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Based on document review, medical record review, observation and interview, the hospital failed to ensure measures were implemented to ensure the safe delivery of blood products to all patients in the hospital by failing to ensure staff correctly identified blood types for patients in the laboratory and at the patient's bedside for 1 of 1 (Patient #1) patients who received the wrong blood type transfusion.

The failure of the hospital to ensure staff correctly and accurately identified the blood type of patients prior to receiving a blood transfusion placed all patients in a SERIOUS and IMMEDIATE threat of their health and safety and for the potential of serious adverse occurences including death.

The findings included:

1. The hospital failed to ensure all patients received care in a safe setting by the failure of the hospital staff in the laboratory and the nursing department failing to correctly and accurately identify the blood type of patients. Once the failure was identified and recognized by Laboratory administration, there were no process changes to ensure patients would not receive the wrong blood type. Laboratory staff re-education was on conducted until after the surveyor requested interventions during the onsite visit on 10/14/19.
Refer to A 0144.

Based on standards of practice, policy review, document review and interview the hospital failed to ensure laboratory staff correctly and carefully identified the check between patient and blood components to avoid potentially fatal miss-transfusions for 1 of 3 (Patient #1) sampled patients who received the wrong blood transfusion type.

The findings included:

1. A review of Lippincott Manual of Nursing Practice 10th edition revealed, "STANDARDS OF CARE GUIDELINES...Blood Transfusion...When administering whole blood components, ensure the following...Ensure proper blood product is given to the right patient by verifying at least two identifiers (eg, [for example] full name and date of birth) with patient, blood product, and original order...Stop transfusion and notify patient's health care provider...if signs of reaction or other abnormalities occur...Be aware of delayed reactions and educate patient on risk and what to look for: hemolytic, iron overload, graft-versus-host disease, hepatitis, and other infectious diseases..."

2. Review of The Journal of International Federation of Clinical Chemistry and Laboratory Medicine (JIFCC) revealed, "...diagnostic errors appear to be the most common, most costly and most dangerous of medical mistakes both in inpatients and outpatients...Failure in the application of laboratory test results are major contributors to diagnostic errors, along with residual problems in test performances (analytical errors)...Therefore, the main message is the need to improve the quality of laboratory services, avoiding errors and improving patient safety...".

Review of a study published in the Archives of Pathology and Laboratory Medicine revealed, "...specimen labeling errors account for 55.5% of identification errors in the lab...Specimen labeling errors continue to threaten all healthcare facilities, no matter their size or amount of specimens processed. No laboratory is immune to the damaging effects yielded by specimen labeling errors... Improving patient safety and reducing specimen errors continue to be top priorities among laboratories...Mislabeled, unlabeled, or incomplete specimen labels often go unnoticed, generating damaging repercussions for your laboratory. Shedding light on such an important and widespread issue will help your facility gain awareness, so tools can be employed to help reduce specimen labeling errors...".

3. The facility's "Blood Administration Policy" revealed a transfusion compatibility chart for the transfusion of red blood cells for a recipient (patient) with O negative blood is only compatible and can only accept O negative blood from a donor. The policy stated, "...Match the blood or blood component to the order to transfuse and match the blood or blood component at the bedside ...the patient's identification process...patient's name... blood type ...".

4. The facility's "Component Check Out Process" policy revealed, "...Units (blood) should be dispensed from the blood bank by a lab tech and a licensed nurse...If lab personnel are unavailable, two licensed nurses are required for the release of the product..."

5. Medical record review for Patient #1 revealed an admission date of 9/27/19 for scheduled bilateral shoulder surgery. Pre-surgery laboratory (lab) tests were drawn and completed by the hospital on 9/24/19.

Review of the hospital's lab tests history card for Patient #1 revealed the patient's blood type was O negative. The blood type was verified by 2 blood draws in the hospital's laboratory on 9/24/19.

Patient #1 was taken to surgery on 9/27/19.
Review of the Anesthesia record dated 9/27/19 for Patient #1 revealed anesthesia was started at 9:07 AM by the Certified Registered Nurse Anesthetist (CRNA).
At 10:10 AM the CRNA documented the patient's blood loss was discussed with the surgeon and a decision was made to administer 1 unit of packed red blood cells (PRBCs). The hospital's lab department was notified to type and cross match I unit of PRBCs.

