HospitalInspections.org

18559

Based on record review, governing body bylaw review, governing board meeting minutes review, event reporting review, root cause analysis (RCA) review, interview, policy review, and job description review, the provider's governing board failed to ensure:
*Pharmacy and nursing services worked in collaboration to review and provide preventative action plans for two medication administration errors that resulted in a sentinel event (unanticipated event resulting in harm or death).
*A quality assurance program had been put in place to provide review, immediate correct action, and monitoring of interventions for medication administration errors.
Findings include:

1. Review of patient 1's medical record, 1/10/21 events reporting, and 1/12/21 RCA revealed:
*A medication administration error had occurred during his stay.
*He had received hydralazine (blood pressure medication instead of hydroxazine (anxiety) on 1/10/21.
*The medication administration error had resulted in his transfer to a higher-level of care facility on 1/10/21.
*There was no specific date documented on the RCA for staff education to have been completed.
*There was no documented education or competencies for all staff on med administration after this significant med error occurred.

Review of patient 2's medical record, events reporting, and RCA revealed:
*A medication administration error had occurred during his stay.
*He had received an incorrect dose of Detemir insulin on 8/22/20.
*The medication administration error had resulted in his transfer to a higher-level of care facility on 8/22/20.
*All nursing staff had been required to:
-Complete insulin medication administration education.
-Review the Medication Administration and Medication-High Alert policies.
*The deadline for completion of the education and review of those policies had been documented as 9/30/20 (39 days after the incident).

Interview on 1/27/21 at 9:35 a.m. with RCNO F and regional quality risk officer G revealed:
*The pharmacist and the CNO should have worked together when investigating med errors.
*The pharmacist is responsible for all medication from the time the it had entered the facility until the medication leaves the facility.
*They agreed the process would have improved with the incorporation if the pharmacy services into the education portion of the med administration error.
*From the time of dispensing the medication the burden falls on nursing but pharmacy does have input.
*RCNO F stated: "Even though the med error that happened with [patient 1's name] was unfortunate, I do not believe education and competencies had to be done for everyone. I see this as an isolated incident and the risk of it happening again is low."

Refer to A385, findings 1-4 and A489, findings 1-5.

2. Review of the provider's governing body meetings dated 8/18/20 and 11/13/20 revealed:
*Medical director P, chief executive officer (CEO) A, regional quality risk officer G, and chief nursing officer R were the four members of the governing body.
*Medication events had not been documented for action or discussion from the information presented by the performance improvements/outcomes at the 8/18/20 meeting.
*Medication events had been documented for action or discussion with a 1/1/21 follow-up date for staff education at the 11/13/20 meeting.

3. Review of the provider's 2/18/20 Governing Body Bylaws revealed the governing body was responsible:
*For "The implementation and maintenance of a Hospital-wide program for the assessment, maintenance, and improvement of the quality of patient care and safety, and the reduction of medical errors."
*To "Ensure that adequate resources are allocated for measuring, assessing, improving, and sustaining the Hospital's performance and reducing risk to patients."
*The governing board was required to meet one time each quarter of the year.

4. Interview on 1/27/21 at 2:15 p.m. with CEO A revealed significant med errors require immediate action by the management team and should have been addressed with further education, training, and competencies for all the nursing staff. He confirmed the med administration errors had not been discussed and reviewed at the governing board meetings and they should have.

5. Review of quality council meeting minutes review, quality assurance data log review, medication errors performance improvement group meeting minutes review, root cause analysis and action plan review, and interview revealed:
*The quality council's benchmark for medication administration errors had not been met for August 2020.
*Twenty six medication administration errors including two sentinel events had been noted in the medication errors performance improvement group meeting minutes.
*Staff education for medication administration had been required to be completed by 1/31/21 (102 days after the meeting).

Refer to A263, findings 1-3.

Surveyor: 32355
6. Review of the provider's 5/18/20 Education Plan policy revealed:
*"The Governing Body of (provider's name) delegates the authority and responsibility of the education plan to the Human Resources Director with input from the Leadership Team and Quality Council."
*"Program outcomes, staff input, and performance improvement recommendations will be utilized in the development of a plan to deliver programs assuring the highest obtainable level of understanding and knowledge to continually improve clinical performance."
*"The plan is to be implemented through joint responsibility of the Human Resource Director and the Department Leaders."
*"The Human Resource Director, with guidance from the Medical Executive Committee shall annually assess the need for revision of the plan."

Review of the provider's 5/18/20 Sentinel Events policy revealed:
*"The hospital's Governing Body is responsible for the oversight of the reporting, analysis, and prevention of Sentinel Events and for consistent and effective efforts to carry out this responsibility including:
-Reviewing this policy annually to determine whether, considering the setting and population served, quality and risk trending data and state-specific requirements, the definition of Sentinel Events should be expanded.
-Tracking all adverse events, no-harm events, near misses/good catches and unsafe conditions, in addition to Sentinel Events and using the information as opportunities to prevent harm.
-Training of all hospital staff annually regarding the events considered to be Sentinel Events and the site-specific process for reporting.
-Arranging for the review of the action plan of each RCA [Root Cause Analysis] and modified RCA by the appropriate staff/committee."

Review of the provider's unsigned and undated Chief Executive Officer job description revealed:
*"The CEO is responsible for all day-to-day operations of the hospital."
*"This position is accountable for planning organizing and directing the hospital to ensure that quality patient care is provided."
*"The CEO ensures compliance with applicable laws and regulations as well as all policies and procedures set forth by the Governing Board and Medical Staff, and those required by Joint Commission Standards."
*The CEO is responsible for:
-"Holding staff accountable for performance."
-"The operation of measurement, assessment, and improvement of the hospital's performance."
*"Creates opportunities to promote superior patient satisfaction and outcomes."
*"Demonstrates commitment to improve quality and safety through training, education, communication, collaboration, innovation, and execution."
*"Considers patient and staff safety, takes initiative to identify and eliminate risks, and educates patients, families and team in those strategies."

18559

Based on record review, quality council meeting minutes review, quality assurance data log review, medication errors performance improvement group meeting minutes review, root cause analysis (RCA) and action plan review, job description review, and interview, the provider failed to ensure a quality assurance program was in place to review, provide timely interventions, and monitor interventions effectiveness for 26 medication administration errors. Findings include:

1. Review of the provider's 11/6/20 quality council meeting minutes revealed:
*(CEO) A, quality/risk director B, chief nursing officer (CNO) R, nurse educator E were on the quality council.
*No additional quality council meetings had been held.
*Medication events (medication administration errors) had been documented as an outlier which required action and discussion.
*Medication administration education of staff had been documented for follow up with a target date of 1/1/21 for completion (102 days after meeting).

