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Based on Staff interview and record review, it was determined the facility was not in compliance with the Condition of Participation for Quality Assurance and Performance Improvement (QAPI) at 42 CFR 482.21 related to patients who are at risk for adverse blood transfusion reactions, specifically for one patient who experienced an adverse transfusion reaction (patient#5) on 12/23/13 and subsequently died. This reaction occurred with one of 10 sampled patients.

The findings include:

The facility's Quality Assessment and Performance Improvement Program failed to identify and address the nursing staff failure to monitor and act as per facility protocol for patient (#5) with an adverse transfusion reaction. The RN Charge Nurse failed to supervise and evaluate the nursing care for each patient (A0395), the facility failed to ensure blood transfusions were administered in accordance with staff policies and procedures (A0409), and the RN who administered the blood transfusion to Patient #5 failed to recognize signs and symptoms of a blood reaction and failed to furnish services in accordance with the hospital's policies and procedures (A0410). Please refer to the Condition of Participation at 42 CFR 482.23, Nursing Services (A 385) for further details.

In addition, the laboratory quality assessment and performance improvement program failed to identify the cause of a blood bank testing error resulting in a transfusion reaction and subsequent death of 1 sampled patient (#5), and could not determine if the error that was made was due to an error in entering the data in the computer or if the medical technologist performed the test incorrectly.
Because the laboratory's quality assessment and performance improvement program failed to identify the cause of the testing error, the laboratory does not meet the Condition of Participation laboratory services. Please refer to the Condition of Participation for Laboratory Services at 42 CFR 482.27 (A0576).

Based on interview, clinical record review, and the review of policies and procedures, it was determined the facility failed to have an organized nursing services department that furnishes care to meet the needs of all patients. One of 10 sampled patients sustained a blood transfusion reaction on 12/23/13 that wasn't identified by nursing staff. Due to the facility's failure to identify the signs and symptoms of a transfusion reaction a patients medical condition deteriorated and the patient expired on 12/24/13.

Due to the findings, it was determined on 1/14/14, the facility has ongoing immediate jeopardy and the health and safety of patients receiving blood transfusions is at risk.

The finding included:

1. The facility failed to supervise and evaluate the nursing care for each patient. Refer to (A0395).

2. The facility failed to ensure blood transfusions were administered in accordance with staff policies and procedures. Refer to (A0409).

3. The facility failed to recognize signs and symptoms of a blood reaction and failed to furnish services in accordance with the hospital's policies and procedures. Refer to (A410).

Based on interviews and record reviews, it was determined the facility failed to ensure the Registered Nurse supervised and evaluated the care of 1 one of 10 sampled patients (Patient #5), who was receiving a blood transfusion on 12/23/13. At least 2 Registered Nurses failed to identify the signs and symptoms of a blood transfusion reaction. Due to this failure the nursing staff on the unit continued to allow an incompatible unit of blood to be transfused into a patient. This allowed the patients medical status to deteriorate to a critical status and the patient expired on 12/24/13.

Due to the findings, it was determined on 1/14/14, the facility has ongoing immediate jeopardy and the health and safety of patients receiving blood transfusions is at risk.


The findings include:

During record review, it was determined sampled patient # 5 had a history of Iron Deficient Anemia. The patient underwent a total knee replacement on 12/9/13 at another hospital. The patient was transferred to this hospital/facility on 12/23/13 from a local rehabilitation center due to a low Hemoglobin of (6.9) and Hematocrit of (23.0).
The patient was admitted to the Medical/Peds/Oncology unit on 12/23/13 at approximately 1530 hours. The patient was to receive 2 units of packed red blood cells during the admission.
The medical record was reviewed with the Risk Manager (RM) and Registered Nurse(#1) on 1/10/14 at 1:00PM. The following was noted in the medical record.
The patient's nursing care plan dated 12/23/13 documented:
The patient will tolerate blood transfusion and Medical Doctor (MD) will be notified of any adverse reactions.

A pre- infusion temperature was documented at 1733 hours on 12/23/13 and was 99.1 degree's Fahrenheit (F). The blood pressure (B/P) was documented as 154/73.
The first unit of Packed Red Blood Cells (PRBC) was initiated by RN (#1) at 1748 hours. The patient's temperature was documented as 99.1 F at 1758 hours.
At 1750, a call was placed to the physician by the RN Charge Nurse requesting an order for Tylenol.
RN (#)1 reported, at 1:00 PM on 1/10/14, the Tylenol was requested as a prophylaxis for a fever or headache. RN (#1) documented, Tylenol 325 milligrams (mg.) 2 tablets was administered at 1858 hours on 12/23/13.
At 1810 hours, the patients temperature was 99 degrees F.
At 1907 hours, the RN Charge Nurse placed a call to the physician for an order for Benadryl intravenously (IV). The physician ordered, Benadryl 12.5 mg. Intravenously (IV). The IV Benadryl was administered at 1916 hours by RN (#1). When asked, why the patient received Benadryl, RN (#1) stated, "Because she had the chills."
The nurses observation of the patient having chills was not identified as a sign and symptom of a blood transfusion reaction.

