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Based on the nature of the deficiencies cited, the hospital failed to comply with the Condition of Participation of Quality Assurance and Performance Improvement (QAPI). The hospital failed to demonstrate evidence of facility-wide education and training and timely completion of action plans resulting from a quality assessment of an adverse patient event.

The facility failed to meet the following standards under the Condition of Quality Assurance and Performance Improvement:

A0285 QAPI Patient Safety
The hospital must set priorities for its performance improvement activities that -
Focus on high-risk, high-volume, or problem prone areas;

Consider the incidence, prevalence, and severity of problems in those areas; and

Affect health outcomes, patient safety, and quality of care.

A0288 QAPI Feedback and Learning
Performance improvement activities must track medical errors and adverse patient events, analyze their causes and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.


The facility failed to meet one standard under the Condition of Nursing:

A0404 Administration of Drugs
Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under ?482.12(c), and accepted standards of practice.

Based on staff interviews, medical record review and facility documentation review, the hospital failed to set priorities for its performance improvement activities that affect health outcomes, patient safety and quality of care. The hospital failed to complete in a timely manner action plans identified to assist personnel to prevent an adverse medication event. Failure to complete identified action plans in a timely manner created the potential for negative patient harm.


The findings were:

1. On 5/11/2010, a review of sample patient #1's medical record revealed the following: s/he was an 86 year old patient, admitted on 2/27/2010, for small bowel obstruction and who underwent surgery to unblock the obstruction on this date. S/he required continued ventilatory assistance due to respiratory insufficiency and was transferred to the intensive care unit (ICU) where s/he inadvertently received a large bolus of the medication Propofol shortly after arrival. The patient became unresponsive with a severely low blood pressure and required resuscitation fluid and additional medication. The patient remained hospitalized for 24 days and was transferred on 3/23/2010, to a skilled nursing facility with weakness, some memory loss, dysphagia, a urinary catheter, and cecoileostomy drain following a second surgery for Ogilvie Syndrome. Her/his prognosis was good according to the primary physician.

2. An interview with the Director of Quality and Risk Management on 5/11/2010, at approximately 10:15 a.m., revealed the following: a hospital investigation of the occurrence revealed that a ICU nurse had inadvertently given the patient a large amount of Propofol. The ICU utilizes 2 pumps, single and triple pumps. Propofol is pre-programmed into the single pumps, but cannot be pre-programmed into the triple pumps. A nurse must manually enter the data. In this case, a bottle of Propofol was hung on a triple pump and the nurse incorrectly programmed the rate of administration such that the patient was given the entire amount in a short period of time.

Several action activities had been identified by hospital personnel that might help to prevent a similar occurrence in the future. These included:

a. policy and procedure change for the policy, "Medication Administration", involving the inclusion of Propofol as a high risk medication and requiring 2 RN (registered nurse) verification of Propofol dose and order before starting the medication on a patient;

b. policy and procedure change for the policy, "Post-op Recovery in ICU", requiring ICU (intensive care unit) nurses recover patients brought from PACU (post anesthesia care unit) after a hand-off communication has occurred;

c. education of all staff regarding differences in single and triple pumps;

d. development of a task force to review ICU staffing;

e. research of Situational Awareness training for clinical staff to assist during times of distraction;

f. demonstration of new intravenous pumps that include more safety features;

g. ICU representation at the Nurse Practice Council; and

h. prohibition of visitors in the ICU during shift change and hand-off communication.

During the interview the Director made a call to the Pharmacy Director (as owner of the Medication Administration policy) and requested a final draft. S/he brought this to the surveyor approximately 10 minutes later. The Director asked the pharmacist if a blast email regarding the change in policy had been provided to the staff as of this date. The pharmacist stated no, but would do so today. The Medication Administration policy had been approved by the Nurse Practice Council on 5/05/2010; however, neither policy had been approved by the Governing Body of the hospital. A target date to complete this was scheduled for 5/31/2010. The Director stated education of the staff regarding the new policies and pump issues had been completed, although a target date of 5/31/2010, was also noted in the action plan. S/he stated the ICU nurse manager had discussed this with each of the staff nurses.
Further discussion revealed that the hospital had started a task force to review ICU staffing depending on the acuity of the patients. The Director stated staffing was not an issue for this patient, but the facility determined a need to perform this action item by 6/15/2010. The Director also explained that the hospital was researching Situational Awareness training for the staff to assist them to better manage patient care. The target date for completion of this action item was 8/01/2010. Additional action plans included evaluation of other intravenous pumps that provided more safety features to help prevent medication errors in the future. New pumps were scheduled to be on site for demonstration purposes only starting this month. A final decision was targeted for 8/01/2010.

