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Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Governing Body. The governing body of the facility failed to ensure that nursing care provided to patients by contracted nursing personnel were provided in a safe and effective manner, in compliance with facility policies/procedures and met all standards of the Condition of Participation of Nursing Services. In addition, the governing body of the facility failed to ensure that the facility's performance improvement mechanism/activities adequately investigated an adverse patient event in which there was evidence the contract nurse failed comply with facility policies/procedures. The governing body of the facility failed to ensure that the performance improvement activities related to the adverse patient event met all standards of the Condition of Participation of Quality Assurance/Performance Improvement.

The facility failed to meet the following standards under the condition of Governing Body:

A 0083 Contracted Services Comply With Applicable Conditions of Participation
The governing body of the facility failed to ensure that contracted nursing services provided to Sample Patient #1 by Sample Nurse #1 complied with all standards under the Condition of Participation of Nursing Services. In addition, the governing body failed to ensure that contracted nursing services provided by the corporate hospital system's "regional float pool" complied with all standards under the Condition of Participation of Nursing Services.

Reference Tag A 0385 for the Condition of Participation of Nursing Services.

A 0084 Contracted Services Provided In A Safe And Effective
Manner
The governing body of the facility failed to ensure that contracted nursing services provided to Sample Patient #1 by Sample Patient #1 was provided in a safe an effective manner. The facility failed to ensure that the nurse (Sample Nurse #1) administering blood to a patient (Sample Patient #1) in the Intensive Care Unit (ICU)recognized the signs and symptoms of a potential blood transfusion reaction and took the appropriate actions as outlined in the blood administration policy/procedure. Specifically, the nurse failed to immediately stop the transfusion and contact the critical care physician available in the unit, as required in the policy/procedure, when the patient exhibited signs of a potential transfusion reaction.

Based on review of medical records, personnel files, facility documents and staff/physician interviews, the governing body failed to ensure that nursing care provided by contracted services (including one for shared services) furnished services that permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services. Specifically, the facility failed to ensure that nursing care provided under contracted services by the corporate hospital system's regional float pool complied with the Condition of Participation for Nursing Services.

The facility failed to maintain personnel files including facility specific job descriptions and evidence of orientation, competencies, in-house evaluations and unit-specific life safety competency inventories (which included locating emergency equipment on each unit and knowledge of response procedures) for all nursing staff contracted from the facility's corporate system "regional float pool," in accordance with the tasks and services they were expected to provide.

In addition, the facility failed to ensure that a contracted nurse (Sample Nurse #1) from the "regional float pool" appropriately responded to symptoms of a potential blood transfusion reaction for Sample Patient #1. The nurse failed to follow the hospital policy/procedure for blood administration that required the nurse to immediately stop the blood and contact the physician when symptoms appeared.

These failures created the potential for a negative patient outcomes throughout the facility.

The findings were:

Reference findings in A 0385 Condition of Participation for Nursing Services.

Personnel File Reviews:

On 1/28/10, the personnel files of Sample Nurse #1 were requested for review and revealed the following findings:
The facility provided a file for Sample Nurse #1 beginning 9/2009 for the "Regional Float Pool." Per information provided by the director of quality improvement, the file was a selection of records from the "Regional Float Pool" personnel file for Sample Nurse #1 that were sent to the facility by "fax" (facsimile transmission) on 1/27/2010. The facility compiled the records to create a personnel file, in response to the surveyor request to review the facility's personnel file on Sample Nurse #1. The file contained evidence of orientation to the corporate hospital system policies and procedures, but there was no evidence of orientation specific to the facility or the intensive care unit (ICU) of the facility. The file also contained no evidence of shift evaluations/unit orientations done by the facility.

The file also contained documentation from the on-line education system that the nurse had completed the modules on blood administration titled "Blood Products Safety I: Foundations(PA)" and "Blood Products Safety II: Administration (PA)" on 9/9/09, but the document assigned no time to the modules and under completion, it stated the date and "administrator entered." It was unclear whether the nurse actually completed the module or the administrator of the pool entered it by over-riding the system. There was no evidence the nurse was trained to administer blood and blood by-products and evaluated for competency. The record contained a total of 10 modules that were dated 9/9/09 and entered as "administrator entered," with no time assigned to them. The other modules were titled: "Advanced Directives," "Obstructive Sleep Apnea: Screening and Care-RN's," "Developmentally Appropriate Care of the Pediatric Patient (PA)," "Emergency Preparedness (PA)," "Medication Safety I (PA)," "Medication Safety II (PA)," and "Patient Rights (PA)." There was no evidence of competency evaluations following these on-line modules conducted by the hospital.

The file contained no documentation of the nurse's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs and symptoms to the available critical care physician immediately, in accordance with the facility blood administration policy/procedure.

During the course of the survey, the evaluations for the shifts that Sample Nurse #1 worked through the "regional float pool" were requested from the director of quality improvement. One of the evaluations requested was for the shift in the ICU in which the nurse's patient (Sample Patient #1) had signs/symptoms of a blood transfusion reaction. Near the end of the second day of the survey, the director of quality improvement stated that there were no documents that evaluated or documented the performance of the nurse at the facility when s/he was functioning as a part of the "regional float pool."

Staff Interviews:

An interview with the nursing services team leader/staffing office on 1/27/10 at approximately 2 p.m. revealed that facility did not maintain a file for staff in the corporate hospital system "regional float pool." S/he stated that they did maintain files for private agency nursing staff (per diem and travelers), but not for the "regional float pool." S/he stated that the file that was provided for review was a copy of the file that was maintained by the "regional float pool." It had been copied by the "regional float pool" and provided to the hospital for the survey. S/he stated that shift evaluations were done on "regional float pool" nurses, but the evaluations were sent over to the "regional float pool." S/he stated that the facility did not retain a copy of the evaluations.

