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.

REGIONAL ONE HEALTH 877 JEFFERSON AVENUE MEMPHIS, TN 38103 March 2, 2016
VIOLATION: NURSING SERVICES Tag No: A0385
Based on facility policy review, document review, medical record review and interview, the facility failed to ensure all nursing staff followed policies and procedures for labeling collected blood samples with the correct patient identity in order to prevent transfusion reactions and failed to ensure nursing documented and reported laboratory reporting of a transfusion reaction to staff and physicians.
The facility's failure to ensure staff followed the blood sample identification policy and reported significant laboratory findings of a blood transfusion reaction to staff and the patient's physician resulted in a SERIOUS AND IMMEDIATE THREAT to the health and safety of Patient #1 and placed all patients in IMMEDIATE JEOPARDY.

The findings included:

1. The facility failed to ensure all nursing staff identified patients correctly, labeled blood samples per facility policy, and documented and reported significant findings of a blood transfusion reaction to staff taking care of the patient and to the patient's physician.
Refer to A392
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy review, document review, medical record review, observation and interview, the Registered Nurse (RN) failed to supervise nursing care provided to patients who had blood samples drawn and labeled to ensure the blood samples were drawn from the correct patient and labeled with the correct patient's name for 1 of 1 (Patient #1) sampled patient who received the wrong blood products. Nursing failed to evaluate each patient when alerted by the laboratory department of potential life threatening issues such as hemolysis and blood transfusion reactions and document and notify the staff and physicians taking care of the patient for 1 of 1 (Patient #1) sampled patients who received the wrong blood products resulting in hemolysis.
The nursing's failure to correctly identify all patients, label blood samples according to the hospital's policy, and provide appropriate nursing interventions when notified of potential life threatening issues resulted in a SERIOUS AND IMMEDIATE THREAT to the health and safety of Patient #1 and placed all patients in IMMEDIATE JEOPARDY.

The findings included:

1. Review of the facility's "Patient Identification Measures" policy that was in effect on 12/7/15 revealed, "...To ensure that all patients are properly identified prior to care and treatment...Patient identification must be confirmed using the two-identifier system prior to administration of medication, transfusion of blood or blood products, obtaining blood or other specimens from the patient..."

Review of the facility's "Labeling Blood Specimens" policy that was in effect on 12/7/15 revealed, "...All Specimens must be labeled at the patient's bedside immediately after collections. Note: For patient safety purposes do not label a specimen that you did not draw..."

Review of the facility's "Blood Transfusion Reaction" policy that was in effect on 12/7/15 revealed, "...Nursing staff shall follow a hospital-wide procedure for the recognition and treatment of transfusion reactions...Obtain vital signs and document in the transfusion record. Notify the physician of symptoms and vitals immediately and ask if a reaction work-up is needed...When a transfusion reaction is called, no further blood products will be issued until the serological investigation is completed by the Transfusion Service...
The Transfusion Service investigates all reported adverse reactions to blood transfusion on the order of the physician...A final written report will be made after review by the Transfusion Service Medical Director...
ADVERSE REACTION TO TRANSFUSION It is important to note that reactions to the transfusion of blood and blood components may occur immediately, at any time during the transfusion, or several hours or even days after the transfusion. Understanding this temporal quality is important in the recognition of various types of transfusion reactions...
ACUTE [DIAGNOSES REDACTED] TRANSFUSION REACTIONS [HTRs]...The classic example of this type is that of an ABO incompatible transfusion [when people who have one type of blood type receive blood from someone with a different type, it may cause their immune system to react]...In anesthetized patients who cannot report symptoms, the manifestations may be limited to diffuse bleeding...the mortality exceeds 40 percent. Acute HTR's are more often due to clerical error, that is misidentification either by administration of blood to the wrong person or the wrong blood to the intended recipient...These misidentification errors are entirely preventable when proper procedure for identification and administration is used.
Signs and Symptoms...Fever...Chills...Chest pain/lower back pain...Hypotension...Nausea...Flushing...Dyspnea...Hemoglobinuria/oliguria/anuria/acute renal failure...Diffuse bleeding/DIC [Disseminated Intravascular clotting]...
Prevention/Treatment...depends on the amount of incompatible blood transfused the antibody specificity and the clinical severity of the reaction. Primary concerns are...hypotension...renal blood flow...
DELAYED [DIAGNOSES REDACTED] TRANSFUSION REACTIONS...are perhaps more difficult to recognize as they tend [to] become evident one to three weeks after transfusion...hemolysis will result from the combination of high antibody level and large numbers of transfused cells in the circulation...
Signs and Symptoms...Fever...Anemia...Mild jaundice...Positive DAT/presence of spherocytes on blood smear...Less likely are...Hemoglobinuria (acute renal failure is uncommon)...Hypotension...DIC..."

Review of the "Transfusion Reaction Investigation" policy that was in effect on 12/7/15 revealed, "All Adverse reactions to transfusions must be reported to the Transfusion service and the reaction investigated to the extent considered appropriate by the medical director...Note: If there is mis-administration of a blood product or other system failure, the Medical Director must be notified for investigation and resolution of the error...4a. When the initial testing is completed call results to the nurse in charge of the patient, 4b. Record on the Transfusion Reaction Investigative Worksheet the name of the person called, tech [technician] initials, and the date and time the results were reported..."

2. Medical record review revealed Patient #1 was a [AGE] year old involved in a motor vehicle collision (MVC) on 12/7/15 and was ejected approximately 300 feet from the vehicle. The patient was transported per ambulance to the Level 1 Trauma emergency room (ER). The patient arrived at the ER at 10:15 and was placed in Shock Trauma Room #1 along with Patient #3.