Review of the provider's 3/17/20 Performance Improvement Plan policy revealed:
*The governing body is the ultimate authority and is committed to the provision of quality and safe patient care and services.
*Quality council meetings should have been held quarterly.
*A proactive approach should be used to:
-Assess the intended and actual implementation of the process to identify potential failure modes.
-Identify the possible effects to the patient and the severity.
-For critical effects conduct a root cause analysis to determine the cause of the failure.
-Change the process to minimize the risk of the failure and protect the patients.
-Test and implement the new process.
-Implement a strategy for maintaining the effectiveness of the new process.
*The planning of data collecting should be timely in intervals that allow for the effective assessment, conclusions, and recommendations.

Review of the provider's quality assurance data log for August 2020 revealed:
*Medication events were documented at 14.57% with a benchmark of 13.0%.
*The action plan section of the log for medication events had been left blank.

Review of the Medication Errors Performance Improvement Group quarterly meeting minutes for 9/28/20 and 12/17/20 revealed:
*From 6/1/20 through 9/28/20 there had been 20 med errors.
*At the initial meeting on 9/28/20 the following was reviewed and discussed:
-A trend had been identified with meds not being given and incorrect dosing.
-Out of those 20 med errors only 2 nurses had received additional training on med administration.
-The chief nursing officer (CNO) thought time management was an issue and she would continue to remind the staff to immediately review their patients upon checking in for their shift.
-The nurse educator was to have reviewed the provider's ACEIT program for education on their med administration bullet points. One topic a week was to be chosen and reviewed during the staff huddles (report), as well as for staff meetings.
*At the second meeting on 12/17/20 the following was reviewed:
-There had been an additional six more med errors since their last meeting.
-A trend in omission had been identified.
-No particular staff had been identified with re-occurring med errors so no additional training on med administration had been done.
-There was no follow-up regarding the ACEIT program weekly education the nursing staff were to have reviewed during their shift huddles.

Interview on 1/27/21 at 5:20 p.m. with regional chief nursing officer (RCNO) F, quality/risk director B, and CEO A revealed:
*Medication administration will be discussed at the next governing board meeting scheduled on 2/11/21.
*A medication error committee had been established and was relatively new.
*The first meeting was in September 2020 and the committee had started in August 2020.
*They agreed the committee had not met as often as they should have for reviewing medication administration errors.

Interview on 1/26/21 at 5:25 p.m. with RCNO F, quality/risk director B, pharmacist H, and regional quality risk officer G revealed:
*RCNO F stated: "The double witness for all medication administration was in a policy but was not required to be performed."
*They have not created a specific policy for insulin or blood pressure medications.
-RCNO F stated: "The policy and procedure is in the Pyxis and physician's orders. The staff are supposed to follow that process."
*Pharmacist H felt the double check for insulin had been working.
-The double checking of insulin was during the preparation phase only. The nurses' had been able to administer the insulin independently without a witness.
*Quality/risk director B stated they had not had a quality council meeting in October 2020.
-She had other obligations and they were never able to find the time to reschedule it.
*Regional quality risk officer G confirmed no policies had been reviewed and updated since the two sentinel medication administration errors had occurred.

Surveyor: 32355
2. Review of the provider's 3/17/20 Safety Plan policy revealed:
*"The purpose of the Safety Program is to improve patient safety and reduce risk to patients, staff, and visitors."
*Responsibility:
-"The ultimate responsibility for the implementation and operation of this Plan is vested in the hospital CEO."
-"The CEO has delegated day-to-day monitoring and function of this Plan to the Director of Quality/Risk (DQR)."
-"The Safety Committee and Quality Council will provide interdisciplinary input and oversight related to patient, visitor, and staff safety."
*The plan requires:
-"Staff will be oriented to the Safety Plan on hire, as well as risks specific to their role, and through ongoing inservice and other education and training programs, as needed."
-"Electronic Event Reporting describes the process for reporting of every occurrence which meets the following definition: any happening not consistent with the routine care or operation of the facility, or the desired routine care of the patient and/or operation of the facility, which places our patients and visitors at increased risk for harm."
-"The DQR or designee will respond promptly to notification of significant safety events to a patient/visitor."
*"The Governing Board has appointed the DQR as the Patient Safety Officer. The Patient Safety Officer/Director's role includes:"
-"Participating in hazard surveillance, event reporting, reviewing, and the development of patient safety policies and procedures."
-"Analyzing and seeking resolution of patient safety issues and works with the appropriate staff to implement recommendations and to monitor patient safety improvement activities."
-"Report on findings, recommendations actions taken, and results of measurements through the hospital quality structure."
*"Hospital leadership will measure and assess the effectiveness of their contributions to improving patient safety."

Review of the provider's 5/18/20 Sentinel Events policy revealed:
*"The Governing Body/Quality Committee has delegated the task of investigation of adverse events, to include sentinel events, to the DQR, and the DQR may designate individuals to assist with investigations as needed."
*"These Sentinel Events are considered "reviewable" as they typically require review with Home Office Risk Management and Quality & Clinical Excellence."
*"The hospital CEO/designee and/or the DQR will be responsible for initiating a timely and thorough multidisciplinary RCA."
*"It is the responsibility of the hospital CEO to ensure compliance with this policy within the hospital."

Review of the provider's unsigned and undated Quality/Risk Director job description revealed:
*"The Quality/Risk Management Director is responsible for helping to create an environment and culture that enables the facility to fulfill its mission by meeting or exceeding its goals, conveying the hospital mission to all staff, facilitating staff accountability for their performance, and motivating staff to improve their performance."
*"The Director ensure proper compliance with regulatory agencies, accrediting bodies, corporate and hospital policies and procedures and works to develop, implement, and maintain quality assessment and improvement programs within the facility."
*"Assess compliance with federal, state, and industry regulatory and accreditation standards, facilitating processes to remediate and/or maintain compliance."
*"Provides organizational education related to the regulations and standards."
*"Coordinates the review, revision, development, approval and implementation of hospital specific policies."
*"Communicates and collaborates with other departments to coordinate care and promptly resolve customer concerns or complaints as outlined in the HealthSouth Corporate Patient Complaint/grievance Policy."
*"Oversees complaint process including complaint investigation; verbal and written complaint follow-up; corrective action planning; and maintenance of complaint log."

3. Review of patient 1's medical record, 1/10/21 events reporting, and 1/12/21 RCA revealed:
*A medication administration error had occurred during his stay.
*He had received hydralazine (blood pressure medication) instead of hydroxazine (anxiety) on 1/10/21.
*The medication administration error had resulted in his transfer to a higher-level of care facility on 1/10/21.
*No specific date had been documented on the RCA for staff education completion.
*There was no documentation to support education or competencies for all staff had occurred after this significant med error occurred.