During the tour of the ICU on 1/28/10 at approximately 9:45 a.m., the charge nurse on the "step-down unit," (Sample Nurse #2) was shown a copy of the shift evaluation forms and asked which forms s/he complete for the "regional float pool" nurses when they worked on the unit. S/he stated that s/he did not do a shift evaluation for the "regional float pool" nurses because that was not required for that staff category.

During the course of the survey, the evaluations for the shifts that Sample Nurse #1 worked through the "regional float pool" were requested from the director of quality improvement. One of the evaluations requested was for the shift in the ICU in which the nurse's patient (Sample Patient #1) had signs/symptoms of a blood transfusion reaction. Near the end of the second day of the survey, the director of quality improvement stated that there were no documents that evaluated or documented the performance of the nurse at the facility when s/he was functioning as a part of the "regional float pool."

On 1/28/10 at approximately 1:10 p.m., the chief nursing officer for the facility (who also serves as the executive chief nursing officer for the corporate hospital system) and the nursing services director of professional resources (the in-house management coordinator for nursing with "regional float pool") were interviewed about the current practice for in-house personnel files/employee evaluations for the "regional float pool" in general and specifically about communication with the "regional float pool" regarding Sample Nurse #1. The interview provided the following information, in pertinent parts:
---the nursing services director of professional resources stated that s/he had initiated communication with the "regional float pool" regarding Sample Nurse #1's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs/symptoms to the available critical care physician immediately. S/he stated that the "regional float pool" had not been contacted until that day (1/28/10). When asked for a copy of the written documentation of the contact, s/he stated it would be available the next day.
NOTE: On 2/1/10 the surveyors received a copy of the notification to the "regional float pool." The "sent" time on the document was 1/28/10 at approximately 6:55 p.m., 4 hours after the on-site exit for the survey.
---the nursing services director of professional resources reiterated that the employee files for the "regional float pool" were not maintained by the facility, but by the "regional float pool." S/he stated that shift evaluations were not done or maintained in-house by the facility.
---the the chief nursing officer for the facility (who also serves as the executive chief nursing officer for the corporate hospital system) stated that routine in-house evaluations were not currently being done, nor were personnel files being maintained by the facility for the "regional float pool" nurses. When told that the current system was out of compliance with CMS requirements and state licensure requirements, s/he stated that both areas would be corrected immediately at the facility and at the other corporate hospital system facilities, under the authority of his/her role as the executive chief nursing officer for the system.

Medical Record Review:

Review on 1/27/10, of the medical record of Sample Patient #1 revealed the following;
The patient was an elderly adult patient with a history of gastric cancer admitted to the Intensive Care Unit (ICU) on 11/9/09 at 12:33 p.m. for treatment of a Gastrointestinal Bleed. During the hospitalization, the patient was administered multiple units of blood.
On 11/10/09 3:11 a.m., the patient was administered a new unit of blood.
On 11/10/09 at 4 a.m., the nurse (Sample Nurse #1) documented "Blood Pressures of 103/43 and 87/34," "coffee ground emesis with bright red blood" and "oliguria, urine cloudy, dark red." There was no evidence that the blood transfusion was stopped or that the critical care physician, who was on duty for the unit, was notified. The transfusion ended at 5:30 a.m.
On 11/10/09 at 5:50 a.m. the nurse noted "MD notified," almost two hours after the nurse noted the change in condition, but there was no additional documentation regarding the issues addressed in the call. In addition, the nurse documented a blood pressure of 80/30 and "urine: 10 ml dark heme/tea colored urine."
A note from the on-duty critical care physician on 11/10/09 at 8:10 a.m. stated the following: "Events of this a.m. noted. Dark urine and hemolysis on smear....Likely transfusion reaction."
On 11/10/09 at 9:17 a.m., the patient expired.

Physician Interview:

On 1/27/10 at 4:00 p.m. an interview was conducted with Critical Care Intensivist on duty the night of 11/09/09 to 11/10/09). The interview revealed the following findings:
The physician verified that s/he was on duty the night of 11/09 to morning of 11/10/09, but was not able to recall specific times of events regarding Sample Patient #1. S/he was able to recall being notified of decreased urine output and thought that because of the patient's condition, renal decline and a decreased urine output would have been expected. S/he recalled being at the bedside to place a central line to administer fluids at "probably around 6:00 a.m."
When asked, if s/he had been called and was given the following information: new signs/symptoms of coffee ground emesis with bright red blood, oliguria, urine cloudy, dark red and blood transfusion started and infusing, would s/he have assessed the patient at the bedside, s/he stated, "Yes, I would have." When asked if s/he had received such a call regarding Sample Patient #1, s/he stated, "No. I was in the room to place a central line and that was around 6:00 a.m. I was not contacted regarding any other concerns prior to the call to notify me about the decreased urine output."

Policy/Procedure Review:

On 1/27/10, the policy/procedure "Blood and Blood Products," dated and approved 12/13/2005 was reviewed and revealed the following, in pertinent parts:
"...V. Transfusion Reactions:...
Acute Hemolytic Reaction:
An acute reaction may occur during the infusion or within minutes to hours after the blood product has been infused. However, symptoms usually occur after a small amount of blood has been transfused and almost always before the unit is complete...

Beginning Manifestations:
Hypotension and/or tachycardia, fever and/or chills, nausea/vomiting, pain, may include dyspnea, chest tightness, abnormal bleeding, unstable BP, acute renal failure, or shock. In anesthetized patients: a first sign may be hypotension and evidence of disseminated intravascular coagulation.