According to the Director, an investigation had been ongoing, but a group meeting with management personnel did not occur until 5/04/2010, and therefore, target dates were still out. Copies of the proposed policy and procedure changes were provided to the surveyor.

3. An interview with the Director of ICU on 5/11/2010, at approximately 10:40 a.m., revealed that s/he had a staff meeting on 3/24/2010, at which time the medication and pump issues were discussed. Even though the policy for Propofol as a high risk medication requiring 2 RN verification had not been finalized, staff had started doing this following the incident. If a staff member was absent from a meeting, the ICU Director would follow up personally with the individual. S/he stated all staff had been appropriately educated regarding the issues, but s/he did not have documentation showing evidence that education had been completed for 100% of staff. S/he provided minutes from a 3/24/2010, staff meeting in which, three nurses were absent.

The surveyor asked the Director about other medications that could not be pre-programmed into the triple pump. S/he did not know as the list of possible medications was quite long. When asked if a sign had been placed on the pumps or poles to alert staff about the issue, s/he stated no. As a result of the interview, the Director stated s/he would research all potential medications that could not be pre-programmed and required manual programming to see if staff needed further education regarding administration of these medications.

The Director stated that both s/he and the Chief Medical Officer had spoken with the nurse after the incident. The nurse was very remorseful and took full responsibility for her/his actions. It was not an educational issue as s/he was aware that the triple pumps did not have pre-programming capability; s/he just programmed the pump incorrectly in the rush of admitting the patient to the ICU. In addition, the Chief Nursing Officer met with the nurse following the incident and a meeting of the Medication Team. No documentation of these meetings was provided to the surveyor.

4. A review of the personnel file for the nurse on 5/11/2010, revealed that s/he had been employed since 9/20/2005 and was a stellar employee based on previous evaluations. S/he had appropriate certifications for life support resuscitation and trauma patients. There was a job description and current licensure on file. There were no counseling reports in the file.

In summary, an 86 year old patient received a large amount of the medication, Propofol, requiring emergent measures to treat. The patient had a prolonged hospitalization and developed additional medical problems. Further care was required at a skilled nursing facility. Although her/his prognosis was considered good, the patient required a longer intubation period and hospitalization than s/he would have if the adverse medication event had not occurred. The facility identified several action items that would assist nurses to prevent a similar adverse event in the future. Although managers and directors stated in interviews that some of the components had been discussed with their staff and were in effect, documentation of completion was lacking. During a survey investigation two months after the event, several action plans were noted to be still pending. Future patient safety and quality of care are at risk until all action plans have been completed and staff are educated.

Based on medical record review, staff interviews, and facility documentation review, the hospital failed to complete in a timely manner preventive actions and mechanisms designed to prevent a reoccurrence of an adverse patient event. Specifically, target dates for completion of activities and actions determined to assist staff to prevent a future similar adverse patient event were scheduled for completion between three and five months after the incident. Failure to implement in a timely manner preventive actions and mechanisms that include feedback and learning throughout the hospital created the potential for negative patient harm.

Cross Reference AO285 QAPI Patient Safety
The hospital must set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems on those areas; and affect health outcomes, patient safety, and quality of care.

The findings were:

1. On 5/11/2010, a review of sample patient #1's medical record revealed the following: s/he was an 86 year old patient admitted on 2/27/2010 for small bowel obstruction and who underwent surgery to unblock the obstruction on this date. S/he required continued ventilatory assistance due to respiratory insufficiency and was transferred to the intensive care unit (ICU) where s/he inadvertently received a large bolus of the medication Propofol shortly after arrival. The patient became unresponsive with a severely low blood pressure and required resuscitation fluid and additional medication. The patient remained hospitalized for 24 days and was transferred to a skilled nursing facility with weakness, some memory loss, dysphagia, a urinary catheter, and cecoileostomy drain following a second surgery for Ogilvie Syndrome. Her/his prognosis was good according to the primary physician.

