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Based on staff interview, record review and document review, the hospital's Governing Body (GB) failed to provide the necessary oversight in order to ensure patient safety and quality healthcare.

1. The hospital failed to enact a quality improvement program in the laboratory blood bank to revise and update their policies and procedures (P&P) to reflect current practices. This failure caused a lack of safeguards which resulted in Patient 1 receiving a mismatched unit of blood. (Refer to A-0263 and A-0283)

2. The hospital laboratory blood bank failed to establish, maintain and update blood banking P&P's in order to ensure patient safety, which resulted in the release of a mismatched unit of blood to Patient 1. (Refer to A-0576 and A-0583)

The cumulative effects of these systemic failures resulted in the hospital's failure to maintain the effectiveness of its GB.

Based on staff interview, record review and document review, the hospital's Governing Body (GB) failed to provide the necessary oversight in order to ensure patient safety and quality healthcare.

1. The hospital failed to enact a quality improvement program in the laboratory blood bank to revise and update their policies and procedures (P&P) to reflect current practices. This failure caused a lack of safeguards which resulted in Patient 1 receiving a mismatched unit of blood. (Refer to A-0283)

2. The hospital laboratory blood bank failed to establish, maintain and update blood banking P&P's in order to ensure patient safety, which resulted in the release of a mismatched unit of blood to Patient 1. (Refer to A-0576 and A-0583)

The cumulative effects of these systemic failures resulted in the hospital's failure to maintain the effectiveness of its GB.

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Based on staff interview, record review and document review, the hospital failed to identify opportunities for improvement and set priorities for performance improvement activities as demonstrated by the continued use of outdated policies and procedures (P&P) in the hospital blood bank (BB). (Refer to A0583)

Findings:

During a tour of the BB on 1/26/16 at 10:20 a.m., when the senior clinical lab scientist (SCLS) was asked about the P&P for the type and cross match for emergency transfusion of blood, she pointed to a set of binders. The binders contained P&P's, some written in 1999, titled with the former name of the hospital, and signed by the Governing Body as reviewed on a biennial (every other year) basis to date, but without any revisions.

Six of six reviewed BB policies and procedures (Blood Components, 2009; HIV LookBack and Notification of Recipients, 1/2014; Non-emergent Blood Product Administration, 4/2015; Transfusion Reaction Protocol, 8/2014; and Blood Transfusion Reaction, 6/ 2014) did not reflect the current practice in the BB, contained references to outdated sources, and did not match current manufacturer's instructions.

The P&P for the emergency release of blood did not contain current community standards for patient safety, such as verifying results by testing a second specimen. The outcome of this failure to identify the need for updating the BB P&P's caused an error in blood typing and the infusion of mismatched blood to (Patient 1).

On 1/28/16 at 10 AM, the BB Medical Director (LMD) stated they are in the process of revising many of the Laboratory P&P's in order to reflect current standards of best practices. When asked why these revisions were so late in being done and not acted on earlier, she stated she was not the medical director then and had recently been appointed to the position.

In interviews, on 1/28/16 at 12:20 PM, the Medical Laboratory Manager (MLM) and the LMD, the MLM stated the BB tracks critical laboratory values, monitors for expired reagents use for blood testing, and reviews hand hygiene practices for infection control. However, the MLM and LMD were unable to provide supporting documentation of an active Quality Assurance and Performance Improvement program that focused on the BB's prevention of the potential for transfusion related incidents.

The Condition of Participation for Laboratory Services is not met as evidence by the hospital's failure to be in compliance with Part 493 of the Condition as evidenced by:

1. Ensure that staff were adequately trained and competent to perform independent emergency blood type and screen tests (TAS) to meet emergency transfusion needs. (Refer to A-0583)

2. Develop a policy and procedure (P&P) for staff to follow when there were no blood type history for type and cross-matching [the test that is performed prior to a blood transfusion in order to determine if the donor's blood is compatible with the blood of an intended recipient]. (Refer to A-0583)


3. Develop a P&P for how to safely issue, in emergency situations, type specific units of blood. (Refer to A-0583)

4. Review and revise the Blood Bank's P&P's according to current standards of practice and approved by the lab's Medical Director. (Refer to A-0583)

The cumulative effect of these system failures resulted in the failure to have an effective process to provide safe delivery of blood bank services to patients.