Review of patient 2' medical record, events reporting, and RCA revealed:
*A medication administration error had occurred during his stay.
*He had received an incorrect dose of Detemir insulin on 8/22/20.
*The medication administration error had resulted in his transfer to a higher-level of care facility on 8/22/20.
*All nursing staff had been required to:
-Complete insulin medication administration education.
-Review the Medication Administration and Medication-High Alert policies.
*The deadline for completion of the education and review those policies had been documented as 9/30/20 (39 days after the incident).

Refer to A385, findings 1-4 and A489, findings 1-5.

Based on observation, interview, medication/fluid event form review, root cause analysis event form review, job description review, and policy review, it was determined the provider failed to ensure:
*Nursing services and pharmacy services had worked in collaboration to ensure the patients were safe from medication (med) administration errors from 6/1/20 through 1/25/21 for twenty-six med administration errors.
*Immediate corrective action was taken for 1 of 26 med errors which involved the incorrect administration of 40 units of long-acting insulin rather than the 4 units ordered by the physician for 1 of 10 sampled patients (2).
-This required the patient to be transferred to a higher-level of care for observation of his status.
*Immediate corrective action was taken for 1 of 26 med errors which involved the administration of a blood pressure (b/p) lowering med for 1 of 10 sampled patients (1).
-This resulted in the need for CPR and transfer to a higher-level of care.

These failures have the potential to lead to serious harm, injury, impairment, or death.

NOTICE:
On 1/27/21 at 11:16 a.m. Immediate Jeopardy was identified when the provider failed to implement nationally recognized standards for med administration. The chief executive officer (CEO) was presented the Immediate Jeopardy Template on 1/27/21 at 11:16 a.m.

PLAN:
The facility provided the following acceptable removal plan on 1/27/21 for pharmacy and nursing services:
*Description of At-Risk are of Non-compliance: "One patient received 40 units of insulin vs the required 4 units ordered for long acting insulin. This required a transfer to a higher level of care provider for close and one-on-one observation for 24 hours."
-Detailed Description of action taken: " Root Cause Analysis (RCA) completed on September 11, 2020. In addition to the actions taken from finding of RCA education on insulin will be provided to staff immediately of those who are working. All on-coming staff will receive education prior to start of shift. Training will be provided by both the Interim CNO (chief nurse officer) or designee and DOP (director of pharmacy) or designee. Email education to all RNs and LPNs containing above education will be distributed on 1/27/2021."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Observation of signal dose of insulin administration will begin today, 1/27/21, with nurses. This observation will continue until 100% of all licensed nurses have been observed. Interim CNO and DOP will sign off on observation completed. All staff will be observed on their next scheduled shift. Observations will be completed 2/2/2021 or by end of next schedule shift by the interim CNO or designee and DOP or designee."
--"An attestation will be created for all RNs and LPNs to sign for confirmation of education."

*Description of At-Risk are of Non-compliance: "One patient received a prn [as needed] medication to lower blood pressure (b/p) instead of an anti-anxiety medication. The medications are classified as "look alike, sounds alike." Within 20 minutes of receiving this medication the patient coded requiring life sustaining measures and EMS notification for transfer to a higher level of care facility. Two days post event the patient expired."
-Detailed Description of action taken: "Education on look-alike sound-alike and proper use of PRN medications on orders as appearing on MAR (medication administration record) will be provided to RNs and LPNs immediately of those who are working. Email education to all RNs and LPNs containing above education will be distributed on 1/27/2021. Education on all on-coming RNs and LPNs will receive education prior to completion of their next scheduled shift. Training/inservice will be provided by both the CNO or designee and DOP or designee. An attestation will be created for all RNs and LPNs to sign for confirmation of education."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Interim CNO and DOP will sign off on look alike sound alike medication and proper use of PRN medications education as attested to by RNs and LPNs upon completion."

*Description of At-Risk are of Non-compliance: "Lack of pharmacy collaboration and oversight with nursing services for 26 medication administration errors from 6/1/20 thru (through) 12/17/20. This would include 2 significant medication administration errors. Both resulting in a transfer to a higher level of care. One resulting in death."
-Detailed Description of action taken: "Interim CNO or designee and DOP or designee will jointly review RL Solutions-Healthcare Risk Management Software (RL6) event reporting system for medication/fluid events to determine if any actions are needed to be taken. The Interim CNO and DOP will be required to sign-off on medication events starting January 27, 2021, moving forward."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Trends will be referred and reviewed in the Medication Error Performance Improvement Team, that will be meeting monthly, with results reported quarterly to P&T (Pharmacy & Therapeutics), MEC (Medical Staff), and to GB (Governing Board)."

The removal plan was reviewed and accepted by the surveyors on 1/27/21. The implementation of the plan was verified and their Immediate Jeopardy status was removed on 1/27/21 at 6:15 p.m.

Findings include:

1. Observation and interview on 1/25/21 at 2:43 p.m. with RN Q during her med pass for patient 3 revealed:
*She:
-Entered his room with her med cart and pulled up his medication administration record (MAR) on the computer screen.
-Asked him to verify his name and birthdate and scanned his identification band to confirm his identity.
*Three meds appeared on the med MAR for her to administer to him.
-Those meds were gabapentin (for nerve pain), Lasix (removes extra fluid), and Clonidine (lowers b/p).
*She stated: "The screen will only show the meds he needs to get within the next two hours."
-That would not have included as needed (prn) meds.
*There was a box located next to the Clonidine order on the MAR and was highlighted pink in color.
*The surveyor asked what the pink color meant by the med and the she stated:
-"That is confusing, typically with b/p meds that box will be yellow if further information is needed before we give it."
-"If you had not asked about it, I might not have even checked on it."
*She:
-Clicked on the pink box and there were b/p parameters for holding the med which required a current b/p and pulse to be entered prior to administering the Clonidine.
-Was able to give him his med after she checked his b/p and pulse.
*She stated:
-"I don't know why that box wasn't yellow."
-"Usually if the b/p med requires us to do something before giving it, it will be yellow."
-"I don't think all b/p meds flag yellow except for Midodrine [increases b/p]."
-"There are other safety checks for meds though, like Tylenol it will alert you on max dosing."
-"Pain meds require further information on their pain status before giving."
-"There are look alike sound alike meds too."

