The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

JOHNS HOPKINS HOSPITAL, THE 600 NORTH WOLFE STREET BALTIMORE, MD 21287 Nov. 14, 2013
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on review of 20 medical records, policies and procedures, and staff interviews, the hospital failed to ensure that 2 medical records were complete and accurate as required by the Federal regulation and as evidenced by:

In 2 of 20 medical record reviewed, it was determined that for patient #1 and patient #2 parts of the medical record are inaccurate and incomplete. The transfusion records for both patient #1 and patient #2 were incomplete. There was no date and time of initiation of blood transfusion or a time when the transfusion was complete. The "Anesthesia Data Record Hand-off Report 9/19/2013, 11:40 AM " for Patient #1 shows that 0 units of red blood cells were reported for " fluids in ", and no blood products were reported on the progress chart. In addition the transfusion records for Patient #2 were reviewed and the documentation for the start of transfusion, stop of transfusion and volume was missing for units W 77, W 07, W 74, W 31, W 29, W 46 and 22gv ; the documentation for the stop of transfusion and volume was missing for unit 22LP9185S and 01gL . Two additional units were properly documented.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on the interviews with staff, policies and procedures and other pertinent documentation, it was determined that the hospital failed to execute safety practices related to administration of blood and blood products in the operating room nor did they follow policy and procedure for patient identification and verification process before administration of blood product.

As indicated in A0951, on September 18, 2013 patient #1 was transfused with a unit of blood intended for another patient in an adjacent operating room. The blood was retrieved by an operating room technician from a Hemosafe. The transfused unit was incompatible with patient #1's blood type.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interviews, policies and procedures, and other pertinent documentation, the hospital failed to safely administer blood to patient #1 in the operating room. The investigation determined that :
1) the operating room technician retrieved the wrong blood from the Hemosafe;
2) no indication that a hand-off process occurred between the OR technician and OR anesthesia resident;
3) the required validation process and patient identification once the blood was taken into the OR was not performed;
4) the Hemosafe protocol and blood administration policy and procedure failed to outline specific steps needed to ensure appropriate acquisition of blood and identification of the patient before blood products are administered, and
5) the job description of the anesthesia critical care technician (CCT) does not address the staff's role in the blood transfusion process.

Patient #1 was a critically ill [AGE] year old male with multiple co-morbidities and significant medical history for coronary artery disease. The patient was transferred from another area hospital in poor condition after a ileo-femoral bypass. The patient had extensive cardiac disease, peripheral vascular disease and had been treated for deep vein thrombosis and gangrene. The patient was taken to the operating room for possible blood clot and ileo-femoral leak at the site of the surgery performed at the other hospital.

An Anesthesia Critical Care Technician was responsible for two adjacent operating rooms where patient #1 and patient #2 were having surgery. The Anesthesia Critical Care Technician assist the anesthesiologist in performing most of the technical anesthesia preparations for anesthesia. The CCT supports the operation of anesthesia by preparing, maintaining, cleaning, and when possible repairing equipment used during the anesthesia course. The CCT assists the physician or CRNA in the care and management of the anesthetized patient, which may include obtaining blood and blood products for transfusion.

During the surgery , the arterial hemoglobin for Patient #1 was recorded as as 7.2 g/dl at 12:38. As a result , the Operating Room Technician received a pager request to retrieve a unit of red blood cells for patient #1 from the HemoSafe (a storage cabinet for units of blood in the OR suite). The Operating Room Technician was in possession of identification tags for both Patient #1 and patient #2. The Operating Room Technician went to the HemoSafe to obtain the order for Patient #1. She mistakenly used the identification tag for Patient #2 when filling the order, which dispensed a unit of red blood cells (W 89S) for patient #2 at 13:04. The tech delivered that blood to patient #1 in the adjacent operating room.

The Operating Room Technician and the Anesthesiologist signed the "Anesthesia Data Record " to document that the patient identity (patient #1) was checked against the information on the unit of blood (labeled for patient #2). The check was not done in an accurate and reliable manner as patient #1 was transfused with an incompatible unit of blood. The blood transfusion forms did not indicate the time the blood transfusion began.

Due to "oozing at the (operative) site," 10mg. Protamine, a coagulant medication, was ordered and administered at 13:09. Subsequently, another 5 mg. was given. Thirty seconds after the Protamine was given the patient's heart rate, blood pressure and oxygen saturation dropped and chest compressions were started at 13:10. The incorrect red blood cell unit was clearing documented as being transfused during resuscitation.


It was noted in the Anesthesia Data Record hand-off report that the unit of incompatible red blood cells was infusing for at least 5 minutes before Protamine was given. However, the records from the operating room are not consistent with that report. Review of the operating room records revealed that blood usage appears as a note and an amendment stating that the unit of red blood cells was started at 13:13 and the unit was hanging on the IV pole when the protamine was given. The Anesthesia Data Report also stated "of note, a unit of packed red blood cells have been hung, and then administered subsequent to the arrest. A comment in the "unit inquiry" report for W 89 states that the transfusion was started at 13:10 and stopped at 13:20. The different forms and records are not consistent with each other in that there are varying times for the start of the transfusion. The actual time the blood was started is unknown since the blood transfusion slips lack a start time, making it difficult to determine the cause of the patient's code.

