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Based on facility policy review, medical record review, and interview, the Governing Body failed to ensure contracted anesthesia services were provided in a safe and effective manner for 1 patient (Patient #1) of 3 patients reviewed for surgical services.

The findings include:

Patient #1 was admitted to the facility on 12/14/2022 for Nonrheumatic Aortic Valve Disease with a Transcatheter Aortic Valve Replacement (TAVR) surgical procedure scheduled. Patient #1 listed multiple drug allergies which included Cephalosporins. Despite allergies being reviewed and verified with Patient #1 in the pre-operative (Pre-op) setting by employed staff and contracted anesthesia services, Patient #1 received a single dose of Ancef (an antibiotic used to treat or prevent bacterial infections- drug class-Cephalosporins) intravenous (IV) push in the Operating Room (OR) prior to the time out and induction of the surgical procedure. The Interventionalist Cardiologist verified the allergy of Cephalosporins prior to the surgical procedure and had ordered an alternate class of antibiotics to be administered to Patient #1. The alternate antibiotics ordered were retrieved from the medication dispensing system and placed at Patient #1's bedside for the CRNA (Certified Registered Nurse Anesthetist) to administer in the OR suite. The CRNA reviewed the allergies with Patient #1. The CRNA then reported to the Surgeon that Patient #1 had an allergy to Penicillin instead of Cephalosporin and asked if Ancef would be acceptable to administer. The CRNA then proceeded to retrieve the Ancef from the medication dispensing system and administered the antibiotic to Patient #1 (with no immediate anaphylactic reaction noted). The Surgeon identified the wrong antibiotic had been administered to Patient #1, despite review of allergies by multiple staff members and discussed the issue with the CRNA, who administered the wrong medication on 12/14/2022. The CRNA immediately notified his supervisor the Anesthesiologist by telephone. The contracted anesthesia services failed to report the medication error in the IRIS (Incident Reporting Information System) or to the facility timely. The facility was made aware of the medication error on 1/17/2023 (35 days later), when Patient #1 had a follow-up visit in a clinic after the surgical procedure and informed the NP (nurse practitioner) what had happened. The NP notified the Pharmacy Department, and the incident was entered into the IRIS system. The investigation was initiated and discovered this was an anesthesia (contracted service) issue and was forwarded to the anesthesia's quality department. A complete and thorough investigation with action plans for the medication error was not given to the facility.

Refer to A-0084

Based on facility policy review, medical record review, and interview the facility failed to ensure the anesthesia group (a contracted service) provided services in a safe and effective manner, and failed to report, investigate, and develop an action plan for a medication error timely, for 1 patient (Patient #1) of 3 surgical patients reviewed.

The findings include:

Review of the facility policy titled, "Incident Reporting Information System (IRIS), Occurrence Reports," dated 3/2021, showed "...The associate involved in, observing, or discovering the occurrence is responsible for completing the IRIS system in a timely manner..."

Review of the facility policy titled, "Medication Administration & Monitoring," dated 2/2022, showed "...Before dispensing...reviews the appropriateness of all medication orders to be dispensed...All medication orders are reviewed for...Existing or potential interactions...Patient allergies or potential sensitivities...After the medication order has been reviewed, all concerns, issues, or questions are clarified with the...prescriber before dispensing...Any questions or concerns regarding medication orders are strongly encouraged to be brought to the attention of the prescribing practitioner prior to medication administration...All warning and error messages must be fully investigated prior to proceeding with medication administration...Give the prescribed medication using the six rights: Right patient, Right medication, Right dose, Right route, Right time, Right documentation...Report any medication administration error, adverse drug reaction, or medication incompatibility: Immediately notify prescribing physician...Notify Pharmacy...Document details in patient's medical record...Complete IRIS report..."

Patient #1 was admitted to the facility on 12/14/2022 for Nonrheumatic Aortic Valve Disease with a Transcatheter Aortic Valve Replacement (TAVR) surgical procedure scheduled.

Review of a Return Office Visit Consultation note dated 12/1/2022, showed Patient #1 had a past medical history of Coronary Artery Disease, Hypertension, Obesity, and Non-Rheumatic Aortic Stenosis. Patient #1 had several allergies listed which included Cephalosporins (antibiotics used to treat bacterial infections).