Continued interview on 1/25/21 at 2:50 p.m. with RN Q regarding "Look alike Sound alike" meds revealed:
*She was aware that recently a patient had received a med by mistake that was classified as a "Look Alike Sound Alike" med.
*She stated:
-"I wasn't here that day but I heard about it."
-"A nurse gave a patient hydralazine [lowers b/p] instead of hyrdroxyzine [for anxiety, allergies]."
-"She thought she was giving hydroxyzine."
-"Hydralazine is pretty much ordered prn for all the patients. You see it a lot on the MARs."
-"I'm not sure if it has any alerts or not when giving it."
-"It does come ordered with b/p parameters though."
-"You just really need to pay attention."
*She had heard about the med error in their huddle meetings (shift change).
*She stated:
-"We were told to pay close attention and be mindful of what we are giving the patients."
-"No, we never had any formal education on this med error after it occurred and no, I have not been watched giving meds since I first started back in June."
-"Yes, I think there should have been some type of education or training for the nursing staff after that med error. That was serious."
-"But if you give the wrong med you're just not paying attention because this system has so many safety checks when giving meds."
-"You literally would have to be rushing or not giving meds the way you are supposed to."

Observation and interview on 1/25/21 at 3:40 p.m. with RN Q revealed:
*She had prepared to take meds out of the Pyxis machine for administration.
*The Pyxis machine had a computer screen for her to find the patient she needed and a list of their meds.
*Once RN Q had verified the med she wanted for a specific patient a drawer opened up where the med was located.
*Inside of the drawer was:
-Several square boxes with meds inside of them.
-The boxes were secured shut with clear lids that you could see through to identify the meds inside of them.
*Some of the lids had caution stickers or labels on them.
-Several lids had yellow stickers on them identifying the med inside of the box as hazardous.
-Some lids had the words "Look alike Sound alike" on them.
*She stated:
-"This is what I'm talking about. There are so many safety measures within this system that you really would not be following the process or paying attention to what you are doing to make an error."
-"To my knowledge I have not made a med error. The system usually catches me or stops me in some sort of way before I do."

Review of patient 1's medical record revealed:
*He was admitted on 12/21/20 and discharged to a higher-level of care on 1/10/21.
*His diagnoses included a history of:
-Guillain-Barre Syndrome (the immune system attacks the nerves) that had recently worsened related to the onset of COVID-19 (viral infection) on 11/30/20.
-Pneumonia, paresthesia (tingling or prickling sensations of the skin), weakness with limited movement in his upper and lower extremities, periods of altered mental status, depression, and anxiety.
-A loss of appetite due to COVID-19 that had resulted in protein calorie malnutrition.
-Hallucinations and night terrors that required the use of an anti-psychotic med (Seroquel).
-Hypertension that was being treated with three different types of antihypertensive medications upon admission.
*On 12/21/20 hydralazine 20 milligrams (mg) was ordered by the physician to be given prn every four hours for when his systolic b/p was greater than 160 mmHg (millimeters of mercury).
-There was a reminder attached to this order that the med was a LASA (Look alike Sound alike).
*After his admission it was noted that he had extremely low blood pressures when sitting and all the antihypertensives were gradually discontinued.
-On 12/29/20 the physician ordered him Midodrine 2.5 mg three times a day (TID) for pressure support.
-The order for prn hydralazine was never discontinued.
*He was dependent upon the staff to develop and implement his plan of care (POC).
-That POC included the preparation and administration of his meds per physicians' orders.
*He was alert and oriented with periods of increased confusion and anxiety.
-During those episodes of increased anxiety and confusion he often complained of pain and a tingling sensation in his feet/legs.
-For periods of increased agitation the physician had ordered Seroquel 12.5 mg twice a day (BID) prn.
*On 1/10/21 he:
-Had been experiencing some increased anxiety due to the tingling sensations of his feet/legs.
-At 12:59 p.m. he was administered a b/p lowering med instead of an anti-anxiety med for his increased agitation.
-Became unresponsive within twenty minutes of receiving that med and required life sustaining measures.
-The Emergency Medical System (EMS) was activated and he was transferred to a higher-level of care facility.
-Two days post event he expired at that facility.

Review of patient 1's 1/10/21 medication/fluid event form revealed:
*At 12:59 p.m. he was given a med that was used to lower blood pressures.
-That med was hydralazine and was commonly mistaken for hydraxazine.
*He already had hypotension and was receiving Midodrine TID for pressure control.
*Twenty minutes after receiving the hydralazine he coded (became unresponsive).
*Final outcome: He was immediately transferred to a higher-level of care.

Review of patient 1's 1/12/21 root cause analysis event form revealed:
*At 12:59 p.m. the patient was given the incorrect med for anxiety by RN L.
*Brief actual description:
-"The patient was anxious and she [RN L] asked the nurse supervisor if she should give him Seroquel, as patient has this on his medication administration record."
-"Nurse supervisor told her [RN L] to give the patient hydroxazine for his anxiety, if he has it included in his MAR."
-"The nurse [RN L] went into patient's MAR and saw that he had a PRN medication for hydralazine, and gave the patient a dose. The patient did not have an order for hydroxazine."
-"In the patient's MAR, hydralazine is listed with parameters to be given ONLY if his blood pressure is elevated SBP [systolic blood pressure] > 160."
-"At 11:34 a.m. his b/p was documented at 80/49."
-"The MAR listed this medication as "Look Alike Sound Alike" and the Pyxis machine cubby for this medication was also labeled "Look Alike Sound Alike."
-"Approximately 30 minutes after the patient received the hydralazine he coded. CPR was performed and paramedics called."
-"The patient was transported to acute care hospital for higher level of care."
-"The RN stated she [RN L] saw "hydralazine" in the patient's MAR and did not look closely at when/how to give it, and assumed it was "hydroxazine" as that is what she was looking to give the patient for his anxiety."
-"She stated that she should have taken more time to read the MAR more closely."
-"The nurse [RN L] did not enter a blood pressure nor acknowledge a previous blood pressure in the MAR before she gave the hydralazine."
*There was no documentation to support staff education and med administration competency review had been set-up for the incident that occurred on 1/10/21 to ensure the risk of that occurring again had been removed.




18559

2. Review of patient 2's medical record revealed:
*He had been admitted on 7/31/20.
*His diagnosis was pneumonia, unspecified organism, malignant neoplasm to lower lobe left bronchus.
*He had an order for four units of Detemir insulin daily at 8:00 p.m.
*He had an order for 5,000 units of heparin every eight hours.
*The heparin and Detemir insulin dose had been missed on 8/4/20.
*On 8/22/20 at 8:00 p.m. licensed practical nurse (LPN) N administered 40 units of Detemir insulin instead of 4 units of Detemir insulin.
*Physician was notified of the administration error on 8/22/20 at 8:07 p.m.
*Patient was transferred via ambulance to a higher level of care facility on 8/22/20 at 8:45 p.m.

Review of the provider's 8/23/20 event report for patient 2 revealed:
*LPN N misread the quantity of Detemir insulin ordered.
*She had administered 40 units of Detemir insulin instead of four units of Detemir insulin.
*After administration she tried to document the 40 units into the MAR.
*The MAR indicated the 40 units was not the appropriate dose of insulin to be given. She reported the mistake to the RN supervisor.