Review of the 12/7/15 "Shock Trauma Flowsheet" revealed a Type and Screen laboratory (lab) blood test [to determine the patient's blood type] was ordered for Patient #1. A Resident Physician drew a blood sample from both Patient #1 and from Patient #3. ER Technician #1 entered the patients' room and labeled both the blood samples with both Patient #1 and Patient #2's name on each blood sample.
At 11:12 AM the lab called the Shock Trauma ER and requested a re-draw of the blood sample specimens due to each blood sample had both patient's names on them.

Before the blood sample re-draw was obtained, Patient #1 was transferred at 11:14 AM to radiology for tests. At this time Patient #2 arrived at the ER and was placed in the room with Patient #3. The Resident Physician entered the patients' room and re-drew the blood sample from Patient #2 and left the blood sample on a table in the patient's room. The ER technician entered the room and asked the nurse who's blood sample was on the table. The nurse told the ER Technician it was the blood sample of Patient #1. The ER Technician labeled the blood sample with Patient #1's name and sent it to the lab to be processed. The re-drawn sample determined Patient's #1 blood type was B positive.

3. Patient #1's CT scan "was suggestive of a possible splenic laceration; therefore, we [the physicians] have elected to take him back to the OR [operating room] for exploratory laparotomy..." The patient was transferred from the CT scan room to the Trauma OR.

The "Anesthesia Intraop [intraoperative] Record" revealed Patient #1's surgery began at 1:06 PM and ended at 3:17 PM. The 12/7/15 Trauma and Orthopedic operative reports revealed the following:

During the Trauma OR Patient #1 received 2 units of O Pos red tag emergency cells and 1 unit of B Pos RBCS blood during surgery. The report revealed, "...He [Patient #1] had hemodynamic instability...with tachycardia and labile blood pressure...", and an exploratory laparotomy, repair of transverse colon serosal tear x2 and a cecal serosal tear procedures were performed. The report revealed, "...There did not appear to be any bleeding coming from this area [spleen]..."
The Orthopedic report documented 8 procedures were performed to the left open femur fracture, left open calcaneus fracture, left tibia and left lisfranc fracture-dislocation.
Post surgeries the patient was transferred to Trauma intensive care unit in "...critical condition..."

On 12/8/15 the patient was transferred back to surgery for another operation. The Trauma "Report of Operation" report revealed the patient's blood count had dropped and the patient was taken back to surgery due to suspected bleeding. The operative report revealed, "...Exploratory laparotomy...on routine repeat laboratory studies he [Patient #1] was found to have a hematocrit of 12 [normal being 40 - 50]. He was transfused 4 additional units of packed red blood cells [type B blood] and taken back to the OR for exploratory laparotomy for presumed intraabdominal bleeding...there was nothing actively bleeding at this time we elected to close the patient...The patient was taken back to the trauma ICU [intensive care unit] in critical condition..."

4. Review of the 12/8/15 physician's "Progress Report" revealed the patient had been placed on a ventilator and was sedated with Fentanyl and Versed. The physician documented, "...Acute post-traumatic hypoxic respiratory failure...S/P [status post] re-exploration overnight with no significant bleeding...Acute post-hemorrhagic anemia...S/P [status post] massive transfusion yesterday...Monitor Hct...vent mgmt [ventilator management]..." The patient remained on the ventilator throughout his hospitalization .

Review of the 12/11/15 physician's "Progress Report" revealed, "...Patient with continued drop in hematocrit...Hct 22.2 S/P [status post] 2U [units]PRBC [packed red blood cells, type B Positive]...mixed [DIAGNOSES REDACTED], dark urine, continued anemia with no obvious source of bleeding, heme [Hematology] consult pending..."
Record review revealed on 12/11/15 the patient received a total of 7 units of B Positive RBCS.

Review of the 12/11/15 Hematology consultation notes revealed, "...Jaundiced....Icteric...No evidence of hemolysis..."

Review of the 12/13/15 physician's progress note and hematology reports addressed the patient's hemolysis and condition as follows:

The 12/13/15 Hematology consult notes documented, "...Acute Anemia...No clinically evident source of bleeding identified. While there is concern for hemolysis, current labs aren't necessarily revealing of a [DIAGNOSES REDACTED] process. That is not to say that there is not a [DIAGNOSES REDACTED] component or that hemolysis is not possible in the future..."

The 12/13/15 physician's "Progress Report" documented, "...Continued hemolysis, transfused 7 units of blood [B positive] past 24 hours. Worsening bilirubinemia [46.4]...HCT 13.4 [down from 17.3] - after PRBCs-hematology following for ongoing hemolysis..."

During a telephone interview on 3/1/16 at 4:00 PM MD #3 was asked about the 12/13/15 note documenting "continued...ongoing hemolysis." Physician #3 stated stated he felt like it was going to be hemolysis related to the multiple transfusions, anemia and the increased bilirubin level. The physician stated he treated the patient as if it were hemolysis and discussed plasmapheresis. Physician #3 stated he had not spoken to the Hematologist. The physician stated he felt like it was going to be hemolysis because he'd never seen a patient's bilirubin rise as rapidly as it had with this patient.
Review of the patient's Bilirubin lab levels revealed the following high levels (normal 0.2 milligrams per deciliter mg/d) :
12/10/15 - 15.8 mg/dl.
12/11/15 - 17.3 mg/dl.
12/12/15 - 46.4 mg/dl.
12/14/15 - 71.1 mg/dl.
12/15/15 - 74.4 mg/dl.