Review of a form titled "Orders" dated 9/27/19 revealed a physician's order for the hospital's Blood Bank to prepare 1 unit of PRBCs to be transfused as soon as possible in preparation for major surgery for Patient #1. There was a stamped notation tiled "Unit Check Out Information" on the order form. Lab Tech #1 completed the information on the stamped "Unit Check Out Information" by hand writing the donor type for Patient #1 as O positive, and also documenting Patient #1's blood type as O positive. The hand written initials revealed the unit was released by the lab at 10:40 AM by Lab Tech #1.

Review of the Anesthesia record for Patient #1 revealed at 11:21 AM one unit of PRBCs was hung and started infusing into Patient #1. The CRNA documented at 11:31 AM the blood transfusion was stopped due to the surgical nurse found a blood type discrepancy. There was no documentation in the CRNA note of how much blood Patient #1 had received during the blood transfusion or how the surgical nurse had found an error in the blood type.

Review of the Orthopedic Operative Note dated 9/27/19 revealed Patient #1 did not experience any complications during surgery. The operative note did not reveal that the wrong blood type was administered to Patient #1.

Review of the surgical nurse's notes revealed no documentation the patient had received the wrong blood type during surgery.

5. Observations of the unit of PRBCs that was administered to Patient #1 revealed in large bold letters the blood type was O Positive.

6. Review of the facility's Investigation of Transfusion Reaction dated 9/27/19 revealed the blood product for Patient #1 was returned to the blood bank at 12:00 PM. The report documented that approximately 100 milliliters (mls) of the wrong blood type had been administered to Patient #1. The report revealed there were no clerical errors on the history cards, work-up log book, sign-out log book and container label. The report revealed additional information was needed if there was a clerical error or discrepancy.
Review of the additional information revealed, "Tech looked back at incorrect line on log book when checking patient type. An O positive unit was pulled from inventory, crossmatch performed and was compatible. Surgery nurse caught the discrepancy in previously reported patient type and unit being given."
Review of additional comments revealed, "Spoke with [Named Physician] at 12:05 PM-Instructed to perform transfusion reaction investigation, but no further actions needed to be taken since it was a known clerical error."

There was no documentation provided by the facility of any process changes or education for the lab to ensure the wrong blood would not be pulled, delivered and administered to patients until after the surveyor onsite investigation.

7. In an interview on 10/7/19 at 10:30 AM in the board room, the Director of Quality was asked if the patient was told they had received the wrong blood type. The Director of Quality didn't know the answer and stated the surgeon had retired since then. The Director of Quality stated that on 9/27/19 at 12:05 PM a text message had been sent to her phone that the patient had received the wrong blood type.

In an interview on 10/7/19 at 1:30 PM in the board room the Chief Nursing Officer (CNO) stated the Licensed Practical Nurse (LPN #1) was in the surgery room and somehow knew the patient was O negative. The CNO stated, "because [LPN #1] herself was O negative".
The CNO stated the LPN cannot remember how she knew this.

In an interview on 10/7/19 at 2:14 PM in the board room LPN #1 was asked about Patient #1's surgery course and LPN #1 stated, "I did not know Patient #1 but from what I could recall, there was some mention of the patient's blood type".
LPN #1 stated after the blood arrived in surgery, RN #1 and the CRNA checked the blood and then the blood was started transfusing into Patient #1.
LPN #1 stated once the blood was transfusing LPN #1 had handed the surgeon an instrument and looked up at the blood that was transfusing in to Patient #1 and noticed the blood type on the bag was O positive.
LPN #1 stated I said, "Something's not right."
LPN #1 stated I turned to RN #1 and told the RN that Patient #1's blood type was O negative and asked RN #1, "Right?"
LPN #1 stated RN #1 went to the computer and verified Patient #1's blood type was O negative.
LPN #1 stated the CRNA then stopped the blood immediately and gave Patient #1 Benadryl. LPN #1 stated RN #1 then called the hospital's lab to report the error.

In an interview on 10/7/19 at 2:28 PM in the board room the CNO stated the CRNA and RN #1 were asked if Patient #1 had a blood bank armband on and the CNO stated both the CRNA and RN had confirmed that Patient #1 did have all the armbands on her ankle because both of the patient's shoulders were being operated on.
The CNO stated the lab does the type and crossmatches and the label was generated from the lab and it has to be on the patient for 48 hours.
The CNO stated when the first unit of blood was delivered to surgery, all the labels matched and there was no way for the 2 nurses to know the lab had sent the wrong type because everything matched. The CNO stated all the information was double checked and the armband was checked and everything matched.