Review of the provider's 11/2/20 root cause analysis and action plan for patient 2 revealed:
*LPN N should have entered the amount of insulin given to patient 2 into the MAR prior to administration to the patient.
*Per nurse supervisor O "I did not verify the dosage to the MAR when completing the double-check."
*Reasons for event occurrence given by LPN N were:
-Inability to focus on task.
-"Sometimes I don't see things as they are written."
-Personal problems with high anxiety when shift starts.
-Rushing to complete tasks.
-Lack of familiarity with patient.
-She did not feel she had adequate training.
-She only had two days of orientation prior to shift.
*Nurse educator E had not evaluated LPN N in medication administration prior to the event.
*Plan of action was:
-All nursing staff would be required to watch a video on proper dispensing, administering, and performing double check on insulin.
-All licensed staff would be required to review Medication Administration and Medication-High Alert policies.
-Nurse orientation modified to include up to eight weeks orientation.
-The due date for staff to watch the video and review the policies was 9/30/20. That would have been 39 days after the incident
-The orientation would be an ongoing task.
*Clearly preventable was selected on the preventability assessment.
*The review and approval of root cause analysis and action plan was signed by CEO A and quality/risk director B on 11/2/20.

Surveyor: 32355
3. Interview on 1/25/21 at 2:30 p.m. with RN Q regarding insulin administration revealed she:
*Stated:
-"There is supposed to be two of us when drawing up insulin."
-"One person is at the Pyxis reviewing the order while the other person is drawing it up."
-"Both of you have to have eyes on the syringe and double checking the dose before signing it off in the Pyxis."
-"We both have to sign for verification."
-"You cannot pull the insulin out of the Pyxis without another witness."
-"After that you can give it by yourself, you just cannot prepare it by yourself."
*Had been aware of the med error involving patient 2.
*Stated: "Again, someone wasn't paying attention or the process wasn't done right. There are just way to many safety checks."
*Was not aware of any:
-Education or training regarding insulin preparation or administration after that med error occurred.
-Competencies or monitoring of the staff while preparing or administering insulin after that med error.
*Agreed, there should have been education and training provided for the staff after that med error occurred.

Interview on 1/25/21 at 2:55 p.m. with quality/risk director B revealed:
*A med error for insulin administration occurred with [patient 2's name] in August.
*The nurse who made the error was the only one who was re-educated on insulin administration.
*The rest of the nursing staff were not re-educated as she felt it wasn't a system breakdown.
*She stated: "It was more of an isolated incident."

Interview on 1/26/21 at 8:00 a.m. with RN D regarding insulin and b/p med administration revealed she:
*Confirmed the above interviews with RN Q:
-Insulin preparation required two nurses to be present for verification of the right dose.
-You could administer the insulin on your own, but you could not prepare it without a witness.
-Blood pressure meds had safety checks and and would be yellow in color if further information was required prior to given.
*Stated:
-"You can't pull the insulin out of the Pyxis without another witness."
-"You can't sign off the b/p med as being given until you go further into the yellowed area and check to see what you need to do first."
*Could not recall any recent education, training, or med administration competencies on either of those two topics since her orientation upon hire.

Surveyor: 18559
4. Interview on 1/26/21 at 10:38 a.m. with Certified Nurse Practitioner (CNP) I revealed:
*Concerning patient 2:
-Her employment with the provider started after patient 2's incident.
-Patient was given a long acting insulin and would have required one to one monitoring for four hours.
-She would have transferred the patient.
-She agreed this was a significant error.
*She stated they should have two people for insulin administration.
*Concerning patient 1:
-On admission his orders had included a prn order for hydralazine for when his systolic b/p was greater than 160.
-Hydralazine was a potent vasodilator for lowering a high b/p.
-After admission they noticed his b/p's ran low when sitting and were decreasing his blood pressure medications.
-She felt the solution to solve this problem would have been to discontinue the hydralazine.
*She would have expected all staff to have been immediately educated after a significant event.
-An evaluation should have been done to determine if system error or human error.
*She would have expected competencies for all staff on insulin and b/p medication administration.
*Any education the medical staff provided to the nursing staff would have been verbal only.
*She agreed:
-The education should have been documented to support it had occurred.
-Those same medication administration events could happen again in the future.

Interview on 1/26/21 at 11:58 a.m. with nurse supervisor C revealed:
*She had started with the provider on either August 16 or August 19 in 2020.
*She was not aware of any insulin administration errors since her start date.
*There had to be two nurses in the medication room when drawing up and preparing the insulin for administration.
-One nurse would verify the insulin order in the Pyxis while the other nurse would prepare the insulin for administration.
-They should verify the patient's blood glucose level prior to administering the insulin.
-The insulin should then be locked in the patient's medication drawer until the nurse could administer it.
*Both of the nurses were required to check to make sure the insulin dose that was prepared for administration was correct.
*After those steps had been completed the nurse was able to independently administer the insulin.
*She agreed education is needed if a problem keeps occurring.
*Medical records system should flag yellow with all "Look Alike Sound Alike" meds for blood pressure mediation.
*The yellow flag required vital signs to be taken.
*The following education had been presented at the next nursing huddle following the 1/10/21 incident:
-Make sure to verify physician's orders.
-Remember to take a patient's b/p prior to administering b/p medication.
*There had been no formal education on med administration since the med error that involved patient one.

Interview on 1/26/21 at 12:32 p.m. with physician K regarding the med errors for patients 1 and 2 revealed:
*He had been notified by the nurse supervisor when patient 2's med error occurred.
*At the time of the event he had been working at another higher-level of care provider.
-He gave the nurse orders to have patient 2 transferred to that facility where he was working.
-The patient would require 24 hours one-on-one observation from receiving to much long-acting insulin.
*He would have expected patient 1's b/p to have been taken prior to the administration of hydralazine.
*He has had previous patients with prn high b/p medication orders in the past and once they stabilize their b/p will be lower then upon admission.
*As a point of practice he would rather be notified on a condition change instead of ordering a prn b/p medication to lower their b/p.
*He:
-Has high expectations and would have expected staff education to occur in the next couple of days after an incident occurred.
-Felt there was a possibility both of those med errors could occur again.
-Had attended all the medical staff meetings. The med errors had not been mentioned or reviewed at any of those meetings.