Review of the 12/14/15 physician's "Progress Report" revealed, "...Received 1U PRBCs [type B blood] and 4U FFP [type B blood] over last 24 hours. Total 31 PRBCs [ type B blood], 16 FFP [type B and AB blood], 30 buttons platelets...concern of ongoing hemorrhage. No active hemorrhage seen...Hematology consulted for massive hemolysis..."

Review of a 12/14/15 progress note written at 1545 (3:45) revealed a Code Blue (cardiopulmonary resuscitation (CPR) note which documented, "...patient became bradycardic [slow heartbeat] and lost a pulse...Chest compressions started...patient had ROSC [return of spontaneous circulation]"

5. On 12/15/15 at 5:00 AM Medical Technologist (MT) #1 documented she notified Nurse #1 who was in charge of Patient #1's care that an investigation for a blood transfusion reaction was being initiated by the laboratory due to tests indicated the patient's blood samples showed signs of hemolysis and the patient's plasma was black in color (normal clear-yellow). There was no evidence the nurse who received the lab report regarding the transfusion reaction investigation and hemolysis documented the report or notified the patient's physician of the hemolysis or blood transfusion reaction investigation being performed by the laboratory department. There was no documentation the nurse performed an assessment of the patient for a possible blood transfusion reaction. Nurse #1 left the hospital after his 7:00 AM shift ended. There was no documentation Nurse #1 notified the incoming nurses of the patient's hemolysis or a blood transfusion reaction investigation was being performed by the laboratory for Patient #1.

Review of the 12/15/15 nursing clinical notes reports revealed at 7:00 AM "Pt's [patient's] heart rate and blood pressure drops suddenly...HCT [hematocrit] is critically low and pt is actively bleeding..." There was no other documentation of a nursing assessment for a potential blood transfusion reaction or physician notification,

6. Review of the 12/16/15 physician's "Progress Report" revealed, "...continue mechanical ventilation...Patient was found to have received blood products of the incorrect blood type...Pathology following. Patient may need plasmapheresis...Acute renal failure-continue CRRT [Continuous Renal Replacement Therapy]...Patient on levophed and vasopressin at this time [for blood pressure support]..."

Review of the 12/17/15 Hematology note revealed, "...Yesterday noted pt typed as B+ [positive] when actually O+ [positive]...Ultimately found to have blood mismatch...Anemia initially 2/2 [secondary to] blood loss, then hyperhemolysis from major mismatch (ABO)..."

Review of the "Transfusion History" report revealed from 12/7/15 - 12/14/15 Patient #1 received approximately 73 units of the wrong type of blood and blood products as follows:
12/7/15- 5 units of type B red blood cells (RBCs) and 6 units of B Fresh Frozen Plasma (FFP).
12/8/15- 6 units of type B RBCS, 2 units of B Apheresis and 4 units of type B FFP.
12/9/15- 4 units of type B FFP, 4 units of type B FFP and 1 unit of type B Apheresis.
12/11/15- 4 units of type B RBCs.
12/12/15- 5 units of type B RBCs.
12/13/15- 10 units of type B RBCS.
12/14/15- 10 units of type B RBCs and 12 units of type B FFP.

After the discovery of the blood sample error, review of the "Transfusion History" report revealed from 12/15/15 - 12/31/15 Patient #1 received approximately 51 units of type O transfusions of blood and blood products.

Review of the 12/26/15 physician's progress report revealed, "...Patient emergently bronch'ed [bronchial scope] last night due to suspicion of mucous plug in right lung...Trach canceled...due to...instability...subcutaneous emphysema..."

Review of the 1/2/16 physician's progress report revealed the patient was having Supra[DIAGNOSES REDACTED] (SVT - an abnormal heartbeat) and
required the use of cardioversion (an electric shock in order to return normal heartbeat) twice.

Review of the 1/3/16 physician's progress report revealed, "...Worsening sepsis overnight with increased pressor requirements...Patient made DNR [Do Not Resuscitate]...Patient maxed out on vasopressor support...worsening septic shock..."

Review of the 1/3/16 physician progress note revealed written at 12:25 revealed "...Called to bedside by RN [Registered Nurse]. Patient noted to be in asystole [without a heartbeat]...Pt pronounced dead at 12:24..."


7. Review of the Blood Bank "Time Line of Events for [name of Patient #1]" revealed on 12/15/15, "...Another T & S [type and screen] was drawn and the blood bank [laboratory] discovered that the patient's plasma had gross hemolysis [black in color]..." Medical Technologist (MT) #1 called Patient #1's nurse who was RN #1, "...to inquire about the patient's clinical situation..." At this time, MT #1 told the RN #1 the patient's plasma was black in color and that this looked like a transfusion reaction. RN #1 stated to MT #1 that the patient was lysing his red cells and the Hematologist had ruled out a blood transfusion reaction. (There was no documentation a Transfusion Reaction work-up had been ordered by the Hematologist to rule out a blood transfusion reaction). MT#1 notified the pathologist and blood bank manager. The Pathologist then decided to give only type O negative RBCS and type AB negative plasma products to the patient while an investigation continued. The timeline also revealed the blood bank was never made aware that Patient #1 was a previous patient with a different medical record number which revealed the patient was actually O Positive.

There was no documentation RN #1 notified the patient's physician of the lab notification of the patient's hemolysis and blood transfusion reaction or initiated a transfusion reaction worksheet investigation.