Hallmark of intravascular hemolysis is hemoglobinuria.

Treatment:
Immediately discontinue transfusion...
Notify the physician and blood bank and complete transfusion reaction form..."

Based on review of medical records, personnel files, facility documents and staff/physician interviews the governing body failed to ensure that nursing care provided by contracted services (including one for shared services) furnished services that permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services. Specifically, the facility failed to ensure that nursing care provided under contracted services by the corporate hospital system's regional float pool were provided in a safe and effective manner.

These failures created the potential for a negative patient outcomes throughout the facility.

The findings were:

Reference findings in Tags A 0083, A 0288, A 0398 and A 0409.

Tag A 0083 provides evidence that the facility failed to ensure that nursing care provided under contracted services by the corporate hospital system's regional float pool complied with The Condition of Participation of Nursing Services.

The facility failed to maintain personnel files including facility specific job descriptions and evidence of orientation, competencies, in-house evaluations and unit-specific life safety competency inventories (which included locating emergency equipment on each unit and knowledge of response procedures) for all nursing staff contracted from the facility's parent system "regional float pool," in accordance with the tasks and services they were expected to provide.

In addition, the facility failed to ensure that a contracted nurse (Sample Nurse #1) from the "regional float pool" appropriately responded to symptoms of a potential blood transfusion reaction for Sample Patient #1. The nurse failed to follow the hospital policy/procedure for blood administration that required the nurse to immediately stop the blood and contact the physician when symptoms appeared.

Tag A 0288 provides evidence that the facility failed to ensure that the performance improvement activities tracked all medical errors and adverse patient events, analyzed their causes and implemented preventive actions and mechanisms that include feedback and learning throughout the hospital.

Specifically, the facility failed to adequately investigate and address the underlying factor that contributed to an event in which Sample Nurse #1 failed to identify and respond appropriately when Sample Patient #1 exhibited symptoms of a potential transfusion reaction. Sample Nurse #1, an Intensive Care Unit (ICU) nurse contracted from the facility's corporate system "regional float pool," failed to respond appropriately to his/her patient's symptoms by stopping the transfusion and notifying the on-site critical care physician immediately, as outlined in the blood administration policy.

Since the facility later determined that Sample Patient #1, who expired the day after the event, did not have a transfusion reaction, the facility failed to investigate the nurse's failure to responded appropriately. Once the facility determined that the patient's symptoms and subsequent death were not due to a blood transfusion reaction, the facility's quality assurance committee did not address Sample Nurse #1's failure to respond appropriately to symptoms of a potential transfusion reaction.

Since no follow-up actions regarding the nurse's clinical lapse were identified in the quality assurance committee, the facility did not notified the "regional float pool" timely that Sample Nurse #1 had failed to identify symptoms of a potential blood transfusion reaction in his/her patient (Sample Patient #1).

The facility did not notify the "regional float pool" until the evening of the last on-site day of the survey (1/28/10), which was more than 2 months after the event. Surveyors determined that Sample Nurse #1 had continued to work as an ICU nurse throughout the corporate hospital system, without restriction, after the 11/10/09 event.

The failures to adequately investigate and address the underlying factors that contributed to the nurse's lapses in clinical performance and the delay in notifying the "regional float pool" placed the patients assigned to Sample Nurse #1 throughout the corporate hospital system at risk during that period.

Tag A 0398 provides evidence the facility failed to ensure that non-employee licensed nurses, who were working in the hospital, adhered to the policies and procedures of the hospital. The facility failed to ensure that the director of nursing services provided adequate supervision and evaluation of the clinical activities of the non-employee nursing personnel which occurred within the responsibility of the nursing services.

Specifically, the facility failed to ensure that the nursing department maintained personnel files, including facility specific job descriptions and evidence of orientation, competencies, in-house evaluations and unit-specific life safety competency inventories (which included locating emergency equipment on each unit and knowledge of response procedures) for all nursing staff contracted from the facility's corporate system "regional float pool."

In addition, the facility failed to ensure that a contracted nurse (Sample Nurse #1), an employee of the corporate hospital system's "regional float pool" complied with with all facility policies and procedures, including those related to blood administration. The facility failed to respond immediately to re-evaluate the competency of the contract nurse (Sample Nurse #1), after s/he failed to comply with the blood administration policy on 11/10/09.

These failures created the potential for a negative patient outcomes throughout the facility, and in the case of Sample Nurse #1, throughout the corporate hospital system via the "regional float pool."

Tag A 0409 provides evidence the facility failed to ensure that blood transfusions, that were being administered by personnel other than doctors of medicine or osteopathy had special training for that duty.

The facility failed to ensure that the nurse (Sample Nurse #1)administering blood to a patient (Sample Patient #1) in the ICU recognized the signs and symptoms of a potential blood transfusion reaction and took the appropriate actions as outlined in the blood administration policy/procedure. Specifically, the nurse failed to immediately stop the transfusion and contact the physician, as required in the policy/procedure, when the patient exhibited evidence of a potential transfusion reaction.

In summary, the facility failed to maintain personnel files for all nursing staff contracted from the facility's corporate system "regional float pool." In addition, the facility failed to ensure that a contracted nurse (Sample Nurse #1) from the "regional float pool" provided care in a safe and effective manner to Sample Patient #1, when s/he presented with symptoms of an acute hemolytic transfusion reaction.

Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Quality Assurance/Performance Improvement (QAPI). The facility failed to ensure that the facility's performance improvement mechanism/activities adequately investigated an adverse patient event in which there was evidence a contract nurse failed to comply with facility policies/procedures.