2. An interview with the Director of Quality and Risk Management on 5/11/2010, at approximately 10:15 a.m., revealed the following: a hospital investigation of the occurrence revealed that a ICU nurse had inadvertently given the patient a large amount of Propofol. The ICU utilizes 2 pumps, single and triple pumps. Propofol is pre-programmed into the single pumps, but cannot be pre-programmed into the triple pumps. A nurse must manually enter the data. In this case, a bottle of Propofol was hung on a triple pump and the nurse incorrectly programmed the rate of administration such that the patient was given the entire amount in a short period of time.

Several action activities had been identified by hospital personnel that might help to prevent a similar occurrence in the future. Completion target dates ranged from 5/31/2010 to 8/01/2010. According to the Director, an investigation had been ongoing, but a group meeting with management personnel did not occur until 5/04/2010, and therefore, target dates were still out. Copies of proposed policy and procedure changes were provided to the surveyor. These would not be approved until the Governing Body reviewed them at the end of this month. The Pharmacy Director had not notified nursing staff regarding the revision of the "Medication Administration" policy until requested to do so by the Director of Quality on the day of the survey. The hospital wanted to conduct research regarding pumps with improved safety features and educational training that had not been completed as of the survey date.

3. An interview with the Director of ICU on 5/11/2010, at approximately 10:40 a.m., revealed that s/he had a staff meeting on 3/24/2010, at which time the medication and pump issues were discussed. Even though the policy for Propofol as a high risk medication requiring 2 RN verification had not been finalized, staff had started doing this following the incident. Three RN's were absent from the staff meeting. If a staff member was absent from a meeting, the ICU Director would follow up personally with the individual. S/he stated all staff had been appropriately educated regarding the issues, but s/he did not have documentation showing evidence that education had been completed for 100% of staff.

The surveyor asked the Director about other medications that could not be pre-programmed into the triple pump. S/he did not know as the list of possible medications was quite long. When asked if a sign had been placed on the pumps or poles to alert staff about the issue, s/he stated no. As a result of the interview, the Director stated s/he would research all potential medications that could not be pre-programmed and required manual programming to see if staff needed further education regarding administration of these medications.

The Director stated that both s/he and the Chief Medical Officer had spoken with the nurse after the incident. The nurse was very remorseful and took full responsibility for her/his actions. It was not an educational issue as s/he was aware that the triple pumps did not have pre-programming capability; s/he just programmed the pump incorrectly in the rush of admitting the patient to the ICU. In addition, the Chief Nursing Officer met with the nurse following the incident and a meeting of the Medication Team. No documentation of these meetings was provided to the surveyor.

In summary, an 86 year old patient received a large amount of the medication, Propofol, requiring emergent measures to treat. The patient had a prolonged hospitalization and developed additional medical problems. Although her/his prognosis was considered good, it is unknown whether the residual medical issues were resolved. The facility identified several action items that would assist nurses to prevent a similar adverse event in the future. Managers and directors stated in interviews that education of all staff had been completed, but documentation of this was not provided. During a survey investigation two months after the event, preventive actions and mechanisms with feedback and learning throughout the hospital were noted to be incomplete.

Based on medical record review, staff interviews, facility documentation review, and review of personnel files, the hospital failed to ensure medications were administered within accepted standards of practice. Specifically, a nurse programmed a triple pump device to deliver a high-risk medication such that sample patient #1 received a critical amount requiring emergent measures to treat.

The findings were:

1. On 5/11/2010, a review of sample patient #1's medical record revealed the following: s/he was an 86 year old patient admitted on 2/27/2010, for small bowel obstruction and who underwent surgery to unblock the obstruction on this date. S/he required continued ventilatory assistance due to respiratory insufficiency and was transferred to the intensive care unit (ICU) where s/he inadvertently received a large bolus of the medication Propofol shortly after arrival. The patient became unresponsive with a severely low blood pressure and required resuscitation fluid and additional medication. The patient remained hospitalized for 24 days and was transferred on 3/23/2010, to a skilled nursing facility with weakness, some memory loss, dysphagia, a urinary catheter, and cecoileostomy drain following a second surgery for Ogilvie Syndrome. Her/his prognosis was good according to the primary physician.