The RM stated, on 1/10/14 at 1:10 PM, she was unaware the patient was administered Benadryl for chills.
The Clinical Record Documentation recorded at 1930 hours by RN #1 revealed:
During the first unit of PRBC the patient complained of chills, and had an oral temperature of 100.2 F. The physician was notified and Tylenol and Benadryl were administered. Afterwards, there was an oral temp of 99.2 F. There was clear yellow urine in the Foley catheter bag.
It was noted, the temperature of 100.2 F was not documented in the Bar code enabled Transfusion Administration (BCTA) process as occurring during the transfusion. The
patient's temperature recorded in the BCTA system throughout the transfusion was 99 - 99.7 degrees F.

At 2100 on 12/23/13, a Licensed Practical Nurse (LPN) documented the following: Urinary Appearance: Hematuria and Urinary Symptoms: Bloody. Bruising is noted on the patient's skin. The patient is forgetful and restless. The unit of PRBC was documented as completed at 2130 hours. The LPN documented the patient was alert.
The signs and symptoms of hematuria and bruising were not identified as signs and symptoms of a blood transfusion reaction by the nursing staff.

At 0008 hours on 12/24/13, the patient's heart rate was 130 - 150 beats/minute. The rhythm was documented as Atrial Fibrillation. The RN Charge Nurse notified the LPN of the increased heart rate.
The next documentation of the patient's condition made by the LPN was entered at 0045 hours on 12/24/13, Patient resting in bed. Patient transferred to Intensive Care Unit (ICU) bed 10. Patient transferred with personal belongings. Report given to ICU.
While in the ICU on 12/24/13, a pulmonology consult was completed. The pulmonologist documented the multiple diagnoses for patient #5 to include:
?Transfusion Reaction, Disseminated Intravascular Coagulation (DIC), Acute Kidney Injury, Respiratory Failure, Severe Metabolic Acidosis, Permanent Atrial Fibrillation, Hyperkalemia secondary to acute kidney injury and acidosis, and abnormal liver function test.
A Do Not Resuscitate physicians order was written at 1847 hours on 12/24/13. The patient expired at 2143 hours on 12/24/13.

During interview at 1:00PM on 1/10/14, RN (#1) stated, the doctor was notified of the patient's temperature. RN (#1) stated she did not think it was a reaction. The nurse reported, Chemo patients usually have chills when receiving blood. It was noted, patient #5 was not receiving Chemotherapy. The RN stated, the Charge Nurse was placing the calls to the physician.

During the review of the facility's Policy and Procedure titled Blood and Blood Products Administration and Refusal (dated 10/2013) the following was noted:
Procedure: Any unfavorable change in the patient's condition immediately upon initiation, during or within several hours or more after the transfusion will be considered a possible adverse reaction to the blood or blood component. Refer to Lippincotts Nursing Policy and Procedure (P&P) and Skills for the management of blood reactions.
Lippincotts Blood and blood products transfusion:
Signs and symptoms of complications:
Vague uneasy feeling
Onset of pain (at IV site, back or chest)
Chills
Flushing
Fever
Nausea
Dizziness
Rash
Itching
Dark or red urine
If a reaction occurs, immediately stop the transfusion and notify the doctor.
It was noted, the nursing staff did not follow this facility policy.
At the time of the survey, the medical record lacked documentation that the signs and symptoms demonstrated by the patient were reported to the RN Charge Nurse.
The medical record lacked documentation of supervision of RN #1 and the LPN by the RN Charge Nurse to ensure the patient was not having a blood transfusion reaction and that the needs of the patient were evaluated to ensure appropriate nursing care and services had been provided to patient #5.

Based on clinical record review, interview and review of policies and procedures, it was determined the facility failed to ensure the protocol was followed related to incompatibility or allergic reactions for 1 of 10 sampled patients (Patient #5) whom received a blood transfusion.

Due to the findings, it was determined on 1/14/14, the facility has ongoing immediate jeopardy and the health and safety of patients receiving blood transfusions is at risk.