Review of the Physician Orders dated 12/14/2022 at 6:16 AM, showed Patient #1 was ordered gentamicin 320 mg (milligrams) IVPB (intravenous piggyback) and vancomycin 1,000 mg IVPB through the Surgical Prophylaxis order set. The gentamicin and vancomycin were not administered and were discontinued on 12/14/2022 at 10:44 AM.

Review of the Anesthesia Record dated 12/14/2022, showed Patient #1's allergies reflected Cephalosporins (includes first generation drugs such as Cefazolin and Cephalexin).

Review of the Perioperative Medication Administration dated 12/14/2022 at 8:35 AM, showed Patient #1 received Cefazolin (Ancef) 2 gram IV. The medication was administered by the CRNA (certified registered nurse anesthetist).

Review of a Nursing Progress Note dated 12/15/2022 at 1:30 PM, showed Patient #1 was discharged with no needs noted.

Review of a Family Practice note dated 12/21/2022, showed Patient #1 was seen at her PCP (primary care physician) 1 week s/p (status post) TAVR procedure. She presented with fatigue and shortness of breath. "...She did experience an adverse reaction to Ancef as she is allergic to the penicillins but was given the medication anyway. She experienced hives and a rash that is still present a week later. Fine red rash on her back with hives on her upper extremities and thighs...She has mild pedal edema present bilaterally..." Physical examination showed respiratory effort unlabored, nonpitting edema, mild bilateral pedal edema, erythema, fine rash on back with hives on upper extremities and thighs.

Review of a Family Practice note dated 12/28/2022, showed "...status post transcatheter aortic valve replacement...procedure went fairly well... they did give patient 1 dose of Ancef...she is allergic to cephalosporins...She did have a delayed hypersensitivity reaction and had angioedema throughout most of her body. This responded to antihistamines..." Physical examination showed "Right greater than left peripheral edema...Skin: normal tone..."

Review of a Summarization of episode note dated 1/17/2023, showed Patient #1 returned to the Valve Clinic for a post discharge follow-up echocardiogram. The Nurse Practitioner (NP) wrote, "...Of note, she was given Ancef 2 g IV...at the time of her TAVR, despite documented allergy, and developed delayed generalized angioedema [swelling under the skin] with anasarca [general swelling throughout the body] which persisted for approximately 2 weeks postprocedure, treated by her primary care physician. She continues to have some lower extremity edema, which had declined over the past several weeks...Her lower extremities have trace to 1+ edema to her knees with associated rubor [body tissue irritation characterized by pain, swelling, redness, and heat]..."

Review of the Event Communication/Discussion summary undated, showed the 1st notification of the event was entered into IRIS on 1/17/2023. The Surveyor questioned who reported the incident and how did the facility find out. It was reported to the Surveyor by the Accreditation Manager that the NP reported the incident to a pharmacist and the pharmacist entered the event into the IRIS system.

Review of the IRIS Summary dated 1/17/2023, showed Patient #1 received Ancef by CRNA as a pre-operative when she had a listed allergy to Cephalosporins-Anaphylaxis. The patient had a delayed alleged angioedema reaction. PreOp Follow up from the Manager showed after pulling the Pyxis (automated medication dispensing system) report for Patient #1 for 12/14/2022 showed the Pre-op nurse retrieved the correct antibiotics (gentamycin and vancomycin) and had them at the bedside ready for anesthesia. The CRNA pulled the Ancef in the OR and administered the Ancef instead of the gentamycin and vancomycin as previously ordered. The Manager spoke with the Anesthesiologist who stated he was aware of the incident on 12/14/2022. The Manager and the Anesthesiologist discussed time outs and covering allergies during timeouts. The Anesthesiologist stated he had addressed the incident with the CRNA. Pharmacy Follow-up from the Pharmacy Manager showed "...CRNAs and Anesthesiologists pull medications from non-profiled machines so even if pharmacists had verified the orders ahead of time there would not be an opportunity for an action made by a pharmacist to have an effect on this scenario...This situation...is an outlier..." The summary showed the incident had been discussed with pre-testing nurses to potentially implement a process to perform a scripted allergy interview and document in the electronic medical record which would still require the CRNA to look at the allergy list. Quality was informed.

