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Based on interview, clinical record review, and document review, the facility's governing body failed to ensure a contracted Certified Registered Nurse Anesthetist (CRNA) received training to provide services in a safe manner resulting in a significant and lethal medication error.

Findings include:

The contracted CRNA had a start date with the facility of 06/06/22.

An email chain regarding the CRNA's training, documented the Provider Liaison had spoken with the CRNA and the CRNA was proficient in the use of the Pyxis (an automated medication dispensing system) on 06/03/22. The response from the pharmacy representative on 06/06/22, was the CRNA was good to go.

A Pyxis Med station Assignment form for the CRNA, dated 06/03/22, was signed by the CRNA but lacked signatures from a manager or pharmacist.

An undated statement from the CRNA regarding a medication error in the Operating Room (OR) on 12/19/22, documented the CRNA had begun preparation for the cesarean section procedure in OR six by pulling the drugs needed from the Pyxis. The CRNA pulled what the CRNA thought to be bupivacaine from the second drawer. The CRNA pulled a vial, verified the date, and placed the vial on top of the pyxis with the other medications (fentanyl and morphine). The CRNA labeled a syringe for the bupivacaine, verified the date again, drew up the medication, and placed the vial on top of the Pyxis. The CRNA then verified the date a third time prior to throwing the vial in the sharp's container. Once the patient entered the room, the CRNA prepped the patient and accessed the intrathecal space on the first attempt. The medications were then administered intrathecally.

A note from the Director of Corporate Responsibility and Enterprise Risk, dated 12/19/22, documented the CRNA reported the CRNA had been unfamiliar with OR six. The patient was given a medication via the spinal route and the medication was thought to be bupivacaine pulled from the Pyxis. The medication was not effective. The patient started having symptoms in recovery causing the CRNA to question what was given in the OR. The CRNA stated the Digoxin should not have been in the Pyxis and was not in the Pyxis in the OR in labor and delivery.

On 01/11/23 at 4:10 PM, the Regulatory and Accreditation Specialist verbalized the facility did not know if the CRNA was proficient in Pyxis, but the CRNA had stated the CRNA did not need the training. The Pyxis training was the responsibility of the pharmacist and the CRNA received Pyxis access even though the CRNA had not received training from the pharmacist and did not demonstrate competency for the pharmacist.

The Bylaws of the facility, last revised 03/24/21, documented the Board would oversee the quality of care provided by the Hospital on matters relating to professional competency.

The Medical Bylaws of the facility, Board approved 05/2022, documented each CRNA allied health professional staff member would be obligated to retain appropriate responsibility within the CRNA's area of professional competence for the care and supervision of each patient in the Hospital for whom the CRNA was providing services and participate in pertinent continuing education.

Based on interview, clinical record review, and document review the facility failed to ensure an order was obtained from a practitioner prior to or immediately after application of restraints for 2 of 12 patient's reviewed for compliance with restraint practices (Patients #7 and #12).

Findings include:

Patient #7

Patient #7 was admitted to the facility on 12/27/22, with diagnoses including colon cancer, acute hypoxic respiratory failure, and cardiogenic shock.

The restraint summary flowsheet for Patient #7, documented restraints were initiated on 12/27/22 at 5:00 PM.

The Non-Violent Restraints Order for Patient #7 was dated 12/28/22 at 9:00 AM.

The restraint summary flowsheet for Patient #7, documented restraints were initiated on 01/01/23 at 1:00 PM.

The Non-Violent Restraints Order for Patient #7 was dated 01/01/23 at 9:01 PM.

Patient #12

Patient #12 was admitted to the facility on 01/01/23, with diagnoses including septic shock, atrial fibrillation with rapid ventricular rate, and hepatitis.

The restraint summary flowsheet for Patient #12, documented restraints were initiated on 01/02/23 at 12:00 AM.

The Non-Violent Restraint Order for Patient #12 was dated 01/02/23 at 1:24 AM.

On 01/11/23 at 11:35 AM, the Nurse Manager of Surgery and Orthopedics verbalized the restraint orders should have been obtained at the time the restraints were applied or immediately after and the restraint orders for Patient #7 and Patient #12 were not obtained in the required timeframe after the restraints were initiated.

On 01/11/23 at 12:25 PM, the Regulatory and Accreditation Specialist verbalized the orders for the restraints should have been entered immediately.

The facility policy titled "Restraint and Seclusion," effective 12/2022, documented the facility policy required an order for restraints to be obtained from a physician or licensed independent practitioner responsible for the care of the patient prior to the application of restraints. In an emergency application situation, the order would be obtained either during the emergency application or immediately (within approximately 15 minutes) afterwards.