The facility failed to meet the following standards under the condition of Quality Assurance/Performance Improvement:

A 0288 QAPI Feedback and Learning
The facility failed to ensure that the performance improvement activities tracked all medical errors and adverse patient events, analyzed their causes and implemented preventive actions and mechanisms that include feedback and learning throughout the hospital.

Specifically, the facility failed to adequately investigate and address the underlying factor that contributed to an event in which Sample Nurse #1 failed to identify and respond appropriately when Sample Patient #1 exhibited symptoms of a potential transfusion reaction. Sample Nurse #1, an Intensive Care Unit (ICU) nurse contracted from the facility's corporate hospital system "regional float pool," failed to respond appropriately to his/her patient's symptoms by stopping the transfusion and notifying the on-site critical care physician immediately, as outlined in the blood administration policy.

The failures to adequately investigate and address the underlying factors that contributed to the nurse's lapses in clinical performance and the delay in notifying the "regional float pool" placed the patients assigned to Sample Nurse #1 throughout the corporate hospital system at risk.

These failures created the potential for a negative patient outcomes at the facility and in other facilities within the corporate hospital system.

Based on medical record review, staff/physician interviews, personnel file and facility document reviews, the facility failed to ensure that the performance improvement activities tracked all medical errors and adverse patient events, analyzed their causes and implemented preventive actions and mechanisms that include feedback and learning throughout the hospital.

Specifically, the facility failed to adequately investigate and address the underlying factor that contributed to an event in which Sample Nurse #1 failed to identify and respond appropriately when Sample Patient #1 exhibited symptoms of a potential transfusion reaction. Sample Nurse #1, an Intensive Care Unit (ICU) nurse contracted from the facility's corporate hospital system "regional float pool," failed to respond appropriately to his/her patient's symptoms by stopping the transfusion and notifying the on-site critical care physician immediately, as outlined in the blood administration policy.

Because the facility later determined that Sample Patient #1, who expired the day after the event, did not have a transfusion reaction, the facility failed to investigate the nurse's failure to respond appropriately. Once the facility determined that the patient's symptoms and subsequent death were not due to a blood transfusion reaction, the facility's quality assurance committee did not address Sample Nurse #1's failure to respond appropriately to symptoms of a potential transfusion reaction.

The facility failed to identify/direct any follow-up investigation/actions regarding the nurse's clinical lapse in the quality assurance committee. Once the committee determined that the patient (Sample Patient #1) did not have a transfusion reaction and the nurse (Sample Nurse #1) knew the elements of the policy/procedure for blood administration, the investigation was considered complete. The investigation failed in the following areas:
---No further investigation was done to determine that factors involved in the nurse's failure to exercise appropriate clinical judgement, utilize available resources and follow the blood administration policy, despite being knowledgeable about the elements of the policy.
---No referral was made to the nursing department to identify that a contract nurse operating under that department had failed to exercise appropriate clinical judgement, utilize available resources and follow the blood administration policy.
---No action was taken to ensure that any contributing factors were addressed at an individual/system level to prevent future events.
---No action was taken to alert the "regional float pool" that one of their contract employees had failed to exercise appropriate clinical judgement, utilize available resources and follow the blood administration policy, despite being knowledgeable about the elements of the policy.

The failures to adequately investigate and address the underlying factors that contributed to the nurse's lapses in clinical performance and the delay in notifying the "regional float pool" placed the patients assigned to Sample Nurse #1 throughout the corporate hospital system at risk.

These failures created the potential for a negative patient outcomes at the facility and in other facilities within the corporate hospital system.

The findings were:

1. Medical Record Review:

Review on 1/27/10, of the medical record of Sample Patient #1 revealed the following;
The patient was an elderly adult patient with a history of gastric cancer admitted to the Intensive Care Unit (ICU) on 11/9/09 at 12:33 p.m. for treatment of a Gastrointestinal Bleed. During the hospitalization, the patient was administered multiple units of blood.
On 11/10/09 3:11 a.m., the patient was administered a new unit of blood.
On 11/10/09 at 4 a.m., the nurse (Sample Nurse #1) documented "Blood Pressures of 103/43 and 87/34," "coffee ground emesis with bright red blood" and "oliguria, urine cloudy, dark red." There was no evidence that the blood transfusion was stopped or that the critical care physician, who was on duty for the unit, was called. The transfusion ended at 5:30 a.m.
On 11/10/09 at 5:50 a.m. the nurse noted "MD notified," but no additional documentation regarding the issues addressed in the call. In addition, the nurse documented a blood pressure of 80/30 and "urine: 10 ml dark heme/tea colored urine."
A note from the on-duty critical care physician on 11/10/09 at 8:10 a.m. stated the following: "Events of this a.m. noted. Dark urine and hemolysis on smear....Likely transfusion reaction."
on 11/10/09 at 9:17 a.m., the patient expired.

Review of Investigation Report Regarding Sample Patient #1 by Blood Bank Medical Director:

Review on 1/28/10 of the pathology report (electronically signed on 11/18/09) from the blood bank medical director, in which samples collected to determine if a transfusion reaction had occurred, were reviewed and revealed the following findings, in pertinent parts:
"...During transfusion of (rbc) red blood cells patient developed hemoglobinuria and hemoglobinemia. Patient expired within 8 hours from massive hemolysis which resulted in low Hct(hematocrit), renal failure and DIC (disseminated intravascular coagulation)....Gram stain and cultures of the bags (blood) were negative. Bags/tubing inspected for discoloration or signs of hemolysis - all negative...Patient blood culture positive for Fusobacterium. Patient was not on antibiotics...No evidence of hemolytic transfusion reaction. Fusobacterium sepsis."