Interview on 1/26/21 at 1:08 p.m. with RN L revealed:
*She had been with the provider since November of 2020.
*The Pyxis machine:
-Has a notation for "Look Alike and Sound Alike" meds.
-Will note underdose if you scan three pills if the patient order is for four pills.
*She had extra training for med administration with nurse educator E during orientation.
*She stated the electronic medical record had an alert system that turned yellow for meds that had parameters.
*Examples of medications with parameters were insulin and blood pressure meds.
*Concerning patient 1:
-She had not helped him before and he was quite anxious that day.
-She went to the Pyxis and got Seroquel out for him.
-The other nurse on duty said the Seroquel was to be given at night and mentioned giving hydrolozone.
-She put the Seroquel back in the Pyxis and took out the hydralazine.
-Administered the hydralazine.
-The medical record had not flagged yellow to take the patient's b/p prior to administration.
-After she had entered the med as given in his MAR was when she realized she had given him the wrong med.
-Shortly after, he had turned his call light on.
-When she went into his room to check on him, he was unresponsive.
*She was not aware of any education for the entire staff concerning "Looks Alike Sounds Alike" meds.

Interview on 1/26/21 at 1:36 p.m. with nurse supervisor M revealed:
*She was the nurse supervisor at the time of patient 1's med administration error.
*Patient 1 was very anxious and was yelling out.
*RN L asked about giving him Seroquel.
*Nurse supervisor M:
-Told RN L patient 1 was on hydroxyzine and to give him that.
-Had not heard from RN L again until after the hydralazine had been administered.
-Looked at the MAR and realized the patient was on Midodrine for b/p support.
-Was called into the code for patient one.
*Patient 1 was talking to the staff prior to transferring to a higher-level of care facility.
*Nursing staff had been talked to about med administration but no random competency checks had occurred.
*She was aware:
-Patient 2 had received to much long-acting insulin and required close observation at a higher-level care facility.
-The nurse educator E had worked with LPN N on insulin administration.
*To her knowledge there had not been any formal education on med preparation/administration for insulin and b/p meds since those two events had occurred.
*She agreed:
-There should have been educated provided for all the nursing staff following those two incidents to ensure the risk of it occurring again was removed.
-That would have included competency checks on all the staff after the education had occurred.

Interview on 1/26/21 at 2:00 p.m. with LPN N revealed:
*She started employment with the provider in June 2020.
*The provider had:
-Put parameters in place for blood pressure meds.
-A standing orders for sliding scale insulin administration.
*Two staff members were required to be present when insulin was taken out of the Pyxis and prepared for administration.
-They were required to verify the insulin dose with the orders to make sure they matched.
*Concerning patient 2:
-She:
--Had misread the the patient's insulin order.
--Stated "My witness also misread the order."
--Had been rushed that day and misread the order as 40 units.
--Stated: "I kept seeing that order as 40 units all day and I'm not sure why."
-After she had administered the insulin she tried to enter 40 units into the system.
--The MAR displayed an error and she notified nurse supervisor O.
*After the insulin med error incident all the staff were required to:
-Watch a video on insulin administration.
-Have a competency check off.
-Review the high risk med policy.
--The training should have been completed within a week or two.
*No education had been given after patient 1's med administration error.

Interview on 1/26/21 at 3:59 p.m. with nurse supervisor O revealed:
*She was:
-Working on the night of the insulin med administration error.
-The second witness at the Pyxis.
*LPN N showed her the patient's blood sugar level and insulin order.
*The insulin order for patient 2 was four units of Detemir.
*She:
-Had to leave the room to respond to an emergency and did not see the insulin syringe.
-Stated: "I reiterated four units at least three times to her."
-Stated: "[LPN N's name] never once mentioned 40 units of insulin during the entire process."
*After LPN N notified her of the error she contacted the physician.
*Patient 2 was transferred to a higher-level of care facility for close observation because the insulin was long acting.
*She:
-Had received education on the computer and in the group huddles.
-Could not remember if there was a deadline for education completion.
*She:
-Had heard there was an E-mail sent out on education for "Look Alike Sound Alike" meds.
-Stated: "Many staff do not check their e-mails or rarely do, I know I don't."
-Not supported the idea of staff huddles and emails as a formal method for education.
-Would have expected some follow-up with staff due to the significance of those med errors.

Interview on 1/27/21 at 4:20 p.m. with medical director P revealed:
*Nursing was ultimately responsible for reviewing/investigating med administration errors.
*They should have determined if the med administration error was a system error or an individual error.
*He agreed:
-There was a chance of the sentinel events occurring again without the proper follow-up education for the staff.
-The education of all the staff needed to occur sooner to remove the risk of that incident occurring again.

Surveyor: 32355
5. Review of the provider's Nursing Department Staff Meetings from August 2020 through January 2021 revealed:
*On 8/24/20 and 8/25/20 the pharmacy services department reviewed the process for:
-Carbohydrate (CHO) counting with insulin administration and sliding scale insulin administration.
-Verifying insulin with the MAR/order along with the correct medication amount.
-Scanning the med prior to administering it to the patient.
*On 9/28/20 and 9/29/20:
-The dietician reviewed CHO counting again with a handout provided. A document was handed out for the staff to complete on CHO counting. That document was to be returned to the nurse educator by the end of October.
-The safety committee documented there was 20 med errors since opening of the facility in June. They were reminded to use time management at the start of the shift.
*The month of October was the only month that supported nursing competencies for:
-Follow-up with CHO handout from September.
-Watching the staff set-up and prepare for insulin administration.
-Those competencies had been a part of their annual review/education.
*There was no:
-Nursing department meetings for the month of December and January due to the resignation of their chief nursing officer (CNO).
-Supporting documentation that the med administration policy for LASA meds and insulin were reviewed after the significant med errors above had occurred.

Review of the Medication Errors Performance Improvement Group quarterly meeting minutes for 9/28/20 and 12/17/20 revealed:
*From 6/1/20 through 9/28/20 there had been 20 med errors.
*At the initial meeting on 9/28/20 the following was reviewed and discussed:
-A trend had been identified with meds not being given and incorrect dosing.
-Out of those 20 med errors only 2 nurses had received additional training on med administration.
-The CNO thought time management was an issue and she would continue to remind the staff to immediately review their patients upon checking in for their shift.
-The nurse educator was to have reviewed the provider's ACEIT program for education on their med administration bullet points. One topic a week was to be chosen and reviewed during the staff huddles (report), as well as for staff meetings.
*At the second meeting on 12/17/20 the following was reviewed:
-There had been an additional six more med errors since their last meeting.
-A trend in omission had been identified.
-No particular staff had been identified with re-occurring med errors so no additional training on med administration had been done.
-There was no follow-up regarding the ACEIT program weekly education the nursing staff were to have reviewed during their shift huddles.