In an interview on 10/8/19 at 10:05 AM the CNO was asked if expectations were for the CRNA to enter in the medical record about the 100 mls of O positive blood that was transfused into Patient #1 in error and the CNO stated the CRNA did not document the volume transfused because at the time (during the surgery) the CRNA did not know the volume of blood the patient had been administered. The CNO stated she thought it was put in a note somewhere.

In an interview on 10/8/19 at 10:30 AM in the board room RN #1 was asked to describe the events in surgery regarding Patient #1. RN #1 stated the lab staff had delivered the blood to herself and the CRNA. RN #1 verified they both (the CRNA and RN #1) had checked the blood.
RN #1 stated the CRNA was checking the blood and RN #1 had the yellow sheet with the form that had Patient #1's information on it.
RN #1 stated after reading from the yellow sheet, the CRNA would check the blood and the patient's armband.
RN #1 stated a "time out" was also performed and read from the computer.
RN #1 stated the patient's blood type was not announced during the time out. RN #1 stated the blood type was not stated in a time out.
RN #1 was asked if anyone had verified the patient's blood type out loud prior to administering the blood and the RN stated no knowledge of anyone saying the patient's blood type as O negative.
RN #1 verified LPN #1 was the one who stated Patient #1 had O negative blood.
RN #1 stated the blood transfusion was stopped immediately.
RN #1 stated after the blood was stopped, RN #1 looked in the computer and saw that Patient #1's blood type was O negative.

In a telephone interview on 10/21/19 at 1:48 PM the CRNA confirmed a lab technician brought the blood into surgery and gave it to the RN #1. The CRNA confirmed both RN #1 and the CRNA had checked the blood. The CRNA stated the red sticker on the blood bank armband was checked with the sticker on the blood bag, checked the unit number, and expiration date and everything was correct. The CRNA then stated, "I spiked the bag [inserted tubing into the bag] and hung it".
The CRNA stated Patient #1's vital signs were fine, "I documented in the computer what time I started it [blood transfusion]."
The CRNA stated I had not used the EPIC (hospital's computer software) scan in this hospital to hang blood before. The CRNA stated, "It was a total of 4 clicks, the number, expiration date and blood type."
The CRNA stated after the blood was transfusing into Patient #1, the scrub tech (LPN #1) stated out loud "Isn't the patient O negative? That's O positive, the patient is O negative."
The CRNA stated the blood transfusion was stopped immediately and the blood was disconnected. The CRNA stated, "I also stopped it in the computer [entered the time]."
The CRNA stated RN #1 called the lab immediately.
The CRNA stated Patient #1 was asymptomatic (Symptoms of blood transfusion reactions include back pain. dark urine. chills. fainting or dizziness. fever. flank pain. skin flushing - the patient was asleep from anesthesia and couldn't complain of symptoms).
The CRNA stated Benadryl 50 milligrams was administered intravenously to Patient #1 immediately (Benadryl is administered to treat blood transfusion reactions)..

In an interview on 10/21/19 at 2:07 PM the CNO and the Director of the Lab confirmed the laboratory education began after the initial survey exit date of 10/14/19 and not at the time the incorrect blood administration incident had been identified.

In the exit interview on 10/22/19 at 2:40 PM the CNO stated, "...Anyone can pick up blood [from the lab]..."

Based on medical record review, facility document review and interview, the facility failed to ensure drugs and biologicals were administered as ordered by a physician for 1 of 3 (Patient #2) sampled patients reviewed for blood transfusions.

The findings included:

Medical record review for Patient #2 revealed an admission date of 6/21/19 for severe anemia. Patient #2 was sent directly from the Primary Care Physician's office with orders for blood transfusions.

Review of the physician order dated 6/21/19 revealed, "Dx [Diagnosis] Severe Anemia. Type cross & transfuse iii [3] units of PRBC's [Packed Red Blood Cells]...Lasix 20 mg. IV [intravenous] between 1st & 2nd unit..."

Review of the Medication Administration Record (MAR) revealed Lasix 20 mg. IV, was administered on 6/21/19 at 10:15 PM.

Review of the transfusion flowsheet revealed the first unit of blood was transfused beginning on 6/21/19 at 10:05 PM and stopped on 6/22/19 at 1:15 AM. The 2nd unit of blood was transfused beginning on 6/22/19 at 1:45 AM.

In an interview on 9/7/19 at 12:31 PM in the board room, the CNO was asked if the Lasix was given between the 1st and 2nd unit of blood administered to Patient #2. The CNO confirmed the Lasix for Patient #2 was administered at the wrong time and was as medication error.