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Based on document review and interview, the hospital failed to ensure that the Quality Assurance Performance Improvement (QAPI) program analyzed causes of 3 of 4 adverse events in accordance with their policy for Root Cause Analysis (RCA) and failed to ensure the program implemented preventive actions that included learning throughout the hospital.

Findings include:

1. Review of the policy titled Sentinel Event - Root Cause Analysis Process, approved 6/27/18, indicated the following:
Definitions:
Sentinel Event: An unexpected occurrence involving death or serious physical or psychological injury or any significant process variation for which a recurrence would carry a significant change of a serious adverse outcome.
Root Cause Analysis: The process for identifying causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.
Action Plan: The product of an RCA that identifies the strategies that the organization intends to implement to reduce the risk of similar events occurring in the future.
Action Plan:
To be acceptable:
Identify change that can be implemented to reduce risk, or formulate a rational for not undertaking such changes.
Where improvement actions are planned, identify when the action is to be implemented, including any pilot testing and how the effectiveness of the actions are to be evaluated.
Thorough:
To be thorough the root cause must:
Provide inquiry into all areas appropriate to the specific type of sentinel event as described in Table A-1 Root Causes in the form, "Framework for Root Cause Analysis and Corrective Actions".
Procedure:
The sentinel event Core Team: Determine if the occurrence meets criteria for a sentinel event: If YES: Implement the formal Root Cause Analysis process as outlined below: If NO, or carries a "risk thereof" possibility: Decide whether a RCA should be performed or the event should be handled through other PI/RM (Performance Improvement/Risk Management) processes. The phrase "or risk thereof" includes any process variation for which a reoccurrence would carry a "significant" chance of a serious adverse outcome.
RCA Core Team:
Team members are responsible to develop and re-design the process if indicated, and implement an action plan as appropriate. The team should:
Evaluate other areas or services impacted by or related to the event.
Notify and educate appropriate personnel affected by the changes.
Completing the RCA Form:
Document on the RCA form all other areas that may be affected and why.
Include all minutes of team meetings to the RCA.

2. Review of facility incident reports (IR) indicated the facility logged 5 patient incidents involving 4 significant unsafe infusion pump process variation(s) for which a recurrence would carry a significant chance of a serious adverse outcome. Incident reports indicated the following for patients as indicated:

A. RE: Patient P1. Date/Time of Event: 12/8/18 at 11:05AM. Primary Location: ICU/PCU (Intensive Care Unit/Progressive Care Unit). The report indicated the patient (P1) received an incorrect amount of a high alert medication due to variances between the pump library settings and standard administration dosing and in part due to an incomplete physician's order as follows: The patient was ordered to "start at 2 of Versed". The pump was "programmed at 2, which the option on the screen was for kg/hr". The nurse realized the bag of Versed went in fast. Patient's nurse and administering nurse looked at a guide that indicated "mg/hr is usually ordered". Patient received approximately 75 mg in less than 2 hours. The IR indicated the facility would conduct an RCA and the investigation was closed on 1/15/19. The RCA form lacked documentation of all other areas that may be affected and why.

B. Incident reports indicated that 2 incidents were filed in reference to patient P2. The reports were indicated to be related to the same unexpected occurrence, and a like occurrence, that without change could result in a serious adverse event. Details were as follows:
Date/Time of Event: 1/11/19 at 8:00AM. Primary Location: "ICU/PCU". The report indicated that the "infusamat pump" being used for the patient (P2) was not able to be programmed using the standard dose requirements "mcg/kg/min" for the medication ordered (Dopamine), a high alert medication. The report further indicated that the reporting nurse "called the pharmacist on call to assist with calculating the dose in ml/hour to program the pump". "He/she stated that a dose of 12.5 ml/hour was arrived at." "When the pharmacist and primary nurse rechecked the calculation it was determined that the proper dose should have been 75 ml/hour." The RCA form lacked documentation of all other areas that may be affected and why. The IR lacked documentation of the facility conducting an RCA. The IR indicated the case was closed on 1/24/19.
Date/Time of Event: 1/11/19 at 12:51AM. Primary Location: "ICU/PCU". The report indicated that it was noted while initiating a "Dopamine infusion" that the IV (intravenous) pump read in "mg/hr" instead of "mcg/kg/min". The same report further indicated that the reporter also noted "Levophed" (another high alert medication) concentration(s) on the IV pump to "not match" with what the hospital used. The IR form lacked documentation of all other areas that may be affected and why. The IR lacked documentation of the facility conducting an RCA. The IR indicated the case was closed on 2/11/19.

C. RE: Patient P4. Date/Time of Event: 1/20/19 at 10:21AM. Primary Location: "ICU/PCU". The report indicated that the physician ordered "Dopamine drip to start at 10mcg/kg/min to keep MAP at 65". (MAP = Mean Arterial Pressure). The reporter indicated that when trying to start the infusion for patient P4, the pump would "only allow the medication to be programmed by mg/hr". The report indicated that nursing staff calculated a mg/hr dose to be 36.6mg/h, but the pump would only allow a maximum (max) of 20mg/hr and the "typical MAX dose of dopamine is 20mg/kg/min, not 20mg/hr." Therefore, the pump would not allow the proper dose of medication to be administered at the "initial rate of 10mcg/kg/min". The IR form lacked documentation of all other areas that may be affected and why. The IR lacked documentation of the facility conducting an RCA. The IR indicated the case was closed on 1/24/19.