During an interview on 2/22/16 at 2:50 PM in the conference room the Director of Quality verified there was no documentation the RN notified the physician or initiated the transfusion reaction investigation worksheet.

Review of the physician's "Discharge Summary" revealed, "...The patient was admitted to the Trauma ICU [on 12/7/15]...the patient was noted to have a repeat hematocrit of 12.2...the patient was thought to have intra-abdominal hemorrhage after the exploratory laparotomy [12/7/15]...the patient was taken back to the operating room and re-explored...no significant bleeding was found...The patient over the next following days required significant blood product transfusions...The patient did not appear to be responding appropriately and approximately on hospital day 6 was noted to have become jaundiced with an increasing bilirubin...With a concern for hemolysis, a workup was initiated to identify a source...the patient continued to require significant transfusion and over the next several days was found to have an ABO incompatibility...this was addressed with pathology as well as Hematology...The patient...continued to worsen with a [DIAGNOSES REDACTED] process that led to significant [DIAGNOSES REDACTED]...developed worsening renal function requiring continuous renal replacement therapy...also requiring full ventilation which was not improving...Approximately 2 weeks into the patient's hospital stay, once the ABO incompatibility had been corrected, the patient did respond to blood products...the patient over the next week appears to have developed fungemia [The presence of fungi or yeast in the blood, seen in immunosupressed or immunocompromised patients seen with risk factors of broad spectrum antibiotics, dialysis, CVC, high severity illnesses, multiple abdominal surgeries and steroid use.] as well as a fungal UTI [Urinary Tract Infection] which lead to sespis syndrome...On the date of death , the family elected to make the patent comfort care with a DO NOT RESUSCITATE order...at 1224 [12:24 PM] hours on January 3, 2016 the patient expired..."

8. An interview was conducted on 2/8/16 at 10:00 AM in the conference room regarding the wrong blood transfusions for Patient #1. The Risk Manager, Chief Nursing Officer, Director of Quality, Chief Operating Officer, Laboratory Medical Director and the Administrative Director of Lab Services were present during the interview.

The Risk Manager stated there were 2 separate mislabeling episodes that occurred with Patients #1, #2 and #3. Patients #1 and #3 were in shock Trauma Room #1 at the same time. The initial blood lab specimens for Patient #1 and Patient #3 were mislabeled. Each of their blood sample specimens had 2 labels, 1 with Patient #1's name and 1 with Patient #3's name. The laboratory declined the mislabeled samples and called to have the samples redrawn.

The Risk Manager stated in the meantime the second mislabeling occurrence happened when Patient #1 went for a CT scan and Patient #2 was placed in the Shock Trauma bed that Patient #1 had previously been in. The physician obtained a blood sample per arterial stick on Patient #2 and that blood was left unlabeled on the table. ER Technician (Tech) #1 returned to the Shock Trauma Room, took Patient #2's unlabeled blood, labeled it with Patient #1's name and took the sample to the lab. Patient #2's blood sample was then processed as Patient #1's blood sample.

There was no documentation why the ER staff left an unlabeled blood sample lying on the table. There was no documentation why the ER Tech labeled a blood specimen that they did not draw or witness being drawn.

During an interview on 2/9/16 at 9:05 AM in the conference room Shock Trauma ER Tech #1 verified he went back into Shock Trauma Room #1 and there was an unlabeled blood specimen on the table. He stated the ER nurse informed him it was Patient #1's blood so he said he labeled it with Patient #1's name and took the sample to the lab for testing. Shock Trauma ER Tech #1 stated he did not recall the nurse's name who had informed him the blood specimen sample belonged to Patient #1.

During an interview on 2/9/16 at 10:00 AM in the conference room Physician #1, who was Patient #1's trauma physician, stated he supervised the Resident Physicians who obtained blood specimen samples and had supervised the blood drawing specimen samples drawn on 12/7/15 for Patients #1 and #2. Physician #1 verified the correct procedure for collecting blood samples specimen was for the Resident Physicians to obtain the blood sample specimen from the patient's arterial sticks by using a syringe and then the Resident Physicians were supposed to hold up the collected blood sample syringe up in the air for a staff member to take it, place it in the appropriate lab tube and label it with the correct patient's name.

During an interview on 2/22/16 at 3:00 PM in the conference room Trauma ICU RN #1 stated he collected the type and screen blood sample for Patient #1 on 12/15/15 but did not recall being notified by the lab with any concerns. RN #1 stated the patient was bleeding from orifices.

During an interview on 2/22/16 at 4:15 PM in the conference room the Medical Director of Blood Bank Services stated, "Yes" the patient had a transfusion reaction. The Medical Director provided Blood Bank notes that revealed, "...12/15/15...Patient is incompatible with B Pos [positive]RBCS...Patient's plasma is extremely icteric and black in color...Hematology is consulting on this case....Per [Name of Medical Director] Give O Negative RBCS and AB FFP' Only!!!!!! Give type AB negative or O Negative Platelets."

During an interview on 2/23/16 at 8:10 AM in the conference room MT #1 stated she had performed the type and screen testing on 12/15/15. She stated that she received the blood sample at approximately 4:00 AM. She stated the tests indicated hemolysis, she viewed the plasma and it was black in color. At around 5:00 AM she stated she notified the patient's nurse RN #1 and informed him the patient's tests looked like he was having a blood transfusion reaction. She stated RN #1 informed her that the Hematologist had ruled out a blood transfusion reaction. MT #2 then stated she notified her laboratory Medical Director and Blood Bank Manager. There was no documentation in the medical record the Hematologist had ruled out a blood transfusion reaction.