At 13:22, anesthesia determined that the unit of red blood cells transfused to Patient #1 was labeled and electronically cross-matched for patient #2 in the adjacent operating room. At the same time, transfusion medicine was notified of the error. A second unit of ABO compatible red blood cells was electronically cross-matched for patient #1 and correctly transfused to Patient #1 at 13:35.

At 13:32 the laboratory checked on the other operating room patients to assure that no other identification errors occurred or were ongoing. At 13:42 the use of the HemoSafe was suspended. It was later returned to service after it was determined to be functioning correctly.

Operating room records stated that a unit of red blood cells had been "hung, and then was administered subsequent to the arrest ... [and the incompatibility was] discovered approx 5 minutes later ... " and that the " ...blood reached the patient subsequent to the arrest, so did not contribute to the initial arrest. " The date and time of death of patient #1 is recorded as 9/18/13 at 14:52. The death certificate lists the cause of death as a adverse drug reaction to the Protamine.

At the time of the incident, the hospital policy and procedure was "Blood and Blood Component Transfusion, policy number PAT029," which was approved 6/25/13 and became effective 7/25/13. The policy and procedure is consistent with attachment Appendix B: "Blood and Blood Component Transfusion in the Operating Rooms."

The surveyors determined that the following events contributed to the transfusion of patient #1 with an ABO incompatible unit of red blood cells:

1. Review of the written procedure did not include instructions for obtaining and verifying the paper request used to retrieve a unit blood from the HemoSafe, when the originating request is made via pager or cell phone. The procedure "Interdisciplinary Clinical Practice Manual, Patient Care, Blood and Blood Component Transfusion, PAT029: Blood and Blood Component Transfusion, Appendix B, paragraph III, D, 3 " stated that: "The courier designated to transport the blood product to the OR shall stamp the patient's name and medical record number on the paper provided and ,prior to going to the Blood Bank, shall verify that it is the same patient name and medical record number documented on the "Anesthesia Data Record." A staff member of the pathology department stated that the operating room technician was notified of the blood request by pager. The Operating Room Technician was also reported to be holding two identification labels, one for each patient for whom she was responsible. The identification labels are used to get a unit of blood from the HemoSafe, and not the verified paper. In addition, the policy did not address the hand-off process between the carrier and the OR staff to include at minimum verification of the patient's name, date of birth and medical record number.

2. The training checklist used for training the operating room technician to dispense blood from the HemoSafe did not include instruction for obtaining a verified paper request and did not include detailed instruction on processing pager and phone requests for blood.

3. The Operating Room Circulating Nurse and the Anesthesiology Resident failed to properly check the match between patient #1 and the unit of incompatible red blood cells.

4. The transfusion records for both patient #1 and patient #2 were incomplete. (See the deficiency cited at A 450)

5. The written procedure " Interdisciplinary Clinical Practice Manual, Patient Care, Blood and Blood Component Transfusion, PAT029: Appendix B " states that "Any designated member of the OR team may serve as a courier to transport blood products to and from the Blood Bank or Blood Storage Refrigerator." However, the "CCT Guidelines for picking up and returning Blood Products " only refer to the position of "CCT" (critical care technician). The Operating Room Technician's job description and these other documents do not specifically state the role of the Operating Room Technician in the blood transfer process nor does it identify if an Operating Room Technician meets the definition of a "CCT."

6. The "Anesthesia Data Record Hand-off Report 9/19/2013 11:40 AM" for Patient #1 shows that 0 units of red blood cells were reported for "fluids in" and no blood products were reported on the progress chart. In addition, the transfusion records for Patient #2 were reviewed and the documentation for the start of transfusion, stop of transfusion and volume was missing for units W 77, W 07, W 74, W 31, W 29, W 46 and 22gv ; the documentation for the stop of transfusion and volume was missing for unit 22LP9185S and 01gL . Two additional units were properly documented.

It was noted by the surveyors that the hospital has revised the applicable policies and procedures and job descriptions, and implemented changes since this error occurred in September 18, 2013 and prior to the the survey. Nonetheless, the failure of staff to follow the policies and procedure for blood and blood product transfusion contributed to patient #1 receiving an ABO incompatible unit of red blood cells.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of the medical record of patient #1 and of quality data, it was detemined that the hospital had been tracking and trending information regarding blood and blood product transfusion from August 2013 Anesthesia and Critical Care Quality Minutes, however, the hospital's tracking failed to focus on the blood hand off process.

The hospital had been monitoring blood tarnsfusion use and waste and had identified problems during tracking with obtaining two signatures on the blood transfusion slips as part its quality tracking and trending. The hospital discussed adding a prompt to ensure the two required slips are dated, timed and signed. This investigation revealed that there were problems with the hand-off process for the carriers that pick-up the blood and with the identification and verification processes that occur in the operating room prior to transfusion as noted at A 951.