D. RE: Patient P3. Date/Time of Event: 1/24/19 at 10:00AM. Primary Location: Cardiology. The report indicated the patient (P3) was ordered a dobutamine (high alert medication) stress test. The IR indicated that when the nurse attempted to enter the patient and dose information into the pump, the following occurred: The concentration of the bag of dobutamine which was 4000mcg/ml was selected. The patient's weight in kilograms (kg) was entered and then the starting rate of 5mg/kg/min was selected. At that point, the nurse indicated he/she noted that the "ml/hr rate was high". The nurse/reporter, then indicated he/she rechecked all entries and noted all to have been correct. The reporter indicated that upon a 3rd attempt, the pump was still giving an incorrect rate, "a lethal rate" of infusion. The reporter noted that he/she was "instructed that pharmacy and educator knew of the issues and all drips "had to be put in as a generic infusion" and bypass the safety entries in the IV pump. The reported indicated that he/she had not been notified to "not use the drug library/pump safety parameters. The IR form lacked documentation of all other areas that may be affected and why. The IR lacked documentation of the facility conducting an RCA. The IR indicated the case was closed on 2/4/19.

3. Review of the RCA document titled FRAMEWORK FOR ROOT CAUSE ANALYSIS AND CORRECTIVE ACTIONS indicated the the facility had performed a RCA for the incident related to patient P1. The RCA lacked documentation of inquiry into all areas appropriate to the specific type of event, lacked documentation of all other areas affected and why and lacked documentation of team meeting minutes.

4. Review of facility documents, lacked documentation of the QAPI program having conducted RCAs for incidents involving patients indicated as P2, P3 or P4.

5. Review of facility documents lacked evidence of preventive actions that included education throughout the hospital.

6. On 2/19/19, between approximately 4:00 p.m. and 5:00 p.m., A2, Director of Performance Improvement, verified the hospital had not performed RCAs for 3 of the 4 pump related incidents. A2 indicated agreement that the pump related incidents were of high significance and could have caused a sentinel event. A2 verified that the RCA review for patient P1 did not include the potential for the issue to occur in other areas of the hospital and did not include meeting minutes. A2 also verified that the infusion pumps travel throughout the hospital and could be used in any area.

7. On 2/18/19, between approximately 4:00 p.m. and 4:45 p.m., A5, Director of Nursing, indicated he/she was aware of nursing having issues with the infusion pump drug library's not matching medication concentrations for dosing. On 2/19/19, between approximately 4:00 p.m. and 5:00 p.m., A5 verified that the facility lacked documentation of all nursing staff having received notices and/or education.

Based on document review and interview, the hospital failed to ensure that the director of nursing services carried out responsibilities as established in corrective action plans and in accordance with policy for 1 of 1 root cause analysis (RCA) performed within the past 3 months.

Findings include:

1. Review of the policy titled Sentinel Event - Root Cause Analysis Process, approved 6/27/18, indicated the following:
To be "thorough" the root cause must: Provide inquiry into all areas appropriate to the specific type of sentinel event as described in Table A-1 Root Causes in the form, "Framework for Root Cause Analysis and Corrective Actions".
The RCA Team members are responsible to:
Evaluate other areas or services impacted by or related to the event.
Notify and educate appropriate personnel affected by the changes.
Completing the RCA form:
Document on the RCA form all other areas that may be affected and why.

2. Review of the document titled FRAMEWORK FOR ROOT CAUSE ANALYSIS AND CORRECTIVE ACTIONS indicated the following:
Corrective Actions:
Action Item #5: Educate nursing r/t (related to) IV pump update and protocol. Completion Date: Jan 10, 2019.
The RCA lacked documentation of inquiry into all areas appropriate to the specific type of event, lacked documentation of other areas that may be affected and why and lacked documentation of how nurses would be educated on IV pump update and protocol.

3. Review of the document titled Staff Meeting, Date & Time: "Mandatory Staff Meeting January 8 & 15", indicated topic 6 to be High Alert medications. Discussion and Outcome/Action included infusion pump "rebuilding" and protocols, however, the minutes lacked documentation of any "Attendees".

4. Review of an email dated 12/12/18, from A5, Director of Nursing, indicated nursing staff was notified of administration working on the drug library update. The email lacked documentation of education related to the update or protocol to be followed. The email lacked documentation of having been sent to all nursing staff, including but not limited to 1 of 1 cardiology department nurse, A8.

5. Review of the email dated 1/4/19, from A5, indicated notice to obtain assistance from pharmacy with critical IV drugs and use the "Adult Concentration and Titration Guide" was sent to 46 of 71 nursing staff.

6. Review of the email dated 1/16/19, from A5, indicated notice of the manufacturer to rebuild the "library" and information that "Updated protocols and order sets will follow", was sent to 65 of 71 nursing staff.

7. Between approximately 4:00 p.m. and 5:00 p.m., A5 indicated he/she sent notification to nurses as indicated in the RCA and provided email documentation. A5 verified that the emails lacked documentation of all nursing staff having received notice(s)/education.