2. An interview with the Director of Quality and Risk Management on 5/11/2010, at approximately 10:15 a.m., revealed the following: a hospital investigation of the occurrence revealed that a ICU nurse had inadvertently given the patient a large amount of Propofol. The ICU utilizes 2 pumps, single and triple pumps. Propofol is pre-programmed into the single pumps, but cannot be pre-programmed into the triple pumps. A nurse must manually enter the data. In this case, a bottle of Propofol was hung on a triple pump and the nurse incorrectly programmed the rate of administration such that the patient was given the entire amount in a short period of time.

The facility identified issues that needed to be addressed to help prevent a similar occurrence including revision of 2 policies. The first policy titled, "Medication Administration", would require 2 registered nurses (RN's) to verify dosage and orders for Propofol as a high-risk medication. The policy had been approved by the Nurse Practice Council on 5/05/2010, but not the Governing Body at the time of the survey. The second policy titled, "Post-op Recovery in ICU", would delineate nurse responsibility for recovery of a patient in the ICU (intensive care unit). Previously, both ICU and PACU (post anesthesia care unit) staff recovered a patient. Hand-off communication would occur, but only one nurse would be primarily responsible for the patient in the ICU. This policy was scheduled for completion 5/31/2010.

During the interview the Director made a call to the Pharmacy Director (as owner of the Medication Administration policy) and requested a final draft. S/he brought this to the surveyor approximately 10 minutes later. The Director asked the pharmacist if a blast email regarding the change in policy had been provided to the staff as of this date. The pharmacist stated no, but would do so today.


3. An interview with the Director of ICU on 5/11/2010, at approximately 10:40 a.m., revealed that s/he had a staff meeting on 3/24/2010, at which time the medication and pump issues were discussed. Even though the policy for Propofol as a high-risk medication requiring 2 RN verification had not been finalized, staff had started doing this following the incident. If a staff member was absent from a meeting, the ICU Director would follow up personally with the individual. S/he stated all staff had been appropriately educated regarding the issues, but s/he did not have documentation showing evidence that education had been completed for 100% of staff. S/he provided minutes from a 3/24/2010, staff meeting in which, three nurses were absent.

The surveyor asked the Director about other medications that could not be pre-programmed into the triple pump. S/he did not know as the list of possible medications was quite long. When asked if a sign had been placed on the pumps or poles to alert staff about the issue, s/he stated no. As a result of the interview, the Director stated s/he would research all potential medications that could not be pre-programmed and required manual programming to see if staff needed further education regarding administration of these medications.

The Director stated that both s/he and the Chief Medical Officer had spoken with the nurse after the incident. The nurse was very remorseful and took full responsibility for her/his actions. It was not an educational issue as s/he was aware that the triple pumps did not have pre-programming capability; s/he just programmed the pump incorrectly in the rush of admitting the patient to the ICU. In addition, the Chief Nursing Officer met with the nurse following the incident and a meeting of the Medication Team. No documentation of these meetings was provided to the surveyor.

4. A review of the personnel file for the nurse on 5/11/2010, revealed that s/he had been employed since 9/20/2005, and was a stellar employee based on previous evaluations. S/he had appropriate certifications for life support resuscitation and trauma patients. There was a job description and current license on file. There were no counseling reports in the file.

In summary, although the adverse patient event was the result of human error by a nurse incorrectly programming a pump set to deliver a high-risk medication, the hospital identified systemic issues that needed to be incorporated to help prevent a similar occurrence in the future. However, action plans including education of all nursing staff were incomplete, intravenous pumps identified as potentiating medication errors due to a lack of safety features had not been removed or tagged with information helpful to a nurse, and more research regarding medications and staff education was still pending. The hospital failed to adequately support its nursing staff to effectively administer medications within accepted practice standards.