and blood products:

Policy and procedure clearly state that the verification process requires the confirmation of patient identification as reflected on the ID (wrist) band. This step was omitted during the verification process used for both units of blood.

Timeliness by which the error was identified, reported and appropriate follow-up initiated:

The timeliness by which appropriate follow-up, according to established protocol, was initiated was less than optimal. This included notification of the blood bank, notification of the Chief of Staff or Risk Management and the initiation of the protocol for suspected blood transfusion reaction.

Based on testimony, notification and follow-up was delayed because of a lack of knowledge on the part of the medical staff. Both consultants (surgeon and anesthesia) reported the incident to their Section and Service Chiefs in a timely manner, however, there was a significant delay in the information reaching either the Blood Bank or Quality Management Office in accordance with established policy.

CONCLUSIONS:

The transfusion error was directly attributable to human error. If the verification process included the confirmation of patient identification as reflected on the ID (wrist) band, the incident could have been avoided.

While the transfusion error was clearly the result of human error there are opportunities to improve existing policy and procedure and minimize the risk of recurrence.

The Surgical Service was less than timely in reporting this incident in accordance with established policy.

REMEDIAL STEPS TAKEN:

In addition to the Administrative Board of Investigation summarized above, a Root Cause Analysis was performed which is a method of reviewing processes as an aid to
restructuring them. No new information was introduced as a result of the Root Cause Analysis, it merely assisted in planning the remedial actions. Based on the results of the Administrative Board and the Root Cause Analysis it was decided to re-engineer our blood and blood products policies and procedures and the following steps were implemented.

Letters of reprimand were issued to the Anesthesiologist, the Certified Nurse Anesthetist and the Nurse involved.

There was a redesign of the process to assure interdisciplinary verification of patient identification prior to the initiation of anesthesia or procedure and prior to the administration of Blood or Blood Products.

There was a redesign of the process to a uniform system of dispensing blood to the operating room by individual patient rather than in bulk and eliminating storage of blood outside of the Blood Bank, minimizing risks to patients.

There was a change in policy to require documented informed consent for blood transfusion medical center-wide to facilitate active involvement of patients in treatment decision-making processes.

Educational programs addressing all of the above were instituted hospital-wide with special emphasis on the operating room.

Educational programs on Risk Management were presented hospital-wide with emphasis on the operating room.

An annual review of blood and blood product administration was instituted in the hospital's ongoing clinical staff education program.