Record review revealed a "Transfusion Reaction Investigation Worksheet" report was not completed until 2/23/16. The report revealed when the reaction was identified on 12/15/15, MT #1 reported the findings to RN #1. RN #1 reported the patient was experiencing decreased blood pressure and bleeding. The report, signed off by the Medical Director, revealed the patient experienced a "[DIAGNOSES REDACTED] transfusion reaction due to ABO incompatibility."

4. Review of the facility's investigation revealed the following problems identified:

The specimen labeling process failed contributing to the blood hand-off process to fail in the Shock Trauma Room.

Medical staff failed to follow procedure for the hand-off of blood specimen collection. Only 1 technician was available at the time for 3 Shock Trauma patients.

Roles, Responsibilities and Positioning of individuals in the room during trauma cases. Multiple trauma patients arriving within a short timeframe.

Review of the facility's action plan to address the identified problems during the investigation were as follows:

To address the front end registration process and chain of custody for specimens. The "...Front end process to be implemented within 60 days. Chain of custody process by [DATE]."

To address staff contingency plan, training, establish improved visual controls, establish responsibility matrix for Shock Trauma Room.
Some "visual controls" were implemented on 12/21/15. A staff meeting was held on 1/14/16, with implementation initiated on 1/14/16. The "Responsibility matrix presented to the Trauma Committee 2/18/16" and implementation on 3/1/16.

To address multiple trauma arriving in a short timeframe was to establish one-piece flow processes and identify resources to call for surge or max capacity process or policy. This was to be implemented in "60 days."

To perform employee coaching of blood collection policy and 2 staff signatures verifying all blood specimens. This action was implemented on 12/21/15 with remaining staff on 1/14/16.

To address the chain of custody of blood specimen and responsibility matrix a chain of custody plan was to be implemented by the week of 1/22/16. The responsibility matrix was to be (MDS) dated [DATE] and implemented on 3/1/16.

The plan identified the ED Director and Manager were responsible for the action plan. The plan documented to conduct audits, direct observations, roundings and post-trauma debriefings to determine if the plan was being implemented. The date to measure and identify the effectiveness was "To be determined."

An interview was conducted on 2/23/16 at 12:30 PM to discuss the corrective action plan with the ED Director, Risk Manager, Director of Quality, Chief Nursing Officer and ED Manager all present.
The Risk Manager stated the visual controls were implemented on 12/21/15 with the 2 beds in the Shock Trauma Rooms #1 and #2 being labeled as Bed #1 and Bed #2 signs placed above the stretchers and labeled bins affixed to the wall. The Risk Manager stated she became aware of the ABO incompatibility situation on 12/17/15.
The ED Director stated regarding the "surge or max capacity process...it's been discussed but not formalized yet."
The surveyor asked if the facility had evidence they had performed any audits, direct observations, roundings or post-trauma debriefings in accordance with the corrective action plan. The ED Nurse Manager stated, "No."
The surveyor asked for evidence that all the physician's had received inservices on the corrective action plans. The facility was unable to provide documentation that all ED physicians had been in-serviced on the corrective action plans.

There was no documentation the facility's corrective actions were implemented, monitored and or determined effective to ensure all patients were correctly identified, had correct blood samples specimens collected and labeled to ensure all patients received correct blood products to prevent blood transfusion reactions.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on policy review, record review and interview, the Governing Body failed to assume responsibility and provide oversight of the hospital's quality of care, QAPI program and medical staff. The failure of the Governing Body to assume responsibility and provide oversight resulted in a SERIOUS and IMMEDIATE THREAT to the health and safety of all patients and placed them in an IMMEDIATE JEOPARDY and at risk for serious injuries and/or death.

The findings included:

1. The Governing Body failed to ensure all policies were followed by the medical staff to ensure blood samples were obtained and labeled with the correct patient.
Refer to A049 and 392

2. The Governing Body failed to ensure the Quality Assessment Performance Improvement (QAPI) committee provided oversight and monitoring of their interventions to prevent blood transfusion errors.
Refer to A286

3. The Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible and ensured all blood transfusions were safely administered.
Refer to A392 and A057
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on facility policy, document review, record review and interview, the Governing Body failed to ensure Medical Staff accountability for the quality of care provided in order to prevent blood transfusion errors for 1 of 1 (Patient #1) sampled patients receiving blood transfusions.

The findings included:

1. Review of the hospital's policy, "Patient Identification Measures revealed, "...To ensure that all patients are properly identified prior to care and treatment...Patient identification must be confirmed using the two-identifier system prior to...obtaining blood or other specimens from the patient..."

2. Record review revealed Patient #1 was involved in a motor vehicle collision on 12/7/15 with multiple trauma. Patient #1 was put in the hospital's emergency room (ER) Trauma room with Patient #3. Resident hysicians, supervised by Physician #1 drew blood samples from both Patient #1 and Patient #3 via femoral arteries. Both blood samples were labeled with both Patient #1 and Patient #3 names on each of the samples and sent to the laboratory. The laboratory refused the samples and requested a re-draw.

Before the re-draw was obtained, Patient #1 was sent to radiology for a Computerized tomography (CT) scan. While Patient #1 was in radiology Patient #2 arrived at the hospital ER and was put in the same room with Patient #3.