The findings include:

During the review of the facility's Policy and Procedure titled Blood and Blood Products Administration and Refusal (dated 10/2013) the following was noted:
Procedure: Any unfavorable change in the patient's condition immediately upon initiation, during or within several hours or more after the transfusion will be considered a possible adverse reaction to the blood or blood component. Refer to Lippincotts Nursing Policy and Procedure (P&P) and Skills for the management of blood reactions.
Lippincotts Blood and blood products transfusion:
Signs and symptoms of complications:
Vague uneasy feeling
Onset of pain (at IV site, back or chest)
Chills
Flushing
Fever
Nausea
Dizziness
Rash
Itching
Dark or red urine
If a reaction occurs, immediately stop the transfusion and notify the doctor.

During record review, it was noted sampled patient # 5 received one unit of Packed Red Blood Cells (PRBC) on 12/23/13.
The first unit of blood unit of Packed Red Blood Cells (PRBC) was initiated by RN (#1) at 1748 hours.

The patient exhibited an elevated temperature, shaking chills, and Hematuria during the transfusion which lasted from 1748 hours to 2130 hours. The patient was administered Benadryl and Tylenol within the first hour of the transfusion. The 350 ml unit of PRBC was infused and completed at 2130 hours.

RN (#1) stated at 1:00 PM on 1/10/14, an order for Tylenol was requested as a prophylaxis for fever or headache. RN (#1) documented Tylenol 325 milligrams (mg.) 2 tablets was administered at 1858 hours on 12/23/13.

At 1907 hours, the RN Charge Nurse placed a call to the physician for an order for Benadryl intravenously (IV). The physician ordered Benadryl 12.5 mg. Intravenously (IV). The Benadryl was administered at 1916 hours by RN (#1). When asked why the patient received Benadryl, RN (#1) stated, "Because she had the chills."
RN #1 and the RN Charge nurse failed to identify the signs and symptoms exhibited by the patient were a blood transfusion reaction. The nursing staff failed to stop the blood transfusion to prevent a negative outcome for patient #5. The staff failed to follow the facility's policy and procedure for Blood and Blood Product Administration.

The Clinical Record Documentation recorded at 1930 hours by RN #1 revealed:
During the first unit of PRBC the patient complained of chills, and had an oral temperature of 100.2 F. The physician was notified and Tylenol and Benadryl were administered. Afterwards, there was an oral temp of 99.2 F. There was clear yellow urine in the Foley catheter bag.
It was noted, the temperature of 100.2 F was not documented in the Bar code enabled Transfusion Administration (BCTA) process as occurring during the transfusion. The
patient's temperature recorded in the BCTA system throughout the transfusion was 99 - 99.7 degrees F.

At 2100 on 12/23/13, a Licensed Practical Nurse (LPN) documented the following: Urinary Appearance: Hematuria and Urinary Symptoms: Bloody. Bruising is noted on the patient's skin. The patient is forgetful and restless. The unit of PRBC was documented as completed at 2130 hours. The LPN documented the patient was alert.
The signs and symptoms of hematuria and bruising were not identified as signs and symptoms of a blood transfusion reaction by the nursing staff.

At 0008 hours on 12/24/13, the patient's heart rate was 130 - 150 beats/minute. The rhythm was documented as Atrial Fibrillation. The RN Charge Nurse notified the LPN of the increased heart rate.
The next documentation of the patient's condition made by the LPN was entered at 0045 hours, Patient resting in bed. Patient transferred to Intensive Care Unit (ICU) bed 10. Patient transferred with personal belongings. Report given to ICU.

The patient was transferred to a higher level of care due to the deterioration of her medical condition.
While in the ICU on 12/24/13, a pulmonology consult was completed. The pulmonologist documented the multiple diagnoses for patient #5 to include:
?Transfusion Reaction, Disseminated Intravascular Coagulation (DIC), Acute Kidney Injury, Respiratory Failure, Severe Metabolic Acidosis, Permanent Atrial Fibrillation, Hyperkalemia secondary to acute kidney injury and acidosis, and abnormal liver function test.
A Do Not Resuscitate physicians order was written at 1847 hours on 12/24/13. The patient expired at 2143 hours on 12/24/13.

Based on interviews, clinical record reviews and review of policy and procedures, it was determined the facility failed to ensure nursing staff were familiar with and complied with the hospital's policies related to the recognition of an adverse blood reaction for 1 of 10 sampled patients whom received a blood transfusion.

Due to the findings, it was determined on 1/14/14, the facility has ongoing immediate jeopardy and the health and safety of patients receiving blood transfusions is at risk.