Review of a Summarization of episode note dated 2/8/2023, showed Patient #1 returned for a follow up appointment with Cardiologist status post TAVR procedure on 12/14/2022. "...She has lower extremity edema, which is stable. This occurred after receiving cephalosporin antibiotic in the hospital. She did have a rash after the cephalosporin, which occurred in a delayed fashion. She developed lower extremity edema, which is improving but still persists..."

During a telephone interview on 6/6/2023 at 10:35 AM, the Anesthesiologist stated he had been made aware Ancef was administered to Patient #1 despite her documented allergy to Cephalosporins. The pre-procedure assessment was to ask and verify allergies with severity of reactions. The CRNA was the one who verified the allergies, he was unsure of what happened and why Patient #1 received Ancef, after the verification of the allergy to Cephalosporins. He stated there were standard order sets for surgeries with approved antibiotics on the order sets. If a patient has an allergy to the antibiotic approved for the surgery, then an alternative was available. Patient #1 had no ill effects during hospital stay after she received the Ancef. Patient #1 had no issues with breathing, was not intubated, and only received IV (intravenous- a way of delivering medications into a vein) sedation for procedure. He was made aware after the patient was discharged from the hospital that issues had developed days later after going home.

During an interview on 6/6/2023 at 12:27 PM, Pharmacist #1 stated while briefly reviewing the case he had seen an order for Vancomycin and was unsure why the Ancef was pulled. He stated charts were flagged upon admission once the allergies was listed and verified. In the electronic chart the severe allergies are highlighted in orange. He stated a medication error was reported in the reporting system by whomever finds the error. A safety committee meets to discuss and investigate the error and the department managers usually handle the errors and the reporting.

On 6/6/2023 at 11:34 AM, Surveyor requested the process for monitoring medication errors, reporting out, committees, and follow-ups. A typed summary titled "Process for monitoring medication errors-reporting out, committees, follow-up, etc" was provided to the Surveyor which showed medication errors are reported in IRIS. Each IRIS was reviewed from an interdisciplinary perspective and assigned to the department's Primary Reviewer to be investigated. The summary showed any pertinent information from medication errors was shared with pharmacy staff for awareness in the Pharmacy Safety Huddle. The summary also showed IRIS trends were shared in various committees including Safety Huddle, Medication Safety Committee, Clinical Operations Council, Nurse Manager Meeting, and Quality Safety Committee.

During a telephone interview on 6/6/2023 at 3:30 PM, the CRNA stated he was able to recall the event with Patient #1 on 12/14/2022. He stated the daughter of Patient #1 was present in pre-op and allergies were verified with Patient #1. He stated he did pull the Ancef from the medication dispensing system after he discussed with the Surgeon that Patient #1 did have an allergy to Penicillin (instead of Cephalosporin allergy) and asked if Ancef was okay to administer. The CRNA stated Patient #1 had several allergies and these were discussed with the surgeon and the cardiologist prior to the administration of the Ancef. The Surgeon reviewed the case and noticed Patient #1 had been administered Ancef with a Cephalosporin allergy listed. The CRNA stated the Surgeon discussed the case with him in person. The CRNA stated he presented the allergy to the Surgeon as a Penicillin allergy instead of a Cephalosporin allergy. He stated the patient was monitored throughout the entire stay with no ill or quantitative effects. The patient did not require intubation, the surgical case did not have to postponed, and hospitalization was not prolonged. He stated he followed up with the patient the following day by speaking with the nurse as the patient was still sleeping, with no issues or complaints. He further stated he was made aware sometime after discharge, the patient had a delayed trunk rash and swelling. He stated the Anesthesiologist, his immediate supervisor had a face to face discussion with him, an action plan was formulated to discuss the hierarchy of antibiotics with the classes and cross classes and to review all medications and not certain medications.

During an interview on 6/7/2023 at 10:30 AM, the Accreditation Manager stated based on the facility's policy medication errors were be reported and entered in the IRIS reporting system immediately upon discovery of occurrence.