The Federal Code of Regulations, Part 493, General laboratory systems assessment, 493.1239:

(a) "the laboratory must establish and follow written polices and procedure for ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems."



The Federal Code of Regulations, Part 493, 493.1251, Standard: Procedure Manual:
"(d) Procedures and changes in procures must be approved, signed and dated by the current director before use."

Based on staff interviews, record review, and document review, the hospital failed to ensure the Laboratory's Blood Bank (BB) operations were provided in accordance to Federal law, current policy and procedures, and acceptable standards of practice for one (Patient 1) of 20 sampled patients. This failure resulted in the transfusion of mismatched blood to Patient 1 due to lack of a standardized process to type and cross match a blood sample to meet the emergency needs of the patient.

Findings:

Patient 1, a 29 year old male, presented to the hospital Emergency Department (ED) on 12/1/15 at 9 PM, complaining of weakness and shortness of breath. Patient 1 medical history included alcohol dependence, and chronic headaches.

Initial blood tests revealed severe anemia with a hemoglobin (a measurement of the RBC iron content) of 2.4 grams (normal is 12-15 grams). Soon after Patient 1's arrival in the ED, he sustained a cardiac arrest. Patient 1's blood type was unknown, and a blood sample was sent to the lab for emergency blood typing and cross (the test that is performed prior to a blood transfusion in order to determine if the donor's blood is compatible with the blood of an intended recipient) match for blood products. Two units of O negative blood (the universal blood type compatible with all blood types) were transfused while waiting for the type specific units of blood identified during the type and cross-match.

The BB sent the two units of type AB positive blood to the ED to be transfused to Patient 1. After the infusion of the first unit of blood, the BB notified the ED to stop the infusion, because the blood type and cross matching was incorrect, and that Patient 1 should have received a A positive blood instead of the AB positive being infused.

The second unit on AB positive blood was returned to the BB. No signs or symptoms of a transfusion reaction was detected, during the transfusion of the incorrect typed blood unit (AB positive) as Patient 1 was in cardiac arrest (the sudden, unexpected loss of heart function, breathing and consciousness).


Patient 1 was resuscitated, intubated (tube placed in the windpipe to assist with breathing for patients) placed on a ventilator for assisted breathing, and transferred to the Intensive Care Unit (ICU). Blood samples were obtained from Patient 1 to test for possible transfusion reaction.

The samples were evaluated by the Laboratory pathologist (individual who specializes in diagnostic tests), and the findings reported as a "hemolytic reaction" (destruction of RBC's which occurs with mismatched blood). Patient 1 died on 12/7/15 with multi-organ failures; no autopsy was performed per the family's instruction.

The Code of Federal Regulations, Part 493, General laboratory systems quality assessment, §493.1239 (a) "The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems."

During a review of the BB P&P's on 1/26/16, many of the policies were originals created in 1999 with every other year re-approval; however there were no revisions made to the original documents written in 1999. Subsequent to Patient 1's transfusion mismatch, a new P&P was created, titled "Emergency Release of Blood," dated 12/29/15, with significant changes in the testing and release of blood products. On 1/28/16 at 10 AM, the lab Medical Director (LMD) stated, "this is the way we want to do it to ensure there are no further mistakes".

Code of Federal Regulations Part 493, 493.1251; Standard: Procedure Manual:"(d) Procedures and changes in procures must be approved, signed and dated by the current director before use."

Inspection of the P&P manual on 1/26/15, revealed all the policies and procures in use in the BB were signed by the former Medical Director.