On 12/7/15 at 10:56 AM a Resident Physician, supervised by Physician #1 obtained a blood sample drawn from the femoral artery of Patient #2 for a blood type and screen. The blood sample drawn from Patient #2 was left lying on a table in the patients' room. An ER technician entered the room, asked the nurse on duty whose blood sample it was, was told by the nurse it belonged to Patient #1, mislabeled the blood sample with Patient #1's identification label and submitted the blood sample to the lab.

There was no documentation the resident physician followed the hospital's policy and procedure for confirming the patient's identification using the two-identifier system prior to obtaining the blood sample, or why the blood sample was left on the table in the patients' room.

As a result of the mis-labeling of the blood sample, Patient #1 received multiple blood transfusions of the incorrect blood type and suffered an ABO incompatibility (an immune system reaction that occurs when you receive the wrong type of blood during a blood transfusion) [DIAGNOSES REDACTED] blood transfusion reaction.

Review of the 12/14/15 physician's "Progress Report" revealed, "...Received 1U PRBCs [type B blood] and 4U FFP [type B blood] over last 24 hours. Total 31 PRBCs [ type B blood], 16 FFP [type B and AB blood], 30 buttons platelets...concern of ongoing hemorrhage. No active hemorrhage seen...Hematology consulted for massive hemolysis..."

Review of the 12/17/15 Hematology note revealed, "...Yesterday noted pt typed as B+ [positive] when actually O+ [positive]...Ultimately found to have blood mismatch...Anemia initially 2/2 [secondary to] blood loss, then hyperhemolysis from major mismatch (ABO)..."

Review of the "Transfusion History" report revealed from 12/7/15 - 12/14/15 Patient #1 received approximately 73 units of the wrong type of blood and blood products as follows:
12/7/15- 5 units of type B red blood cells (RBCs) and 6 units of B Fresh Frozen Plasma (FFP).
12/8/15- 6 units of type B RBCS, 2 units of B Apheresis and 4 units of type B FFP.
12/9/15- 4 units of type B FFP, 4 units of type B FFP and 1 unit of type B Apheresis.
12/11/15- 4 units of type B RBCs.
12/12/15- 5 units of type B RBCs.
12/13/15- 10 units of type B RBCS.
12/14/15- 10 units of type B RBCs and 12 units of type B FFP.

Review of the 1/2/16 physician's progress report revealed the patient was having Supra[DIAGNOSES REDACTED] (SVT - an abnormal heartbeat) and
required the use of cardioversion (an electric shock in order to return normal heartbeat) twice.

Review of the 1/3/16 physician's progress report revealed, "...Worsening sepsis overnight with increased pressor requirements...Patient made DNR [Do Not Resuscitate]...Patient maxed out on vasopressor support...worsening septic shock..."

Review of the 1/3/16 physician progress note revealed written at 12:25 revealed "...Called to bedside by RN [Registered Nurse]. Patient noted to be in asystole [without a heartbeat]...Pt pronounced dead at 12:24..."

During an interview on 2/9/16 at 10:00 AM in the conference room MD #1, Patient #1's trauma physician, stated he supervises the Resident Physicians' who obtain the blood samples and had supervised the samples on 12/7/15 for Patients #1 and #2. He stated the samples were obtained from arterial sticks and then the Resident Physician should hold the sample up in the air for a staff member to take it for labeling.

Review of the facility's QAPI action plans/interventions to address the identified problems were inservice staff on the appropriate policies and procedures to identify patients, obtain lab samples and correctly label samples to prevent blood transfusion reactions errors.

An interview was conducted on 2/23/16 at 12:30 PM to discuss the corrective action plan with the ED Director, Risk Manager, Director of Quality, Chief Nursing Officer and ED Manager all present. The surveyor asked for evidence that all the physician's had received inservices/training on the corrective action plans/interventions. The facility was unable to provide documentation that all ER physicians had been in-serviced on the corrective action plans/interventions.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on policy review, record review, document review and interview, the Chief Executive Officer (CEO) failed to assume responsibility for the management of the hospital, ensure all staff followed policies and procedures for the identification of patients to prevent transfusion reactions and ensure the Quality Assessment Performance (QAPI) committee implemented and provided oversight to interventions to prevent blood transfusion reactions for 1 of 1 (Patient #1) sampled patients that received blood.
The failure of the CEO to assume responsibility for the management of the hospital and ensure all staff followed policies and procedures to correctly identify patients and that QAPI interventions for the prevention of blood transfusion reactions were implemented resulted in a SERIOUS AND IMMEDIATE THREAT to the health and safety of Patient #1 and placed all patients in IMMEDIATE JEOPARDY.


The findings included:

1. Review of the hospital's policy, "Patient Identification Measures revealed, "...To ensure that all patients are properly identified prior to care and treatment...Patient identification must be confirmed using the two-identifier system prior to...obtaining blood or other specimens from the patient..."

Review of the hospital's policy, "Labeling Blood Specimens", revealed, "...All specimens must be labeled at the patients' bedside immediately after collections. Note: For safety purposes do not label a specimen that you did not draw..."

2. Record review revealed Patient #1 was involved in a motor vehicle collision on 12/7/15 with multiple trauma. Patient #1 was put in the hospital's emergency room (ER) Trauma room with Patient #3. A resident physician, supervised by MD #1 and MD #4, drew blood samples from both Patient #1 and Patient #3 via femoral arteries. Both blood samples were labeled with both Patient #1 and Patient #3 names on each of the samples and sent to the laboratory. The laboratory refused the samples and requested a re-draw.