During a second telephone interview on 6/7/2023 at 11:44 AM, the CRNA clarified he presented the allergy information to the Surgeon as a penicillin allergy instead of a cephalosporin allergy. The Surgeon reviewed the case in the OR suite within minutes after the Ancef was pushed and prior to the first incision, that was when he (the Surgeon) questioned the Ancef administered. The CRNA stated they discussed what had happened and Patient #1 was monitored. The CRNA stated he immediately notified the Anesthesiologist, his immediate supervisor of the medication error. He stated he did not have access to the IRIS system and did not think about reporting to anyone else. He stated he followed his chain of command and reported to his immediate supervisor. He further stated the Surgeon and Interventionalist Cardiologist were present in the room and were aware of the error which occurred as well.

During a second telephone interview on 6/7/2023 at 11:56 AM, the Anesthesiologist clarified the anesthesia department does not use the IRIS system at the hospital. They typically will call their own Quality hotline to report and events or errors. He stated he did not report this event to the Quality hotline as the patient did not have an adverse outcome. This patient did not require any further interventions other than to be monitored, and did not require an extended stay in the hospital due to the error. He stated he later found out that she had a delayed reaction after she was discharged through one of her follow up visits.

During an interview on 6/7/2023 at 12:01 PM, the Risk Manager stated it was her expectation medication errors were to be reported or entered by someone in the OR department even if there was no reaction. She stated a medication was administered with a known allergy to the patient and that should have been reported through the reporting system. She stated the hospital gets IRIS reports from the OR all the time. She stated once the hospital was made aware an investigation was started. It was then determined this was an anesthesia issue and it was turned over to their quality department for further investigation. She stated the hospital got very little feedback from the anesthesia quality department regarding Patient #1's incident which occurred on 12/14/2022.

Based on facility policy review, medical record review, and interview the facility failed to ensure a Certified Registered Nurse Anesthetist (CRNA) (contracted service) followed a physician's order or order set resulting in a medication error when the CRNA administered a medication to a patient with a known drug allergy for 1 patient (Patient #1) of 3 patients reviewed for drug administration.

The findings include:

Patient #1 was admitted to the facility on 12/14/2022 for Nonrheumatic Aortic Valve Disease with a Transcatheter Aortic Valve Replacement (TAVR) surgical procedure scheduled. Patient #1 listed multiple drug allergies which included Cephalosporins. The patient's allergies were reviewed and verified with Patient #1 in the pre-operative (Pre-op) setting by employed staff and contracted anesthesia services. Patient #1 received a single dose of Ancef (an antibiotic used to treat or prevent bacterial infections- drug class-Cephalosporins) intravenous (IV) push in the Operating Room (OR) prior to the time out and induction of the surgical procedure. The Interventionalist Cardiologist had verified the allergy prior to the surgical procedure and had ordered an alternate class of antibiotics to be administered to Patient #1 due to allergies. The alternate antibiotics ordered were retrieved from the medication dispensing system and placed at Patient #1's bedside for the CRNA (Certified Registered Nurse Anesthetist) to administer in the OR suite. The CRNA reviewed the allergies with Patient #1. The CRNA then reported to the Surgeon that Patient #1 had an allergy to Penicillin instead of Cephalosporin and asked if Ancef would be acceptable to administer. The CRNA retrieved the Ancef from the medication dispensing system and administered the antibiotic to Patient #1 (with no immediate anaphylactic reaction noted). The Surgeon identified the wrong antibiotic had been administered to Patient #1, despite review of allergies by multiple staff members and discussed the issue with the CRNA, who administered the wrong medication.

Refer to A-0405

Based on review of facility policy, medical record review, and interview the facility failed ensure a patient with known drug allergy was given the right medication by a CRNA which resulted in a medication error for 1 patient (Patient #1) of 3 patients reviewed for safe drug administration.



The findings include:

Review of the facility policy titled, "Medication Administration & Monitoring," dated 2/2022, showed "...Before dispensing...reviews the appropriateness of all medication orders to be dispensed...All medication orders are reviewed for...Existing or potential interactions...Patient allergies or potential sensitivities...After the medication order has been reviewed, all concerns, issues, or questions are clarified with the...prescriber before dispensing...Any questions or concerns regarding medication orders are strongly encouraged to be brought to the attention of the prescribing practitioner prior to medication administration...All warning and error messages must be fully investigated prior to proceeding with medication administration...Give the prescribed medication using the six rights: Right patient, Right medication, Right dose, Right route, Right time, Right documentation...Report any medication administration error, adverse drug reaction, or medication incompatibility: Immediately notify prescribing physician...Notify Pharmacy...Document details in patient's medical record...Complete IRIS report..."