On 1/28/16 at 9 A.M., the certified lab scientist (CLS 1) stated she was working in the Laboratory's urinalysis section when she received a call on 12/1/15 requesting emergency blood products for Patient 1, and offered to assist in performing the emergency type and screen (TAS).

(Blood type tests are done before a person gets a blood transfusion. Human blood is typed by certain markers (called antigens) on the surface of red blood cells (RBC's). The most important antigens are blood group antigens (ABO).
The ABO test shows that people have one of four blood types: Type A, Type B, Type AB, or Type O. Type O negative blood does not have any AB antigens, and is called the "universal donor" because it is compatible with any blood type. Type A individuals produce anti-B antibodies that attack Type B blood. Blood received in a transfusion must have the same antigens as yours (compatible blood). If you get a transfusion that has different antigens (incompatible blood), the antibodies in your plasma (liquid portion of the blood) will destroy the donor blood cells. This is called a transfusion reaction. A transfusion reaction can be mild or cause a serious illness and even death. Reference: "Blood Transfusions" www.webmd.com www.webmd.com ;" Harrison ' s Principles of Internal Medicine, " 18th edition; page 951).

CLS 1 stated she was not comfortable with the manual TAS method, but did not inform anyone in the lab concerning her discomfort. CLS 1 stated she performed the manual TAS screen process for as follows:

(a) One drop of the Patient 1's plasma was placed into specimen tubes (4) and (5) of five specimen tubes. This grouping involves reacting the corresponding patient 's blood with known A and B cells to identify the antibodies present.

(b) All five test tubes were placed in the centrifuge (spins tubes causing the heavy particles like RBC 's to settle to the bottom of the tube) machine for 30 seconds.

(c) The five test tubes were removed from the centrifuge. Tubes (1), (2), and (3), were placed in the first row of the holding rack, and tubes (4) and (5) into the second row of the holding rack.

(d). Recorded the reaction of Patient 1's reaction in all five tubes was recorded onto the BB's spreadsheet for ABO/Rh antibody screening (which was in a specific order for documentation).

CLS 1 recorded tube (2) as a positive reaction and tube (4) as a negative reaction on the spreadsheet, and determined Patient 1 had Type AB, positive blood.

In concurrent interviews, on 1/27/16 at 3:40 PM, the GLT stated she performed a cross match test (serves as a final check of ABO compatibility) of Patient 1's blood TAS, and her results differed from those of CLS 1. Supervisor CLS 3 stated she repeating the test to verify GLT's results. The new results revealed tube (2) was negative and tube (4) was positive (opposite of CLS 1's findings) and identified Patient 1 had Type A positive blood.

CLS 1 stated she observed other staff doing the TAS, but had not performed the manual TAS test under emergent conditions before, and could not explain how the error occurred. When asked what she would do differently, CLS 1 stated she would check the labels on the tubes.

On 1/28/16 at 9:45 AM, the Senior CLS (SCLS) stated she provided CLS 1's training, and discussed the emergent TAS, but did not conduct an actual return demonstration before issuing her competency. SCLS stated CLS 1 had performed one emergent TAS under direct supervision.

According to SCLS, the "Transfusion Reaction" take-home quiz given to CLS 1's to evaluate knowledge and understanding of possible transfusion reactions was never returned to SCLS for grading. Of note, the header of the quiz provided by SCLS to CLS 1 reflected the hospital's name as licensed in 1998, not the current name of the hospital, and did not reflect the current BB standards of practice.

On 1/26/16 at 10:20 AM, the SCLS demonstrated the manual method of emergent TAS testing currently used in the BB. GLS 1's procedure deviated in emergent TAS practice as follows:

a. The labeled specimen tubes were placed in two rows and not arranged sequentially in the same row as demonstrated.

b. One drop of Patient 1 's plasma was added to tubes (4) and (5), and the demonstrated procedure required two drops.

c. The specimen tubes were centrifuged for 30 seconds and not as 15-20 seconds as stated by the SCLS. (The "Transfusion Service Centrifuge Calibration," dated 11/12/15 indicated the optimum centrifuge time is 20 seconds).

d. Tubes removed from the centrifuge were not placed into the holding rack in sequential order for reading and recording results onto the BB spreadsheet.