Based on interview, clinical record review, and document review, the facility failed to ensure an order for restraints was renewed every calendar day for 1 of 12 patients sampled for restraint compliance (Patient #7).

Findings include:

Patient #7

Patient #7 was admitted to the facility on 12/27/22, with diagnoses including colon cancer, acute hypoxic respiratory failure, and cardiogenic shock.

A Restraint Summary Flowsheet documented restraints were initiated on Patient #7 on 01/01/23 and were continued through 01/11/23.

The clinical record for Patient #7 lacked restraint orders for the days of 01/04/23 and 01/08/23.

On 01/11/23 at 12:25 PM, the Regulatory and Accreditation Specialist (RAS) verbalized an order had to be entered every calendar day when the restraints were continued. The RAS confirmed the clinical record for Patient #7 lacked restraint orders for 01/04/23 and 01/08/23.

The facility policy titled "Restraint and Seclusion," effective 12/2022, documented if a patient remained in restraints for more than 24 hours, then a new order would be obtained. A new order would be obtained for every calendar day a patient remained in restraints.

Based on observation, interview, record review and document review, the facility failed to:

1) The facility's governing body failed to ensure a contracted Certified Registered Nurse Anesthetist (CRNA) received training to provide services in a safe manner resulting in a significant and lethal medication error.

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated care to its patients.

Based on observation, interview, clinical record review, and document review, the facility failed to ensure a process was in place to ensure nursing standards of practice for safe medication administration were followed during administration of anesthesia in the operating room resulting in the death of an obstetrical patient (Patient #1) and having the potential to impact all patients undergoing procedures requiring administration of anesthesia by a Certified Registered Nurse Anesthetist (CRNA).

Findings include:

Patient #1

Patient #1 was admitted to the facility on 12/19/22, for primary low transverse cesarean section due to placenta previa at 37 weeks and one day.

A Procedure Note, dated 12/19/22, documented a CRNA had administered spinal anesthesia with a start time of 7:50 AM and an end time of 7:52 AM. The anesthetic administered was the following:

- morphine sulfate 0.5 milligrams (mg)/milliliter (ml), two ml administered intravenously at 7:50 AM.
- Fentanyl 0.05 mg/ml injection, 25 micrograms (mcg) administered intrathecally at 7:50 AM.
- bupivacaine 0.75 percent (%) in dextrose injection, two ml administered perineurally at 7:52 AM.

A Postprocedural Note, dated 12/19/22, documented the Anesthesia Post Evaluation was completed in the Intensive Care Unit (ICU). The patient had been admitted to the ICU and placed on sedation and ventilator. Digoxin had inadvertently been placed in the intrathecal space.

CRNA Event Charting, dated 12/19/22, documented the following:

- at 7:47 AM, the CRNA began preparing the patient for an anesthetic.
- at 8:27 AM, the procedure was started.
- at 9:08 AM, the procedure ended.
- at 9:35 AM, the patient was moved to a hospital bed for transport to the unit and the patient stated the patient felt weird.
- at 9:40 AM, patient was in post anesthesia care unit (PACU). The patient's ability to communicate was declining. The Anesthesiologist was called to the bedside, apnea (a temporary cessation of breathing) was noted, and a rapid response (a team of clinicians with critical care expertise) was called to the bed side. An ambubag and face mask with 100% oxygen was started. The patient became unresponsive over the course of five minutes. The patient was immediately intubated and was admitted to the ICU.
- at 10:15 AM, inadvertent digoxin administration into the intrathecal space was suspected and a digoxin level was ordered.

A digoxin level for Patient #1, dated 12/19/22, documented the patient had a digoxin level of 0.7 nanograms per ml.

An OR Nursing note, dated 12/19/22, documented upon attempt of the patient's spinal by the CRNA the patient stated the patient felt pressure at the injection site and was unable to lay down. After completion of the procedure the circulating RN noticed a drooping on the left side of the patient's face and irregular motion of the patient's eyes. The patient repeatedly stated the patient vision was very blurry, the patient was unable to focus, and the patient felt dizzy and tired. The RN performed a neurological assessment. Weakness was noted on the left side during the examination. Upon leaving the main OR the patient became less responsive and required reminders to breathe adequately. Upon arrival to the OB PACU the patient was placed on oxygen at four liters per minute (lpm) via nasal cannula due to low oxygen saturations (below 90%). The OB charge nurse was alerted of the patient's status. The patient was placed on 10 lpm of oxygen via a non-rebreather mask due to continued desaturations below 80%. The OB physician on call was informed of the patient's status. The OB physician arrived at the bedside and called a rapid response due to the patient's deteriorating status. The patient was intubated and sent to the ICU.

