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Based on record review and staff interview, it has been determined that the hospital failed to meet the Patient's Rights Condition of Participation for Patient ID #1 relative to the Blood Bank's administration of blood products resulting in Immediate Jeopardy. Additionally, the hospital failed to maintain professionally approved standards for safety relative to reporting critical X-ray results to the treating physician for Patient ID #2.

Findings are as follows:

1. The hospital failed to provide Laboratory Services in accordance with the their policy for "Release for Emergency Blood Transfusion" for Patient ID #1 which resulted in the patient recieving O+ blood instead of O- blood. (refer to A-0144)

2. The hospital failed to provide Radiology Services in accordance with their policy for "Critical/Alert Results of Tests and Diagnostic Procedures" for Patient ID #2 which resulted in a delay in reporting critical radiology results. (refer to A-0144)

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Based on record review, policy review and staff interview, it has been determined that the hospital failed to follow its own policy relative to the laboratory distribution of blood products and dispensing an emergency blood transfusion for 1 of 1 sample patients, Patient ID #1, resulting in a Immediate Jeopardy, and reporting of critial radiology results to the provider for 1 of 1 sample patients, Patient ID#2.

Findings are as follows:

1. In July 2021, Patient ID #1 presented to the hospital's Emergency Department (ED) after being found unresponsive at a nursing facility. While in the ED, the results of his/her bloodwork revealed a critically low hemoglobin (the oxygen carrying part of blood) which required emergent administration of several blood transfusions prior to determining the patient's blood type. During the second transfusion, the donor blood was released from the laboratory Blood Bank without proper verification of blood type and Rh Type (positive or negative blood type), as per policy, which resulted in Patient ID #1 incorrectly being administered O positive blood instead of the intended O negative blood type.

The hospital's "Release for Emergency Blood Transfusion" Blood Bank policy, effective date 6/1/2019, states in part,

"Table for Product Selections in Emergency Situations: [If the] patient ABO/Rh [ blood type is] unknown [then] Group O Rh Neg [blood is to be] selected ..."

During surveyor interview with the Director of Laboratory Services on 7/22/2021 at 12:38 PM, she acknowledged that O negative blood should be administered to patients with unknown blood type requiring an emergency transfusion.

She further stated that, in speaking with Staff D, the staff member who released the blood from the Blood Bank, he stated that there were 2 units of blood in the Blood Bank refrigerator awaiting release, and, in haste, when the ED called for the second unit of blood for Patient ID #1, he inadvertently removed the O positive blood that was prepared for another patient, "removed the Blood Bank transfusion tag", and signed the blood out to Patient ID #1 without verifying the blood was Group O Rh Negative. Furthermore, he adhered the orange colored uncross matched blood sticker to the donor blood bag. This error resulted in Patient ID #1, who was an unknown blood type, incorrectly receiving approximately 50-125 cc's (cubic centimeters) of O positive blood instead of the intended O negative blood.

During an interview with the physician who verbally ordered the transfusion, Staff E, on 7/23/2021 at 9:00 AM, he stated, based on the patient's unknown blood type, the patient was to receive O negative blood.


2. Record review for Patient ID #2 who presented to the hospital's Emergency Department (ED) via ambulance in July 2021 with complaints of hyperglycemia (high blood sugar levels). S/he was noted to have poor intravenous (IV) access, and, after several unsuccessful IV attempts the physician informed Patient ID #2 that s/he required placement of a right internal jugular (IJ) central venous line (CVL, an IV in a neck vein). The CVL was placed at approximately 12:30 AM and the physician read a preliminary X-ray (Chest X-ray) report at 1:12 AM as correct line placement.

Review of hospital policy titled, "Critical/Alert Results of Tests and Diagnostic Procedures", last reviewed 9/2017, states in part:

"...Definitions:

Critical Test Result: Any finding that may be considered life threatening or that could result in severe morbidity and require urgent or emergent clinical attention. Verbal communication of results to the ordering physician are required ...

e. Diagnostic Imaging ... The radiologist...will communicate a critical result (Attachment 2) directly to the ordering physician ...within one hour from the time the result is known..."
Review of above referenced, Attachment 2, lists "critically misplaced tube or catheter", under "Radiology Services - Critical results".

A second X-ray for Patient ID #2 was taken at approximately 5:00 AM, to check placement of a nasogastric tube (NGT, a catheter inserted through the nose, down the throat and esophagus, and into the stomach).

At 6:16 AM the radiologist interpreted the second Chest X-ray as the "CVL" being incorrectly placed, in Patient ID# 2's Carotid Artery, and not in the Jugular Vein, as intended.