Before the re-draw was obtained, Patient #1 was sent to radiology for a Computerized tomography (CT) scan. While Patient #1 was in radiology Patient #2 arrived at the hospital ER and was put in the same room with Patient #3.

On 12/7/15 at 10:56 AM a resident physician, supervised by MD #1, obtained a blood sample drawn from the femoral artery of Patient #2 for a blood type and screen. The blood sample drawn from Patient #2 was left lying on a table in the patients' room. An ER technician entered the room, asked the nurse on duty whose blood sample it was, was told by the nurse it belonged to Patient #1, mislabeled the blood sample with Patient #1's identification label and submitted the blood sample to the lab.

There was no documentation the resident physicians and physicians followed the hospital's policy and procedure for confirming the patient's identification using the two-identifier system prior to obtaining the blood sample.

As a result of not following policies and procedures for drawing and labeling blood samples, Patient #1 received approximately 73 units of wrong type of blood transfusions from 12/7/15 to 12/14/15 which resulted in the patients sustaining an ABO incompatibility (an immune system reaction that occurs when you receive the wrong blood type during a blood transfusion) [DIAGNOSES REDACTED] blood transfusion reaction.

4. Review of the facility's QAPI action plan to prevent the recurrence of wrong patient blood transfusions revealed there was no documentation ensuring the plan was implemented and monitored. There was no documentation the ER physicians were educated on the intervention plans and monitored.

5. There was no documentation the CEO was actively involved to ensure the wrong blood transfusion incident was thoroughly investigated with appropriate interventions implemented and monitored to ensure all patients received blood in a safe manner.
VIOLATION: QAPI Tag No: A0263
Based on facility policy, document review, medical record review and interview, the facility failed to develop, implement and monitor an effective and ongoing hospital-wide quality assessment and performance improvement program (QAPI) to prevent blood transfusion reactions.
The failure of the facility's QAPI to ensure the implementation of interventions to prevent errors in labeling blood samples and blood transfusion reactions resulted in a SERIOUS and IMMEDIATE THREAT to the health and safety of all patients and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. The facility failed to ensure the QAPI program effectively implemented and monitored interventions related to obtaining blood samples and the labeling blood samples to prevent blood transfusion reactions
Refer to A286
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy, record review, document review and interview, the Quality Assessment Performance Improvement (QAPI) committee failed to ensure an ongoing hospital-wide program that identified contributing causes and implemented and monitored preventative interventions to prevent the occurrence of the wrong patient receiving the wrong blood transfusion for 1 of 1 (Patient #1) sampled patients who received blood transfusions.
The failure of the QAPI committee to ensure corrective interventions were implemented and monitored for obtaining and labeling blood samples resulted in a SERIOUS and IMMEDIATE THREAT to the health and safety of all patients and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. Medical record review revealed Patient #1 was a [AGE] year old involved in a motor vehicle collision (MVC) on 12/7/15 and was ejected approximately 300 feet from the vehicle. The patient was transported per ambulance to the Level 1 Trauma emergency room (ER). The patient arrived at the ER at 10:15 and was placed in Shock Trauma Room #1.

A type and screen blood sample was obtained on 12/7/15 and it was determined the patient's blood type was B Positive.

Review of the "Transfusion History" report revealed from 12/7/15 to 12/14/15 Patient #1 received approximately 73 units of type B blood and blood products related to repeated low hematocrit blood counts.

On 12/15/15 after a laboratory investigation due to Patient #1's blood was showing signs of hemolysis (a destruction or rupture of red blood cells), it was determined the patient's blood type was actually O Positive instead of B positive. On 12/15/15 at 5:00 AM Medical Technologist (MT) #1 documented she notified Nurse #1 who was in charge of Patient #1's care, of the initial laboratory investigation that reveled the patient's blood tests showed hemolysis and that Patient #1's plasma was black in color (normal clear-yellow) indicating a blood transfusion reaction. There was no documentation Nurse #1 notified the physician or in-coming nursing of the laboratory findings. There was no documentation Nurse #1 documented the laboratory findings.

Review of the Blood Bank "Time Line of Events for [name of Patient #1]" revealed on 12/15/15, "...Another T & S [type and screen] was drawn and the blood bank discovered that the patient's plasma had gross hemolysis (black in color)..." Medical Technologist (MT) #1 called Patient #1's nurse who was RN #1, "...to inquire about the patient's clinical situation..." At this time, MT #1 told the RN #1 that the patient's plasma was black in color and this looked like a transfusion reaction. RN #1 then told MT #1 that the patient was lysing his red cells and the Hematologist consult had ruled out a transfusion reaction. (There was no documentation a Transfusion Reaction work-up had ever been ordered by the Hematologist to rule out a blood transfusion reaction). MT #1 then notified the Pathologist and blood bank manager. The Pathologist decided to give only type O negative RBCS and type AB negative plasma products to the patient while the investigation continued. The timeline also revealed the laboratory blood bank was never made aware that Patient #1 was a previous patient with a different medical record number which revealed the patient was actually O Positive.