2. Staff Interviews:

On 1/27/10 at approximately 10:10 a.m., the patient safety manager, a registered nurse, was interviewed about her investigation of the possible transfusion reaction for Sample Patient #1. The interview revealed the following findings:
The patient safety manager stated that she interviewed the nurse (Sample Nurse #1) about the sequence of events that occurred as s/he was caring for Sample Patient #1 during the early morning hours of 11/10/09. She stated that the nurse knew the contents of the blood administration policy ("Blood and Blood Products," dated and approved 12/13/2005). S/he stated that the nurse explained that s/he did not stop the blood because it had already "run through." Sample Nurse #1 also apparently explained to the patient safety manager that s/he "thought the hemolysis was DIC, not a transfusion reaction." The patient safety manager stated that the nurse was unable to account for the discrepancy with his/her statement that the blood had already "run through," when that time frame "did not 'jive' with the medical record."
NOTE: the medical record indicated that the transfusion was not completed until 5:30 a.m. which was 1.5 hours after the signs/symptoms of a probable transfusion reaction presented at 4 a.m.
The patient safety manager stated that the case was presented at the Patient Safety Council on 12/2/09. S/he stated that no follow-up action was required, since it was determined that the nurse knew the policy, had completed the blood administration training module (in 9/09) and the hemolysis was determined not to be due to a transfusion reaction after all. When asked in subsequent interviews during the survey why the issue of the nurse's not following the policy (not stopping blood/immediately contacting the physician) was not addressed, the patient safety manager stated once it was determined that it was not a transfusion reaction and the nurse knew the policy it was dropped. S/he acknowledged that they may have "dropped the ball" by not considering the need for further action related to the nurse's failure to follow the policy (by immediately stopping the blood/contacting the physician).

The director of quality improvement participated in part of the interview with the patient safety manager on 1/27/10 at approximately 10:30 a.m. S/he confirmed that the patient safety manager, did the initial investigation and then the case was brought to the Patient Safety Council on 12/2/09. S/he also stated the council members had concerns about the fact that the nurse's (Sample Nurse #1) explanation about his/her failure to stop the blood immediately and call the physician did not line up with the facts in the medical records. S/he stated that once the determination was made that the nurse knew the policy and that the event was not a transfusion reaction, the investigation was completed with no action items. S/he acknowledged that the committee may have "dropped the ball in this case," in not looking further at the nurse's actions that were outside of the policy. S/he stated that in the committee when a human resource issue is identified, the committee takes the issue no further. In subsequent interviews, s/he stated that the patient safety manager had a tracking system for insuring that human resource issues get properly referred under their "just culture," program. S/he explained that the "just culture" program was intended to address clinical errors/issues in way that allowed for staff members and the system to learn from investigation of clinical errors/issues by avoiding a blaming/punitive environment.
The concerns related to Sample Nurse #1 were not referred for any action after the 11/10/09 events regarding Sample Patient #1, so the "just culture" program was not utilized.

During the course of the survey, the evaluations for the shifts that Sample Nurse #1 worked through the "regional float pool" were requested from the director of quality improvement. One of the evaluations requested was for the shift in the ICU in which the nurse's patient (Sample Patient #1) had signs/symptoms of a blood transfusion reaction. Near the end of the second day of the survey, the director of quality improvement stated that there were no documents that evaluated or documented the performance of the nurse at the facility when s/he was functioning as a part of the "regional float pool."

On 1/28/10 at approximately 1:10 p.m., the nursing services director of professional resources (the in-house management coordinator for nursing with "regional float pool" was interviewed about communication with the "regional float pool" regarding Sample Nurse #1. The interview provided the following information, in pertinent parts:
The nursing services director of professional resources stated that s/he had initiated communication with the "regional float pool" regarding Sample Nurse #1's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs/symptoms to the available critical care physician immediately. S/he stated that the "regional float pool" had not been contacted until that day (1/28/10). When asked for a copy of the written documentation of the contact, s/he stated it would be available the next day.
NOTE: On 2/1/10 the surveyors received a copy of the notification to the "regional float pool." The "sent" time on the document was 1/28/10 at approximately 6:55 p.m., 4 hours after the on-site exit for the survey.

3. Review of Patient Safety Council Minutes:

Review of the 12/2/09 meeting minutes for the Patient Safety Council revealed the following findings, in pertinent parts:
Regarding Sample Patient #1:
"...State report-concern with blood transfusion reaction but secondary to Fusobacterium sepsis (Haven't gotten sign off from state. Depending on response ask NPC (Nurse Practice Council) if there's feedback on whether further education needed on signs of mass hemolysis..."
NOTE: Per multiple interviews with the patient safety manager and the director of quality improvement, "there were no action items from the Patient Safety Council," regarding the Sample Patient #1 case review.

4. Personnel File:

On 1/28/10, the personnel files of Sample Nurse #1 were requested for review and revealed the following findings:
The facility provided a file for Sample Nurse #1 beginning 9/2009. The file contained no documentation of the nurse's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs and symptoms to the available critical care physician immediately.

In summary, the facility failed to utilize performance improvement activities to evaluate the care of Sample Patient #1 by Sample Nurse #1 on 11/10/09. The performance improvement activities were driven/limited by the determination that the patient's acute hemolytic reaction was secondary to a sepsis, rather than a transfusion reaction. The performance improvement investigation failed to seriously address the important fact that at the time care was provided, the cause of the acute hemolysis was not known. The critical care physician who finally was called to assess the patient for decrease urine output noted that the symptoms of acute hemolysis were "likely a transfusion reaction." Even if the nurse, as s/he stated to the patient safety manager, "thought the hemolysis was DIC, not a transfusion reaction," the physician should have been notified to confirm his/her "diagnosis" and potentially institute other treatment. The nurse failed to follow the facility policy regarding the suspected transfusion reaction, or to at least notify the doctor about the symptoms of acute hemolytic reaction or DIC. The performance improvement investigative activities failed to address the nurse's failure to follow appropriate policies/procedures, utilize available physician/nursing staff resources and operate within his/her scope of nursing practice.

Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Nursing Services. The facility failed to appropriately orient and supervise contracted nursing staff and ensure appropriate training and competency evaluation of contracted staff.

The facility failed to meet the following standards under the condition of Nursing Services:

A 0398 Supervision on Contract Staff
The facility failed to ensure the nursing department maintained personnel files, including facility specific job descriptions and evidence of orientation, competencies, in-house evaluations and unit-specific life safety competency inventories (which included locating emergency equipment on each unit and knowledge of response procedures) for all nursing staff contracted from the facility's corporate system "regional float pool." The failure created the potential for a negative patient outcome.

A 0409 Blood Transfusions and IV Medications
The facility failed to ensure that the nurse (Sample Nurse #1)administering blood to a patient (Sample Patient #1) in the ICU recognized the signs and symptoms of a potential blood transfusion reaction and took the appropriate actions as outlined in the blood administration policy/procedure. Specifically, the nurse failed to immediately stop the transfusion and contact the critical care physician available in the unit, as required in the policy/procedure, when the patient exhibited signs of a potential transfusion reaction.

Based on review of personnel files, staff interviews and facility documents, the facility failed to ensure that non-employee licensed nurses, who were working in the hospital, adhered to the policies and procedures of the hospital. The facility failed to ensure that the director of nursing services provided adequate supervision and evaluation of the clinical activities of the non-employee nursing personnel which occurred within the responsibility of the nursing services.

Specifically, the facility failed to ensure that the nursing department maintained personnel files, including facility specific job descriptions and evidence of orientation, competencies, in-house evaluations and unit-specific life safety competency inventories (which included locating emergency equipment on each unit and knowledge of response procedures) for all nursing staff contracted from the facility's corporate system "regional float pool."

In addition, the facility failed to ensure that a contracted nurse (Sample Nurse #1), an employee of the corporate hospital system's "regional float pool" complied with all facility policies and procedures, including those related to blood administration. The facility failed to respond immediately to re-evaluate the competency of the contract nurse (Sample Nurse #1), after s/he failed to comply with the blood administration policy on 11/10/09.

These failures created the potential for a negative patient outcomes throughout the facility, and in the case of Sample Nurse #1, throughout the corporate hospital system via the "regional float pool."

The findings were:

Personnel File:

On 1/28/10, the personnel files of Sample Nurse #1 were requested for review and revealed the following findings:
The facility provided a file for Sample Nurse #1 beginning 9/2009 for the "Regional Float Pool." The file contained evidence of orientation to the corporate hospital system policies and procedures, but there was no evidence of orientation specific to the facility or the ICU of the facility. The file also contained no evidence of shift evaluations/unit orientations done by the facility.

The file contained a completed print-out from the on-line education system showing the modules on blood administration titled "Blood Products Safety I: Foundations(PA)" and "Blood Products Safety II: Administration (PA)" on were completed 9/9/09, but the document assigned no time to the modules and under completion, it stated the date and "administrator entered," unlike other entries which showed time (in minutes) to complete the module and nurse sign-off. It was unclear whether the nurse actually completed the module or the administrator of the pool entered it by over-riding the system. The record contained a total of 10 modules that were dated 9/9/09 and entered as "administrator entered," with no time assigned to them. The other modules were titled: "Advanced Directives," "Obstructive Sleep Apnea: Screening and Care-RN's," "Developmentally Appropriate Care of the Pediatric Patient (PA)," "Emergency Preparedness (PA)," "Medication Safety I (PA)," "Medication Safety II (PA)," and "Patient Rights (PA)." There was no evidence of competency evaluations following these on-line modules conducted by the hospital.

The personnel file contained no documentation of the nurse's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs and symptoms to the available critical care physician immediately.

During the course of the survey, the evaluations for the shifts that Sample Nurse #1 worked through the "regional float pool" were requested from the director of quality improvement. One of the evaluations requested was for the shift in the ICU in which the nurse's patient (Sample Patient #1) had signs/symptoms of a blood transfusion reaction. Near the end of the second day of the survey, the director of quality improvement stated that there were no documents that evaluated or documented the performance of the nurse at the facility when s/he was functioning as a part of the "regional float pool."

Staff Interviews:

On 1/27/10 at approximately 10:10 a.m., the patient safety manager, a registered nurse, was interviewed about her investigation of the possible transfusion reaction for Sample Patient #1. The interview revealed the following findings:
The patient safety manager stated that she interviewed the nurse (Sample Nurse #1) about the sequence of events that occurred as s/he was caring for Sample Patient #1 during the early morning hours of 11/10/09. She stated that the nurse knew the contents of the blood administration policy ("Blood and Blood Products," dated and approved 12/13/2005). S/he stated that the nurse explained that s/he did not stop the blood because it had already "run through." Sample Nurse #1 also apparently explained to the patient safety manager that s/he "thought the hemolysis was DIC, not a transfusion reaction." The patient safety manager stated that the nurse was unable to account for the discrepancy with his/her statement that the blood had already "run through," when that time frame "did not 'jive' with the medical record."
NOTE: the medical record indicated that the transfusion was not completed until 5:30 a.m. which was 1.5 hours after the signs/symptoms of a probable transfusion reaction presented at 4 a.m.
The patient safety manager stated that the case was presented at the Patient Safety Council on 12/2/09. S/he stated that no follow-up action was required, since it was determined that the nurse knew the policy, had completed the blood administration training module (in 9/09) and the hemolysis was determined not to be due to a transfusion reaction after all. When asked in subsequent interviews during the survey why the issue of the nurse's not following the policy (not stopping blood/immediately contacting the physician) was not addressed, the patient safety manager stated once it was determined that it was not a transfusion reaction and the nurse knew the policy it was dropped. S/he acknowledged that they "may have dropped the ball," by not considering the need for further action related to the nurse's failure to follow the policy (by immediately stopping the blood/contacting the physician).