Patient #1 was admitted to the facility on 12/14/2022 for Nonrheumatic Aortic Valve Disease with a Transcatheter Aortic Valve Replacement (TAVR) surgical procedure scheduled.

Review of a Return Office Visit Consultation note dated 12/1/2022, showed Patient #1 had a past medical history of Coronary Artery Disease, Hypertension, Obesity, and Non-Rheumatic Aortic Stenosis. Patient #1 had several allergies listed which included Cephalosporins (antibiotics used to treat bacterial infections).

Review of the Physician Orders dated 12/14/2022 at 6:16 AM, showed Patient #1 was ordered gentamicin 320 mg (milligrams) IVPB (intravenous piggyback) and vancomycin 1,000 mg IVPB through the Surgical Prophylaxis order set. The gentamicin and vancomycin were not administered and were discontinued on 12/14/2022 at 10:44 AM.

Review of the Anesthesia Record dated 12/14/2022, showed Patient #1's allergies reflected Cephalosporins (includes first generation drugs such as Cefazolin and Cephalexin).
.

Review of the Perioperative Medication Administration dated 12/14/2022 at 8:35 AM, showed Patient #1 received Cefazolin (Ancef) 2 gram IV. The medication was administered by the CRNA (certified registered nurse anesthetist).

Review of a Nursing Progress Note dated 12/15/2022 at 1:30 PM, showed Patient #1 was discharged with no needs noted.

Review of a Family Practice note dated 12/21/2022, showed Patient #1 was seen at her PCP (primary care physician) 1 week s/p (status post) TAVR procedure. She presented with fatigue and shortness of breath. "...She did experience an adverse reaction to Ancef as she is allergic to the penicillins but was given the medication anyway. She experienced hives and a rash that is still present a week later. Fine red rash on her back with hives on her upper extremities and thighs...She has mild pedal edema present bilaterally..." Physical examination showed respiratory effort unlabored, nonpitting edema, mild bilateral pedal edema, erythema, fine rash on back with hives on upper extremities and thighs.

Review of a Family Practice note dated 12/28/2022, showed "...status post transcatheter aortic valve replacement...procedure went fairly well... they did give patient 1 dose of Ancef...she is allergic to cephalosporins...She did have a delayed hypersensitivity reaction and had angioedema throughout most of her body. This responded to antihistamines..." Physical examination showed "Right greater than left peripheral edema...Skin: normal tone..."

Review of a Summarization of episode note dated 1/17/2023, showed Patient #1 returned to the Valve Clinic for a post discharge follow-up echocardiogram. The Nurse Practitioner (NP) wrote, "...Of note, she was given Ancef 2 g IV...at the time of her TAVR, despite documented allergy, and developed delayed generalized angioedema [swelling under the skin] with anasarca [general swelling throughout the body] which persisted for approximately 2 weeks postprocedure, treated by her primary care physician. She continues to have some lower extremity edema, which had declined over the past several weeks...Her lower extremities have trace to 1+ edema to her knees with associated rubor [body tissue irritation characterized by pain, swelling, redness, and heat]..."

Review of the IRIS Summary dated 1/17/2023, showed Patient #1 received Ancef by CRNA as a pre-operative when she had a listed allergy to Cephalosporins-Anaphylaxis. The patient had a delayed alleged angioedema reaction. PreOp Follow up from the Manager showed after pulling the Pyxis report for Patient #1 for 12/14/2022 showed the Pre-op nurse retrieved the correct antibiotics (gentamycin and vancomycin) and had them at the bedside ready for anesthesia. The CRNA pulled the Ancef in the OR and administered the Ancef instead of the gentamycin and vancomycin as previously ordered. The Manager spoke with the Anesthesiologist who stated he was aware of the incident. The Manager and the Anesthesiologist discussed time outs and covering allergies during timeouts. The Anesthesiologist stated he had addressed the incident with the CRNA. Pharmacy Follow-up from the Pharmacy Manager showed "...CRNAs and Anesthesiologists pull medications from non-profiled machines so even if pharmacists had verified the orders ahead of time there would not be an opportunity for an action made by a pharmacist to have an effect on this scenario...This situation...is an outlier..." Quality was informed..."