Record review on 1/27/16 of the BB's policy and procedure dated 12/ 2009, "Emergency Release of Blood," reflected there was no procedure for staff to follow in the event there was no prior history of a patient's blood type in an emergency situation.

The P&P dated 10/2011, "Emergency Issue of Blood," lacked the critical steps for performing an emergency TAS, and had no reference for the interpretation of TAS results, including when and how to verify testing.

Based on staff interviews, record review, and document review, the hospital failed to ensure the Laboratory's Blood Bank (BB) operations were provided in accordance to Federal law, current policy and procedures, and acceptable standards of practice for one (Patient 1) of 20 sampled patients. This failure resulted in the transfusion of mismatched blood to Patient 1 due to lack of a standardized process to type and cross match a blood sample to meet the emergency needs of the patient.

Findings:

Patient 1, a 29 year old male, presented to the hospital Emergency Department (ED) on 12/1/15 at 9 PM, complaining of weakness and shortness of breath. Patient 1 medical history included alcohol dependence, and chronic headaches.

Initial blood tests revealed severe anemia with a hemoglobin (a measurement of the RBC iron content) of 2.4 grams (normal is 12-15 grams). Soon after Patient 1's arrival in the ED, he sustained a cardiac arrest. Patient 1's blood type was unknown, and a blood sample was sent to the lab for emergency blood typing and cross (the test that is performed prior to a blood transfusion in order to determine if the donor's blood is compatible with the blood of an intended recipient) match for blood products. Two units of O negative blood (the universal blood type compatible with all blood types) were transfused while waiting for the type specific units of blood identified during the type and cross-match.

The BB sent the two units of type AB positive blood to the ED to be transfused to Patient 1. After the infusion of the first unit of blood, the BB notified the ED to stop the infusion, because the blood type and cross matching was incorrect, and that Patient 1 should have received a A positive blood instead of the AB positive being infused.

The second unit on AB positive blood was returned to the BB. No signs or symptoms of a transfusion reaction was detected, during the transfusion of the incorrect typed blood unit (AB positive) as Patient 1 was in cardiac arrest (the sudden, unexpected loss of heart function, breathing and consciousness).


Patient 1 was resuscitated, intubated (tube placed in the windpipe to assist with breathing for patients) placed on a ventilator for assisted breathing, and transferred to the Intensive Care Unit (ICU). Blood samples were obtained from Patient 1 to test for possible transfusion reaction.

The samples were evaluated by the Laboratory pathologist (individual who specializes in diagnostic tests), and the findings reported as a "hemolytic reaction" (destruction of RBC's which occurs with mismatched blood). Patient 1 died on 12/7/15 with multi-organ failures; no autopsy was performed per the family's instruction.

The Code of Federal Regulations, Part 493, General laboratory systems quality assessment, §493.1239 (a) "The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems."

During a review of the BB P&P's on 1/26/16, many of the policies were originals created in 1999 with every other year re-approval; however there were no revisions made to the original documents written in 1999. Subsequent to Patient 1's transfusion mismatch, a new P&P was created, titled "Emergency Release of Blood," dated 12/29/15, with significant changes in the testing and release of blood products. On 1/28/16 at 10 AM, the lab Medical Director (LMD) stated, "this is the way we want to do it to ensure there are no further mistakes".

Code of Federal Regulations Part 493, 493.1251; Standard: Procedure Manual:"(d) Procedures and changes in procures must be approved, signed and dated by the current director before use."

Inspection of the P&P manual on 1/26/15, revealed all the policies and procures in use in the BB were signed by the former Medical Director.