The director of quality improvement participated in part of the interview with the patient safety manager on 1/27/10 at approximately 10:30 a.m. S/he confirmed that the patient safety manager, did the initial investigation and then the case was brought to the Patient Safety Council on 12/2/09. S/he also stated the council members had concerns about the fact that the nurse's (Sample Nurse #1) explanation about his/her failure to stop the blood immediately and call the physician did not line up with the facts in the medical records. S/he stated that once the determination was made that the nurse knew the policy and that the event was not a transfusion reaction, the investigation was completed with no action items. S/he acknowledged that the committee may have "dropped the ball in this case," in not looking further at the nurse's actions that were outside of the policy.

An interview with the nursing services team leader/staffing office on 1/27/10 at approximately 2 p.m. revealed that facility does not maintain a file for staff in the corporate hospital system "regional float pool." S/he stated that they do maintain files for private agency nursing staff (per diem and travelers), but not for the "regional float pool." S/he stated that the file that was provided for review was a copy of the file that was maintained by the "regional float pool." It had been copied by the "regional float pool" and provided to the hospital for the survey. S/he stated that shift evaluations are done on "regional float pool" nurses, but the evaluations are sent over to the "regional float pool." S/he stated that the facility does not retain a copy of the evaluations.

During the tour of the ICU on 1/28/10 at approximately 9:45 a.m., the charge nurse on the "step-down unit," the charge nurse (Sample Nurse #2) was shown a copy of the shift evaluation forms and asked which forms s/he complete for the "regional float pool" nurses when they worked on the unit. S/he stated that s/he did not do a shift evaluation for the "regional float pool" nurses because that was not required for that staff category.

On 1/27/10 at approximately 2 p.m., the director of quality improvement provided a copy of an e-mail from the nursing services director of professional resources, in which s/he outlined his/her role in providing oversight/liaison to the "regional float pool." The e-mail stated the following:
"I am notified with any issue that may occur with Regional Float Pool. They daily check in and out of the staffing office. I communicate with them personally at the time if we are aware of a situation and also do follow-up with their manager and education specialist. I am part of the (corporate hospital system) committee that routinely evaluates their orientation and they complete the same educational competencies as all (corporate hospital system) nurses."

On 1/28/10 at approximately 1:10 p.m., the chief nursing officer for the facility (who also serves as the executive chief nursing officer for the corporate hospital system) and the nursing services director of professional resources (the in-house management coordinator for nursing with "regional float pool" were interviewed about the current practice for in-house personnel files/employee evaluations for the "regional float pool" in general and specifically about communication with the "regional float pool" regarding Sample Nurse #1. The interview provided the following information, in pertinent parts:
---the nursing services director of professional resources stated that s/he had initiated communication with the "regional float pool" regarding Sample Nurse #1's failure to identify a possible transfusion reaction and subsequent failure to immediately stop the transfusion and report signs/symptoms to the available critical care physician immediately. S/he stated that the "regional float pool" had not been contacted until that day (1/28/10). When asked for a copy of the written documentation of the contact, s/he stated it would be available the next day.
NOTE: On 2/1/10 the surveyors received a copy of the notification to the "regional float pool." The "sent" time on the document was 1/28/10 at approximately 6:55 p.m., 4 hours after the on-site exit for the survey.
---the nursing services director of professional resources reiterated that the employee files for the "regional float pool" were not maintained by the facility, but by the "regional float pool." S/he stated that shift evaluations were not done or maintained in-house by the facility.
---the chief nursing officer for the facility (who also serves as the executive chief nursing officer for the corporate hospital system) stated that routine in-house evaluations were not currently being done, nor were personnel files being maintained by the facility for the "regional float pool" nurses. When told that the current system was out of compliance with CMS requirements and state licensure requirements, s/he stated that both areas would be corrected immediately at the facility and at the other corporate hospital system facilities, under the authority of his/her role as the executive chief nursing officer for the system.

In summary, the facility failed to ensure that the nursing department maintained personnel files for all nursing staff contracted from the facility's corporate system "regional float pool," and to ensure that contract nursing personnel complied with the policies/procedures of the hospital. When a contract nurse (Sample Nurse #1) failed to comply with the blood administration policy on 11/10/09, the nursing department failed to take any action to investigate or correct the situation until 1/28/10.

Based on medical record review, staff interviews, review of facility meeting minutes, documents and policies and procedures, the facility failed to ensure that blood transfusions, that were being administered by personnel other than doctors of medicine or osteopathy had special training for that duty.

The facility failed to ensure that the nurse (Sample Nurse #1)administering blood to a patient (Sample Patient #1) in the ICU recognized the signs and symptoms of a potential blood transfusion reaction and took the appropriate actions as outlined in the blood administration policy/procedure. Specifically, the nurse failed to immediately stop the transfusion and contact the physician, as required in the policy/procedure, when the patient exhibited signs of a potential transfusion reaction. The failure created the potential for a negative patient outcome.

The findings were:

1. Personnel File for Sample Nurse #1:

On 1/28/10, the personnel files of Sample Nurse #1 were requested for review and revealed the following findings:
The facility provided a file for Sample Nurse #1 beginning 9/2009 for the "Regional Float Pool." The file contained evidence of evaluation to the corporate hospital system policies and procedures, but there was no evidence of orientation specific to the facility or the ICU of the facility. The file also contained no evidence of shift evaluations/unit orientations done by the facility.