Review of the physician's "Discharge Summary" revealed, "...The patient was admitted to the Trauma ICU [on 12/7/15]...the patient was noted to have a repeat hematocrit of 12.2...the patient was thought to have intra-abdominal hemorrhage after the exploratory laparotomy [12/7/15]...the patient was taken back to the operating room and re-explored...no significant bleeding was found...The patient over the next following days required significant blood product transfusions...The patient did not appear to be responding appropriately and approximately on hospital day 6 was noted to have become jaundiced with an increasing bilirubin...With a concern for hemolysis, a workup was initiated to identify a source...the patient continued to require significant transfusion and over the next several days was found to have an ABO incompatibility...The patient...continued to worsen with a [DIAGNOSES REDACTED] process that led to significant [DIAGNOSES REDACTED]...developed worsening renal function requiring continuous renal replacement therapy...also requiring full ventilation which was not improving...Approximately 2 weeks into the patient's hospital stay, once the ABO incompatibility had been corrected, the patient did respond to blood products...the patient over the next week appears to have developed fungemia [The presence of fungi or yeast in the blood, seen in immunosupressed or immunocompromised patients seen with risk factors of broad spectrum antibiotics, dialysis, CVC, high severity illnesses, multiple abdominal surgeries and steroid use.] as well as a fungal UTI [Urinary Tract Infection] which lead to sespis syndrome...On the date of death , the family elected to make the patent comfort care with a DO NOT RESUSCITATE order...at 1224 [12:24 PM] hours on January 3, 2016 the patient expired..."

2. An interview was conducted on 2/8/16 at 10:00 AM in the conference room regarding the wrong blood transfusions for Patient #1. The Risk Manager, Chief Nursing Officer, Director of Quality, Chief Operating Officer, Laboratory Medical Director and the Administrative Director of Lab Services were present during the interview.
The Risk Manager stated there were 2 separate mislabeling episodes that occurred with Patients #1, #2 and #3.
The first one occurred when Patients #1 and #3 were in shock Trauma Room #1 at the same time. A blood sample specimen for Patient #1 and Patient #3 were mislabeled. Patient #1 and Patient #3 had blood samples drawn and both blood samples were labeled with 2 labels. Each blood sample had both names of Patient #1 and Patient #3. The laboratory declined the mislabeled blood samples and called to have the samples re-drawn.

The Risk Manager stated in the meantime the second mislabeling occurrence happened when Patient #1 went for a CT scan and Patient #2 was placed in the Shock Trauma bed that Patient #1 had previously been in. A resident physician, supervised by MD #1, obtained a blood sample per femerol arterial stick from Patient #2. The blood sample was left unlabeled on a table in the patients' room. ER Technician (Tech) #1 returned to the Shock Trauma Room and took Patient #2's unlabeled blood, labeled it with Patient #1's sticker and took the sample to the lab. The blood sample from Patient #2 was identified, labeled and processed as Patient #1's blood sample.

3. Review of the facility's wrong blood administration investigation revealed the following problems identified:
Staff failed to follow the policy for blood specimen labeling and blood hand off process.
Medical staff failed to follow procedure for the hand-off of blood specimen collection. There was only 1 ER technician available for 3 Shock Trauma patients.
Roles, Responsibilities and Positioning of individuals in the room during trauma cases should be defined. There were multiple trauma patients to be stabilized in a short period of time.

Review of the facility's QAPI action plans/interventions to address the identified problems were as follows:

To address the front end registration process and chain of custody for specimens. The "...Front end process to be implemented within 60 days. Chain of custody process by [DATE]."

To address staff contingency plan, training, establish improved visual controls, establish responsibility matrix for Shock Trauma Room.
Some "visual controls" were implemented on 12/21/15. A staff meeting was held on 1/14/16, with implementation initiated on 1/14/16. The "Responsibility matrix presented to the Trauma Committee 2/18/16" and implementation on 3/1/16.

To address multiple trauma arriving in a short timeframe was to establish one-piece flow processes and identify resources to call for surge or max capacity process or policy. This was to be implemented in "60 days."

To perform employee coaching of blood collection policy and 2 staff signatures verifying all blood specimens. This action was implemented on 12/21/15 with remaining staff on 1/14/16.

To address the chain of custody of blood specimen and responsibility matrix a chain of custody plan was to be implemented by the week of 1/22/16. The responsibility matrix was to be (MDS) dated [DATE] and implemented on 3/1/16.

The plan identified the ER Director and Manager were responsible for implementation of the action plan/interventions. The plan documented to conduct audits, direct observations, roundings and post-trauma debriefings to determine if the plan was being implemented. The date to measure and identify the effectiveness was "To be determined."

An interview was conducted on 2/23/16 at 12:30 PM to discuss the corrective action plan/interventions with the ER Director, Risk Manager, Director of Quality, Chief Nursing Officer and ER Manager all present.
The Risk Manager stated the visual controls were implemented on 12/21/15 with the 2 beds in the Shock Trauma Rooms #1 and #2 being labeled as Bed #1 and Bed #2 signs placed above the stretchers and labeled bins affixed to the wall. The Risk Manager stated she became aware of the ABO incompatibility situation on 12/17/15.

The ER Director stated regarding the "surge or max [maximum] capacity process... it's been discussed but not formalized yet."

The surveyor asked if the facility had evidence they had performed any audits, direct observations, roundings or post-trauma debriefings in accordance with the corrective action plan. The ER Nurse Manager stated, "No."

The surveyor asked for evidence that all the physician's had received inservices/training on the corrective action plans/interventions. The facility was unable to provide documentation that all ER physicians had been in-serviced on the corrective action plans/interventions.

There was no documentation the facility's corrective action plans/interventions were implemented, and monitored to ensure they were effective in order to prevent blood samples being drawn from the wrong patients, and blood samples being labeled wrong in order to prevent blood transfusion reactions.

There was no documentation the QAPI committee had identified issues with nursing not documenting, and reporting the laboratory findings of hemolysis due to a blood transfusion error.