Review of the provider's 3/17/20 Medication Administration policy revealed:
*Purpose: "To establish consistent guidelines to ensure that patient care and safety are maintained through proper medication administration."
*Responsibility: "Medical staff, pharmacy staff and all clinical staff who administers and/or handles medications will follow this policy as outlined below."
*Administration of Medication:
-"All medications will be administered after verifying the patient's identity utilizing two approved identifiers. Scanning does not take the place of two identifier verification."
-"Prior to administering medications: Confirm the "six rights" of medication administra

Based on observation, interview, medication/fluid event form review, root cause analysis event form review, job description review, and policy review, it was determined the provider failed to ensure one of one director of pharmacy services (DOP) (H) worked in collaboration and provided oversight with nursing services to identify trends, education, and competency needs for:
*Twenty-six medication (med) administration errors that occurred from 6/1/20 through 1/25/21.
-Two of those med errors were significant in nature and required the activation of the Emergency Medical System (EMS) with a transfer to a higher-level of care facility for close observation of their health status.
-One of those med errors resulted in a sentinel event after the patient expired two days post event.
*All nursing staff after one of one patient (1) who had been administered the wrong medication for the treatment of anxiety by one of one registered nurse (RN) (L).
*All nursing staff after one of one patient (2) who had been administered the incorrect dose of a long-acting insulin by one of one licensed practical nurse (LPN) (N).

These failures have the potential to lead to serious harm, injury, impairment, or death.

NOTICE:
On 1/27/21 at 11:16 a.m. Immediate Jeopardy was identified when the provider failed to implement nationally recognized standards for medication (med) administration. The chief executive officer (CEO) was presented the Immediate Jeopardy Template on 1/27/21 at 11:16 a.m.

PLAN:
The facility provided the following acceptable removal plan on 1/27/21 for pharmacy and nursing services:
*Description of At-Risk are of Non-compliance: "One patient received 40 units of insulin vs the required 4 units ordered for long acting insulin. This required a transfer to a higher level of care provider for close and one-on-one observation for 24 hours."
-Detailed Description of action taken: " Root Cause Analysis (RCA) completed on September 11, 2020. In addition to the actions taken from finding of RCA education on insulin will be provided to staff immediately of those who are working. All on-coming staff will receive education prior to start of shift. Training will be provided by both the Interim CNO (chief nursing officer) or designee and DOP or designee. Email education to all RNs and LPNs containing above education will be distributed on 1/27/2021."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Observation of signal dose of insulin administration will begin today, 1/27/21, with nurses. This observation will continue until 100% of all licensed nurses have been observed. Interim CNO and DOP will sign off on observation completed. All staff will be observed on their next scheduled shift. Observations will be completed 2/2/2021 or by end of next schedule shift by the interim CNO or designee and DOP or designee."
--"An attestation will be created for all RNs and LPNs to sign for confirmation of education."

*Description of At-Risk are of Non-compliance: "One patient received a prn (as needed) medication to lower blood pressure (b/p) instead of an anti-anxiety medication. The medications are classified as "look alike, sounds alike." Within 20 minutes of receiving this medication the patient coded requiring life sustaining measures and EMS notification for transfer to a higher level of care facility. Two days post event the patient expired."
-Detailed Description of action taken: "Education on look-alike sound-alike and proper use of PRN medications on orders as appearing on MAR (medication administration record) will be provided to RNs and LPNs immediately of those who are working. Email education to all RNs and LPNs containing above education will be distributed on 1/27/2021. Education on all on-coming RNs and LPNs will receive education prior to completion of their next scheduled shift. Training/inservice will be provided by both the CNO or designee and DOP or designee. An attestation will be created for all RNs and LPNs to sign for confirmation of education."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Interim CNO and DOP will sign off on look alike sound alike medication and proper use of PRN medications education as attested to by RNs and LPNs upon completion."

*Description of At-Risk are of Non-compliance: "Lack of pharmacy collaboration and oversight with nursing services for 26 medication administration errors from 6/1/20 thru (through) 12/17/20. This would include 2 significant medication administration errors. Both resulting in a transfer to a higher level of care. One resulting in death."
-Detailed Description of action taken: "Interim CNO or designee and DOP or designee will jointly review RL Solutions-Healthcare Risk Management Software (RL6) event reporting system for medication/fluid events to determine if any actions are needed to be taken. The Interim CNO and DOP will be required to sign-off on medication events starting January 27, 2021, moving forward."
-Anticipated Completion date: 2/2/2021.
-Individual Ultimately Responsible for Plan Implementation and Sustainability: CNO/DOP.
-Description of Evaluation Method. If via audits, include: "Sample size, Denominator description, Numerator description, To whom results will be reported."
--"Trends will be referred and reviewed in the Medication Error Performance Improvement Team, that will be meeting monthly, with results reported quarterly to P&T (Pharmacy & Therapeutics), MEC (Medical Staff), and to GB (Governing Board)."

The removal plan was reviewed and accepted by the surveyors on 1/27/21. The implementation of the plan was verified and their Immediate Jeopardy status was removed on 1/27/21 at 6:15 p.m.

Findings include:

1. On 8/22/20 patient 2 was administered 40 units of a long-acting insulin versus the required 4 units per physician orders. He was transferred to a higher-level of care facility for close and one-on-one observation.

2. On 1/10/21 patient 1 was administered a med that lowered blood pressures instead of an anti-anxiety med.
*Both of those meds had been classified as LASA (Looks Alike Sounds Alike) meds.
*Within 20 minutes of receiving that med the patient coded and required life sustaining measures.
*The EMS was activated and he was transferred to a higher-level of care facility.
-Two days post event the patient expired.

3. Both of the above events required immediate investigation and initiation of a Root Cause analysis (RCA) per their Sentinel Events policy.
*The Sentinel Events required follow-up and staff education to the ensure the risk of that occurring again had been removed.
*After interviews and document reviews, the immediacy of the situations had not been either recognized or removed.
*Education and corrective action was provided only for those individuals who had administered the meds incorrectly.
*The pharmacy services, nursing services, nurse educator, and the quality risk director had not worked together to ensure:
-All nursing staff had immediate follow-up and training to ensure the nationally recognized standards for med administration were implemented and followed.
-All nursing staff had immediate follow-up with additional training and education on the facility med administration policy.
-Competencies on med administration were completed for all the nursing staff to ensure the risk of those events happening again had been removed.
*All nurse education for insulin administration had been set-up but was not required to be completed until 9/30/20.
-That had been 39 days post event.
*No staff education and med administration competency review had been set-up for the incident that occurred on 1/10/21.
-The management team, including their regional office, indicated and stated that was an isolated event and no further education for the rest of the nursing staff was required to ensure the risk of that occurring again had been removed.
*Interview on 1/27/21 with a certified nurse practitioner (CNP) and medical doctor (MD) agreed the potential for reoccurrence of these Sentinel Events was still present.
-They would have expected education for all the staff to have occurred as soon as possible after both of those
events.