The file contained a completed print-out from the on-line education system showing the modules on blood administration titled "Blood Products Safety I: Foundations(PA)" and "Blood Products Safety II: Administration (PA)" were completed 9/9/09, but the document assigned no time to the modules and under completion, it stated the date and "administrator entered," unlike other entries which showed time (in minutes) to complete the module and nurse sign-off. It was unclear whether the nurse actually completed the module or the administrator of the pool entered it by over-riding the system. In summary, there was no evidence the nurse was actually trained to administer blood and blood by-products and evaluated for competency.

2. Policy/Procedure Review:

On 1/27/10, the policy/procedure "Blood and Blood Products," dated and approved 12/13/2005 was reviewed and revealed the following, in pertinent parts:
"...V. Transfusion Reactions:...
Acute Hemolytic Reaction:
An acute reaction may occur during the infusion or within minutes to hours after the blood product has been infused. However, symptoms usually occur after a small amount of blood has been transfused and almost always befor the unit is complete...

Beginning Manifestations:
Hypotension and/or tachycardia, fever and/or chills, nausea/vomiting, pain, may include dyspnea, chest tightness, abnormal bleeding, unstable BP, acute renal failure, or shock. In anesthetized patients: a first sign may be hypotension and evidence of disseminated intravascular coagulation.

Hallmark of intravascular hemolysis is hemoglobinuria.

Treatment:
Immediately discontinue transfusion...
Notify the physician and blood bank and complete transfusion reaction form..."

3. Medical Record Review:

Review on 1/27/10, of the medical record of Sample Patient #1 revealed the following;
The patient was an elderly adult patient with a history of gastric cancer admitted to the Intensive Care Unit (ICU) on 11/9/09 at 12:33 p.m. for treatment of a Gastrointestinal Bleed. During the hospitalization, the patient was administered multiple units of blood.
On 11/10/09 3:11 a.m., the patient was administered a new unit of blood. Prior to this transfusion, the record revealed urine was clear yellow in color.
On 11/10/09 at 4 a.m., the nurse (Sample Nurse #1) documented "Blood Pressures of 103/43 and 87/34," "coffee ground emesis with bright red blood" and "oliguria, urine cloudy, dark red." There was no evidence that the blood transfusion was stopped or that the critical care physician, who was on duty for the unit, was called. The transfusion ended at 5:30 a.m.
On 11/10/09 at 5:50 a.m. the nurse noted "MD notified," but no additional documentation regarding the issues addressed in the call. In addition, the nurse documented a blood pressure of 80/30 and "urine: 10 ml dark heme/tea colored urine."
A note from the on-duty critical care physician on 11/10/09 at 8:10 a.m. stated the following: "Events of this a.m. noted. Dark urine and hemolysis on smear....Likely transfusion reaction."
On 11/10/09 at 9:17 a.m., the patient expired.

4. Physician Interview:

On 1/27/10 at 4:00 p.m. an interview was conducted with Critical Care Intensivist on duty the night of 11/09/09 to 11/10/09. The interview revealed the following findings:
The physician verified that s/he was on duty the night of 11/09 to morning of 11/10/09, but was not able to recall specific times of events regarding Sample Patient #1. S/he was able to recall being notified of decreased urine output and thought that because of the patient's condition, renal decline and a decreased urine output would have been expected. S/he recalled being at the bedside to place a central line to administer fluids at "probably around 6:00 a.m."
When asked, if s/he had been called and was given the following information: new signs/symptoms of coffee ground emesis with bright red blood, oliguria, urine cloudy, dark red and blood transfusion started and infusing, would s/he have assessed the patient at the bedside, s/he stated, "Yes, I would have." When asked if s/he had received such a call regarding Sample Patient #1, s/he stated, "No. I was in the room to place a central line and that was around 6:00 a.m. I was not contacted regarding any other concerns prior to the call to notify me about the decreased urine output."

5. Staff Interviews:

On 1/27/10 at approximately 10:10 a.m., the patient safety manager, a registered nurse, was interviewed about her investigation of the possible transfusion reaction for Sample Patient #1. The interview revealed the following findings:
The patient safety manager stated that she interviewed the nurse (Sample Nurse #1) about the sequence of events that occurred as s/he was caring for Sample Patient #1 during the early morning hours of 11/10/09. She stated that the nurse knew the contents of the blood administration policy ("Blood and Blood Products," dated and approved 12/13/2005). S/he stated that the nurse explained that s/he did not stop the blood because it had already "run through." Sample Nurse #1 also apparently explained to the patient safety manager that s/he "thought the hemolysis was DIC, not a transfusion reaction." The patient safety manager stated that the nurse was unable to account for the discrepancy with his/her statement that the blood had already "run through," when that time frame "did not 'jive' with the medical record."
NOTE: the medical record indicated that the transfusion was not completed until 5:30 a.m. which was 1.5 hours after the signs/symptoms of a probable transfusion reaction presented at 4 p.m.

The director of quality improvement participated in part of the interview with the patient safety manager on 1/27/10 at approximately 10:30 a.m. S/he confirmed that the patient safety manger, did the initial investigation and then the case was brought to the Patient Safety Council on 12/2/09. S/he also stated the council members had concerns about the fact that the nurse's (Sample Nurse #1) explanation about his/her failure to stop the blood immediately and call the physician did not line up with the facts in the medical records.

In summary, the facility failed to evaluate the skills and abilities of Sample Nurse #1 to ensure that s/he was adequately trained and competent to administer blood and blood by-products prior to administering blood to Sample Patient #1 on 11/10/09.