On 1/28/16 at 9 A.M., the certified lab scientist (CLS 1) stated she was working in the Laboratory's urinalysis section when she received a call on 12/1/15 requesting emergency blood products for Patient 1, and offered to assist in performing the emergency type and screen (TAS).

(Blood type tests are done before a person gets a blood transfusion. Human blood is typed by certain markers (called antigens) on the surface of red blood cells (RBC's). The most important antigens are blood group antigens (ABO).
The ABO test shows that people have one of four blood types: Type A, Type B, Type AB, or Type O. Type O negative blood does not have any AB antigens, and is called the "universal donor" because it is compatible with any blood type. Type A individuals produce anti-B antibodies that attack Type B blood. Blood received in a transfusion must have the same antigens as yours (compatible blood). If you get a transfusion that has different antigens (incompatible blood), the antibodies in your plasma (liquid portion of the blood) will destroy the donor blood cells. This is called a transfusion reaction. A transfusion reaction can be mild or cause a serious illness and even death. Reference: "Blood Transfusions" www.webmd.com www.webmd.com ;" Harrison ' s Principles of Internal Medicine, " 18th edition; page 951).

CLS 1 stated she was not comfortable with the manual TAS method, but did not inform anyone in the lab concerning her discomfort. CLS 1 stated she performed the manual TAS screen process for as follows:

(a) One drop of the Patient 1's plasma was placed into specimen tubes (4) and (5) of five specimen tubes. This grouping involves reacting the corresponding patient 's blood with known A and B cells to identify the antibodies present.

(b) All five test tubes were placed in the centrifuge (spins tubes causing the heavy particles like RBC 's to settle to the bottom of the tube) machine for 30 seconds.

(c) The five test tubes were removed from the centrifuge. Tubes (1), (2), and (3), were placed in the first row of the holding rack, and tubes (4) and (5) into the second row of the holding rack.

(d). Recorded the reaction of Patient 1's reaction in all five tubes was recorded onto the BB's spreadsheet for ABO/Rh antibody screening (which was in a specific order for documentation).

CLS 1 recorded tube (2) as a positive reaction and tube (4) as a negative reaction on the spreadsheet, and determined Patient 1 had Type AB, positive blood.

In concurrent interviews, on 1/27/16 at 3:40 PM, the GLT stated she performed a cross match test (serves as a final check of ABO compatibility) of Patient 1's blood TAS, and her results differed from those of CLS 1. Supervisor CLS 3 stated she repeating the test to verify GLT's results. The new results revealed tube (2) was negative and tube (4) was positive (opposite of CLS 1's findings) and identified Patient 1 had Type A positive blood.

CLS 1 stated she observed other staff doing the TAS, but had not performed the manual TAS test under emergent conditions before, and could not explain how the error occurred. When asked what she would do differently, CLS 1 stated she would check the labels on the tubes.

On 1/28/16 at 9:45 AM, the Senior CLS (SCLS) stated she provided CLS 1's training, and discussed the emergent TAS, but did not conduct an actual return demonstration before issuing her competency. SCLS stated CLS 1 had performed one emergent TAS under direct supervision.

According to SCLS, the "Transfusion Reaction" take-home quiz given to CLS 1's to evaluate knowledge and understanding of possible transfusion reactions was never returned to SCLS for grading. Of note, the header of the quiz provided by SCLS to CLS 1 reflected the hospital's name as licensed in 1998, not the current name of the hospital, and did not reflect the current BB standards of practice.

On 1/26/16 at 10:20 AM, the SCLS demonstrated the manual method of emergent TAS testing currently used in the BB. GLS 1's procedure deviated in emergent TAS practice as follows:

a. The labeled specimen tubes were placed in two rows and not arranged sequentially in the same row as demonstrated.

b. One drop of Patient 1 's plasma was added to tubes (4) and (5), and the demonstrated proced