The findings include:

During the review of the facility's Policy and Procedure titled Blood and Blood Products Administration and Refusal (dated 10/2013) the following was noted:
Procedure: Any unfavorable change in the patient's condition immediately upon initiation, during or within several hours or more after the transfusion will be considered a possible adverse reaction to the blood or blood component. Refer to Lippincotts Nursing Policy and Procedure (P&P) and Skills for the management of blood reactions.
Lippincotts Blood and blood products transfusion:
Signs and symptoms of complications:
Vague uneasy feeling
Onset of pain (at IV site, back or chest)
Chills
Flushing
Fever
Nausea
Dizziness
Rash
Itching
Dark or red urine
If a reaction occurs, immediately stop the transfusion and notify the doctor.

The medical record was reviewed with the Risk Manager (RM) and Registered Nurse(#1) on 1/10/14 at 1:00PM.
During record review, it was noted sampled patient # 5 received one unit of Packed Red Blood Cells (PRBC) on 12/23/13.
The first unit of blood unit of Packed Red Blood Cells (PRBC) was initiated by RN (#1) at 1748 hours.

The patient exhibited an elevated temperature, shaking chills, and Hematuria during the transfusion which lasted from 1748 hours to 2130 hours. The patient was administered Benadryl and Tylenol within the first hour of the transfusion. The 350 ml unit of PRBC was infused and completed at 2130 hours.

It was noted during record review, these signs and symptoms were not recorded in the Bar Code Enabled Transfusion Administration (BCTA) process as symptoms of a blood reaction. If the symptoms had been record in the BCTA system, this would have given a warning signal to the nursing staff, (temp above 99.7) and prompted a question: Are you sure you want to transfuse?
Each time a vital sign is entered into the BCTA, the signs/symptoms of a possible transfusion reaction goes to the Transfusion Reaction policy and procedure. If the reaction is identified, the facility's protocol is to shut off the blood and notify the physician and lab.

Patient #5's nursing plan of care related to Anemia/Blood Transfusion documented: The patient will tolerate blood transfusion and MD will be notified of any adverse reactions.

During interview with the Risk Manager on 1/9/14 at 12:00PM, it was stated, the problem was with the laboratory unit not with nursing.

It was noted, RN #1 and the RN Charge nurse failed to identify the signs and symptoms exhibited by the patient were a blood transfusion reaction. The nursing staff failed to stop the blood transfusion to prevent a negative outcome for patient #5. The staff failed to follow the facility's policy and procedure for Blood and Blood Product Administration.

Based on a review of records and staff interview during the Clinical Laboratory Improvement Act (CLIA) complaint survey, it was determined the laboratory's quality assessment and performance improvement program failed to identify the cause of a blood bank testing error resulting in a transfusion reaction and subsequent death of 1 of 10 sampled patient (#5). The facility was found to be out of compliance with the Condition of Particiation for Laboratory Services at 42 CFR 482.27.

Due to the findings, it was determined on 1/14/14, the facility has ongoing immediate jeopardy and the health and safety of patients receiving blood transfusions is at risk.

The Findings include:


Review of documentation revealed on 12/23/2013 a 2 unit cross match was ordered for patient (#5) in the emergency room. A blood typing and antibody screen was performed on the blood specimen, accession # 1223:XG:BB000265. The antibody screen was positive and subsequently the laboratory identified the patient had two red blood cell antibodies. The antibodies were identified as, anti-big E (the E antigen is part of the RH antigen system) and anti-JKa (the JKa antigen is part of the Kidd antigen system).

Due to the presence of the two red cell antibodies, any packed red blood cell units that the patient might be given had to be pre-screened in order to determine that the red blood cells did not have either the big E antigen and the JKa antigen. Based on the information, the laboratory screened multiple units in an effort to identify the units that were compatible with the patient.

On December 23, 2013, a unit, # W038113326927, was determined to be compatible and was transfused into the patient. The patient developed a transfusion reaction to the unit and therefore the laboratory performed a transfusion reaction work up per the laboratory procedure.

Based on the results of the post transfusion work up, the medical technologist that performed the original red cell antigen screening made a laboratory error, which resulted in the patient receiving a unit of packed red cells that had the JKa antigen. Because the patient was given a unit of pack red blood cells that had the JKa antigen, the patient had a reaction to the transfused unit and later expired on 12/24/13.

Based on the review of laboratory records and interview with supervisory staff on the day of the survey, the laboratory's quality assessment program could not determine if the error that was made was due to an error in entering the data in the computer or if the medical technologist performed the test incorrectly.

Because the laboratory's quality assessment and performance improvement program failed to identify the cause of the testing error, the laboratory does not meet the Condition of Participation for laboratory systems.