Review of the Pharmacy and Therapeutics Committee meeting minutes from 6/1/20 through 1/25/21 revealed:
*The meetings were held quarterly and involved the medical director, pharmacy services, nursing services, and the CEO.
*There had been two meetings since the opening of the facility on 6/1/20.
-Those meetings were held in September 2020 and December 2020.
*In those meetings they reviewed how many medication/fluid events had occurred for each month.
*The December meeting was the only meeting that supported a trend in types of med errors.
-The trends identified had been omission of meds and/or the patients received extra doses of a med.
*There was no documented discussion from either of the meetings regarding:
-The significant med error that occurred on 8/22/20 when a patient received 36 extra units of a long-acting insulin.
-The results of or implementation of the required training, education, and competency reviews for all the nursing staff to ensure the risk for the reoccurrence of that med error was removed.
-Required policy and procedure reviews to ensure their process for insulin administration had supported nationally recognized standards for med administration.




18559

4. Interview on 1/26/21 at 4:28 p.m. with pharmacist H revealed:
*She would have received software alerts for any medication or fluid administration error.
*If the error was performed by the nursing staff the chief nursing officer would have handled the follow up.
*Any errors that had involved the pharmacy staff or Pyxis were handled by the pharmacist.
*She confirmed the following medication administration errors:
-July had three errors.
-August had eight errors.
-September had eight errors.
-October had one error.
-November had two errors.
*The earlier errors had been caused by documentation errors with fluids due to the staff learning a new computer system.
*There had been extensive training on med documentation with nurse educator E.
*She had provided Pyxis training for the nursing staff on August 24th and 25th, 2020.
*Nothing had changed on the pharmacy side for insulin administration and preparation.
*Insulin vials have been marked as high alert meds in the Pyxis.
*A list of high alert meds had been posted in the medication room for the nurses.
*She had performed random observations of medication administration, but those observations were not documented to support they had occurred.
*The education for patient 1's medication administration would have been handled on the nursing side.
*The final evaluation of the incident would have been performed by the CNO and medication error committee.
*She had reiterated at nursing huddles what a medication was for, but again had not documented it to support education had occurred.
*The medical record system does not have a hard stop to check parameters of a medication.
*She can put in a recommendation for education and changing the high alert notifications in the Pyxis system.
-Those recommendations had to be approved by corporate prior to making changes or entering them.
*She had just started looking at hard stops after the incident and med error that occurred with patient one.
*She agreed as of now there was still a risk for the same medication administration error to occur again.

Interview on 1/26/21 at 5:45 p.m. with the regional chief nursing officer (RCNO) F revealed the provider had no policy or procedure specifically to insulin administration.
*He stated:
-"The procedure and everything for the staff to follow is out there in the Pyxis and on the physician's order for the staff to follow."
-"This medication - high alert policy covers insulin administration and processes."
-"There is no further policy."

Interview on 1/27/21 at 9:35 a.m. with RCNO F and regional quality risk officer G revealed:
*The pharmacist and the CNO should have worked together when investigating med errors.
*The pharmacist is responsible for all medication from the time the it had entered the facility until the medication leaves the facility.
*They agreed the process would have improved with the incorporation if the pharmacy services into the education portion of the med administration error.
*From the time of dispensing the medication the burden falls on nursing but pharmacy does have input.
*RCNO F stated: "Even though the med error that happened with [patient 1's name] was unfortunate, I do not believe education and competencies had to be done for everyone. I see this as an isolated incident and the risk of it happening again is low."

Surveyor: 32355
5. Review of the provider's 5/18/20 Medication-High Alert policy revealed:
*Purpose: "To maintain the safe use of medications that pose a high risk for error and a high risk of injury to patients."
*Policy: "The hospital will maintain a policy to identify high-alert (risk) medications based on evaluation of usage patterns, national data on medication use, medication errors and adverse drug events and develop strategies to mitigate errors with these medications."
*The policy further identified how the pharmacy department would have identified high risk med alerts in the Pyxis and medication administration record for the staff.
*There:
-Would have been double checks required when administering high-alert medications as necessary.
-Was no documentation or procedure specific to the preparation and administration of insulin per the staff interviews.

Review of the provider's 3/17/20 Medication - Event Reporting policy revealed:
*Purpose:
*"When a potential or actual medication event occurs, a specific procedure will be followed to ensure the safety of the patient and provide accurate documentation of the occurrence."
*"The procedures for reporting a medication event and the mechanism for multi-disciplinary review to allow appropriate follow-up and implementation of change to prevent future medication events are outlined."
*Responsibility:
-"It is the responsibility of the Chief Nursing Officer and the Director of Pharmacy to disseminate the information regarding the medication error policy."
-"Clinicians and medical staff are responsible for reporting errors found in the medication management process."
*"The Chief Nursing Officer and Director of Pharmacy and/or designees will review the Event Report to identify potential causative factors for the medication event."

Review of the provider's 5/18/20 Medication - Look Alike Sound Alike policy revealed:
*Purpose: "To develop and maintain systems to prevent confusion among look-alike and sound-alike medications."
*Responsibility:
-"The Medical Executive Committee, along with Pharmacy and Therapeutics committee will be responsible for determining a list of Look Alike Sound Alike (LASA) medications."
*"The Director of Pharmacy will be responsible for disseminating information regarding the LASA list and policy and ensuring overall compliance."
*Policy: "As medications are reviewed by the Pharmacy & Therapeutics Committee for addition to the formulary, potential of look-alike and sound-alike errors will be included in the evaluation."

Review of the provider's unsigned and undated Pharmacy Director job description revealed:
*"The Pharmacy Director supports and conveys the hospital and organization's mission to all staff, holds staff accountable for performance, motivates and develops staff to improve performance and is an effective leader."
*"The Pharmacy Director maintains relationships with the Chief Nursing Officer, Director of Case Management, Director of Marketing, Director of HR, Director of Quality, Controller, and Medical Director to ensure that patient, staff, and the hospital needs are met."
*"The Pharmacy Director is responsible for the overall departmental operations, including conducting continuous assessment and implementation of process improvements that will enhance the pharmacy department's performance, and providing direct patient and pharmaceutical care."
*"Implements and communicates policies and procedures, and holds staff accountable to their roles and responsibilities."
*"Provides staff and hospital education regarding pharmaceutical care and medication management."
*"Supports corporate compliance programs and reports questionable situations, concerns, and complaints immediately."
*"Creates opportunities to promote superior patient satisfaction and outcomes."
*"Demonstrates commitment to improve quality and safety through training, education, communication, collaboration, innovation, and execution."
*"Considers patient and staff safety, takes initiative to identify and eliminate risks, and educates patients, families, and team in those strategies."
*"Collaborates with others to coordinate care, resolve concerns/complaints, and address the needs of patients, families, staff and physicians in a timely manner."

Refer to A385.