Review of a Summarization of episode note dated 2/8/2023, showed Patient #1 returned for a follow up appointment with Cardiologist status post TAVR procedure on 12/14/2022. "...She has lower extremity edema, which is stable. This occurred after receiving cephalosporin antibiotic in the hospital. She did have a rash after the cephalosporin, which occurred in a delayed fashion. She developed lower extremity edema, which is improving but still persists..."

During a telephone interview on 6/6/2023 at 10:35 AM, the Anesthesiologist stated he had been made aware Ancef was administered to Patient #1 despite her documented allergy to Cephalosporins. The pre-procedure assessment is to ask and verify allergies with severity of reactions. The CRNA was the one who verified the allergies, he is unsure of what happened and why Patient #1 received Ancef, after the verification of the allergy to Cephalosporins. He stated there are standard order sets for surgeries with approved antibiotics on the order sets. If a patient has an allergy to the antibiotic approved for the surgery, then an alternative is available.

During an interview on 6/6/2023 at 12:27 PM, Pharmacist #1 stated while briefly reviewing the case he seen an order for Vancomycin and was unsure why the Ancef was pulled. He stated charts were flagged upon admission once the allergies are listed and verified. He stated in the electronic chart the severe allergies are highlighted in orange.

During a telephone interview on 6/6/2023 at 3:30 PM, the CRNA stated he was able to recall the event with Patient #1 on 12/14/2022. He stated the daughter of Patient #1 was present in pre-op and allergies were verified with Patient #1. He stated he did pull the Ancef from the medication dispensing system after he discussed with the Surgeon that Patient #1 did have an allergy to Penicillin and asked if Ancef was okay to administer. The CRNA stated Patient #1 had several allergies and these were discussed with the surgeon and the cardiologist prior to the administration of the Ancef. The Surgeon reviewed the case and noticed Patient #1 had been administered Ancef with a Cephalosporin allergy listed. The CRNA stated the Surgeon discussed the case with him in person. The CRNA stated he presented the allergy to the Surgeon as a Penicillin allergy instead of a Cephalosporin allergy. He stated the patient was monitored throughout the entire stay with no ill or quantitative effects. The patient did not require intubation, the surgical case did not have to postponed, and hospitalization was not prolonged. He stated he followed up with the patient the following day by speaking with the nurse as the patient was still sleeping, with no issues or complaints. He further stated he was made aware sometime after discharge, the patient had a delayed trunk rash and swelling.

During a second telephone interview on 6/7/2023 at 11:44 AM, the CRNA clarified he presented the allergy information to the Surgeon as a penicillin allergy instead of a cephalosporin allergy. The Surgeon reviewed the case in the OR suite within minutes after the Ancef was pushed and prior to the first incision, that is when he (the Surgeon) questioned the Ancef administered. The CRNA stated they discussed what had happened and Patient #1 was monitored. The CRNA stated he immediately notified the Anesthesiologist, his immediate supervisor of the medication error. He stated he did not have access to the IRIS system and did not think about reporting to anyone else. He stated he followed his chain of command and reported to his immediate supervisor. He further stated the Surgeon and Interventionalist Cardiologist were present in the room and were aware of the error as well.

During a second telephone interview on 6/7/2023 at 11:56 AM, the Anesthesiologist clarified the anesthesia department does not use the IRIS system at the hospital. They typically will call their own Quality hotline to report and events or errors. He stated he did not report this event to the Quality hotline as the patient did not have an adverse outcome. This patient did not require any further interventions other than to be monitored, did not require an extended stay in the hospital due to the error. He stated he later found out that she had a delayed reaction after she was discharged through one of her follow up visits.

During an interview on 6/7/2023 at 12:01 PM, the Risk Manager stated it was her expectation that medication errors to be reported or entered by someone in the OR department even if there was no reaction. A medication was administered with a known allergy to the patient and that should have been reported through the reporting system. She stated once the hospital was made aware of the medication error (35 days later) an investigation was started. It was then determined this was and anesthesia issue and it was turned over to their quality department for further investigation. She stated the hospital got very little feedback from the anesthesia quality department.