Nursing notes reveal at approximately 6:40 AM Patient ID #2 was noticed to be lethargic (sleepy) and was not moving his/her left side. A brain cat scan (CT) was performed and revealed a "large MCA infarct" (middle cerebral artery (MCA) stroke describes the sudden onset of focal neurologic deficit resulting from brain infarction or ischemia. A neck CT was immediately performed and revealed that the central line had been placed in the right carotid artery.

At 8:05 AM the radiologist added an addendum to his initial reading completed at 6:16 AM, of the first Chest X-ray, indicating the "CVL" was incorrectly placed in Patient ID#2's Carotid Artery and this was reported to the ED Physician, Staff C at 7:35 AM.

On 7/23/2021 at 10:15 AM, surveyor interviewed the radiologist responsible for reading Patient ID #2's X-ray films. He revealed that when he reviewed the second X-ray that was completed at approximately 5:00 AM, which was ordered to check the placement of the NG tube, he identified the "CVL" was in Patient #2's Carotid Artery. He was unable to explain why he did not report the critical findings of the X-ray that he had identified at 6:16 AM, to the ED physician, Staff C, until 7:35 AM, which was not within one hour, as required by the hospital's policy.

Based on record review and staff interview, it has been determined that the hospital failed to meet the Condition of Participation for Nursing Services for patient ID #1 relative to the administration of blood products resulting in Immediate Jeopardy.

Findings are as follows:

1. The hospital failed to provide nursing care in accordance with the hospital policy for "Blood and Blood Components: Orders, Consent, and Administration" for Patient ID #1 resulting in the patient receiving the wrong blood type. (refer to A-0410)

Based on surveyor review of the patient's medical record, policy review and staff interview, it has been determined that the hospital failed to follow its own policy relative to nursing administration of blood for 1 of 1 sample patients, Patient ID #1.

Findings are as follows:

In July 2021, Patient ID #1 presented to the hospital's Emergency Department (ED) after being found unresponsive at a nursing facility. The results of his/her bloodwork revealed a critically low hemoglobin (the oxygen carrying part of blood) which required the administration of several blood transfusions prior to determining the patient's blood type. During the second transfusion, the donor blood unit Rh Type (positive or negative blood type) was not verified by nursing which resulted in Patient ID #1 being administered O+ blood instead of the intended O- blood type.

The hospital's "Blood and Blood Components: Orders, Consent, and Administration" policy, last reviewed on 7/1/2017, states in part,

"III. Procedure: ...
1. The transfusionist (the person who administers the transfusion) and a second person (co-identifier) will ensure the following: ...
i. The patient's name and Medical Record Number ...
iv. Donor or blood unit ABO group [blood type] / Rh Type ..."

On 7/22/2021 at 12:15 PM surveyor interviewed the Registered Nurse (RN), Staff A, who administered the blood to Patient ID #1. Staff A stated that this blood transfusion was administered in an "emergency situation," which requires the administration of uncross matched, O negative blood. Staff A further stated that she and the co-identifier relied on the "uncross matched, bright orange sticker" on the front of the bag instead of the donor blood label on the front of the blood bag and/or the slip attached to the blood bag to identify the donor ABO group/Rh Type. This omission in following policy resulted in O positive blood being administered to Patient ID #1 instead of O negative blood. Staff A further stated that it was not until she was notified by the Blood Bank that the incorrect blood was being transfused that the error was identified.

During surveyor interview with the Director of Laboratory Services on 7/22/2021 at 12:38 PM, she stated that O negative blood should be administered to patients with unknown blood type requiring an emergency transfusion.

Based on record review and staff interviews, it has been determined that the hospital failed to follow policies and protocols related to notifying the ordering physician of a critical result for 1 of 1 Patient ID #2.

Findings are as follows:

Record review for Patient ID #2 who presented to the hospital's Emergency Department (ED) via ambulance in July 2021 with complaints of hyperglycemia (high blood sugar levels). S/he was noted to have poor intravenous (IV) access, and, after several unsuccessful IV attempts the physician informed Patient ID #2 that s/he required placement of a right internal jugular (IJ) central venous line (CVL, an IV in a neck vein). The CVL was placed at approximately 12:30 AM and the physician read a preliminary X-ray (Chest X-ray) report at 1:12 AM as correct line placement.

Review of hospital policy titled, "Critical/Alert Results of Tests and Diagnostic Procedures", last reviewed 9/2017, states in part:

"...Definitions:

Critical Test Result: Any finding that may be considered life threatening or that could result in severe morbidity and require urgent or emergent clinical attention. Verbal communication of results to the ordering physician are required ...

e. Diagnostic Imaging ... The radiologist...will communicate a critical result (Attachment 2) directly to the ordering physician ...within one hour from the time the result is known..."
Review of above referenced, Attachment 2, lists "critically misplaced tube or catheter", under "Radiology Services - Critical results".

A second X-ray for Patient ID #2 was taken at approximately 5:00 AM, to check placement of a nasogastric tube (NGT, a catheter inserted through the nose, down the throat and esophagus, and into the stomach).

At 6:16 AM the radiologist interpreted the second Chest X-ray as the "CVL" being incorrectly placed, in Patient ID# 2's Carotid Artery, and not in the Jugular Vein, as intended.

Nursing notes reveal at approximately 6:40 AM Patient ID #2 was noticed to be lethargic (sleepy) and was not moving his/her left side. A brain cat scan (CT) was performed and revealed a "large MCA infarct" (middle cerebral artery (MCA) stroke describes the sudden onset of focal neurologic deficit resulting from brain infarction or ischemia. A neck CT was immediately performed and revealed that the central line had been placed in the right carotid artery.

At 8:05 AM the radiologist added an addendum to his initial reading completed at 6:16 AM, of the first Chest X-ray, indicating the "CVL" was incorrectly placed in Patient ID#2's Carotid Artery and this was reported to the ED Physician, Staff C at 7:35 AM.

On 7/23/2021 at 10:15 AM, surveyor interviewed the radiologist responsible for reading Patient ID #2's X-ray films. He revealed that when he reviewed the second X-ray that was completed at approximately 5:00 AM, which was ordered to check the placement of the NG tube, he identified the "CVL" was in Patient #2's Carotid Artery. He was unable to explain why he did not report the critical findings of the X-ray that he had identified at 6:16 AM, to the ED physician, Staff C, until 7:35 AM, which was not within one hour, as required by the hospital's policy.

Based on record review and staff interview, it has been determined that the hospital failed to meet the Condition of Participation for Laboratory Services for 1 of 1 Patient ID #1, relative to dispensing the incorrect blood type resulting in Immediate Jeopardy.

Findings are as follows:

The hospital failed to provide Laboratory Services in accordance with The FDA (Food and Drug Administration) Code of Federal Regulations, Title 21 Part 606 (Current good manufacturing practice for blood and blood components), Subpart G- Additional labeling standards for blood and blood components, contributing to Patient ID #1 receiving the wrong blood type. (refer to A-0593)

Based on record review and staff interview, it has been determined that the hospital failed to follow the FDA regulations relative to the Blood Bank blood labelling of donor blood for 1 of 1 sample patients, patient ID #1.

Findings are as follows:

Record review for Patient ID #1 reveals s/he presented to the hospital's Emergency Department (ED) after being found unresponsive at a nursing facility. The results of his/her bloodwork revealed a critically low hemoglobin (the oxygen carrying part of blood) which required the administration of several blood transfusions prior to determining the patient's blood type. During the second transfusion, the donor blood unit was incorrectly identified as uncross matched blood [O- blood type] by the placement of a bright orange sticker on the blood bag by Staff D. This, along with additional system errors, resulted in the patient being administered O+ blood instead of the intended O- blood type.

The FDA (Food and Drug Administration) Code of Federal Regulations, Title 21 Part 606 (Current good manufacturing practice for blood and blood components), Subpart G- Additional labeling standards for blood and blood components, Section 606.121 Container label, last revised on 4/1/2020, states in part,

"b. ...the label may be altered to indicate the proper name of the product, with any appropriate modifiers and attributes, and other information required to identify accurately the contents of a container after blood components ...have been prepared.

During surveyor interview with the Director of Laboratory Services on 7/22/2021 at 12:38 PM, she stated that, in speaking with Staff D, the staff member who released the blood from the Blood Bank, he stated that there were 2 units of blood in the Blood Bank refrigerator awaiting release, and, in haste, when the ED called for the second unit of blood for Patient ID #1, he inadvertently removed the O+ blood that was prepared for another patient and signed it out to Patient ID #1 without verifying the blood was O+. He also placed the bright orange colored uncross matched blood sticker on the donor blood bag which identified the blood as O-. This error, along with nursing errors, resulted in Patient ID #1, who remained with an unknown blood type, receiving approximately 50-125 cc's (cubic centimeters) of O+ blood instead of the intended O- blood.