A Discharge Summary: Death Note, dated 12/21/22, documented the patient had been admitted for primary low transverse cesarean section due to placenta previa at 37 weeks and one day. The patient underwent an uncomplicated procedure but decompensated in the PACU and a rapid response was called. The patient was intubated and taken to the ICU. It was subsequently revealed the patient had received digoxin in the patient's spinal canal. Imaging studies confirmed no blood flow to the brain and tonsillar herniation. The patient was declared deceased. The preliminary cause of death was brain death due to medication toxicity (medication error).

An undated statement from the CRNA documented the CRNA had begun preparation for the cesarean section procedure in OR six by pulling the drugs needed from the Pyxis (an automated medication dispensing system). The CRNA pulled what the CRNA thought to be bupivacaine from the second drawer. The CRNA pulled a vial, verified the date, and placed the vial on top of the pyxis with the other medications (fentanyl and morphine). The CRNA labeled a syringe for the bupivacaine, verified the date again, drew up the medication, and placed the vial on top of the Pyxis. The CRNA then verified the date a third time prior to throwing the vial in the sharp's container. Once the patient entered the room, the CRNA prepped the patient and accessed the intrathecal space on the first attempt. The medications were then administered intrathecally.

A note from the Director of Corporate Responsibility and Enterprise Risk, dated 12/19/22, documented the CRNA reported the CRNA had been unfamiliar with OR six. The patient was given a medication via the spinal route and the medication was thought to be bupivacaine pulled from the Pyxis. The medication was not effective. The patient started having symptoms in recovery causing the CRNA to question what was given in the OR. The CRNA admitted the CRNA had checked the dates but not the drug labels. The CRNA stated the Digoxin should not have been in the Pyxis and was not in the Pyxis in the OR in labor and delivery.

A photograph of the digoxin ampule used, dated 12/27/22, showed an ampoule with digoxin injection in white lettering against a blue background. The back of the vial documented for slow intravenous or deep intramuscular use in blue writing against a white background.

On 01/09/23 at 1:45 PM, an RN who had been in the OR during the event on 12/19/22, verbalized the CRNA had not called out the medications the CRNA administered and verifying the medications administered with the CRNA was not part of the facility practice in the OR.

On 01/09/23 at 5:36 PM, the OR nurse manager verbalized the medication administration policy for the OR was the same as medication administration policy for the rest of the facility. The practice in the OR did not include a second staff member verifying the medications pulled from the Pyxis and administered by anesthesia and anesthesia did not scan a barcode on the medication or the barcode on the patient's wrist band prior to administration. The nurse manager verbalized the main OR did not have a dedicated OR for OB patients.

The facility policy titled "Medication Administration - Including Intravenous Medication," dated 12/15/21, documented to ensure patient safety, a bar coding process (BCMA) would be used when administering medications. The administration process included
the following:

- The nurse would obtain the medication and take the unit dose to the bedside with the barcode intact.
- Before administering any medication, the nurse would check the "five rights" (right patient, right drug, right dose, right route, and right time).
- At the bedside, the nurse would access BCMA.
- Scan the patient wristband.
- Scan the medication.


43310

On 01/09/23 at 11:38 AM, the Regulatory and Accreditation Specialist (RAS) communicated the process for collecting medication to be administered in the operating room (OR) did not include a scan of medication labels. The RAS explained to access medications stored in the Pyxis (an automated medication dispensing system) a password was entered. Entering a password unlocked Pyxis drawers #1 and #2. Draw #1 and Drawer #2 contained multiple vials, bottles, and ampules of different medications, each stored in a separate section of the drawer. Opening a drawer caused an automated map to open on the screen of the computer terminal dedicated to the Pyxis. The map mirrored the sections of the opened drawer and was labeled with the name of the medication in each section.

The expectation was the individual accessing the drawer would manually select the desired medication on the terminal screen and remove the medication from the corresponding drawer. The RAS confirmed medication could be removed from the Pyxis without selecting the medication on the computer screen. The RAS communicated the CRNA did not select the medication on the map prior to removing the medication from the Pyxis.

On 01/09/23 at 1:25 PM, an OR Pyxis machine was viewed with the Director of Quality (DOQ) and the Manager of Pharmacy Services (MPS). The empty Pyxis was labeled to indicate the sections of the Pyxis where digoxin and bupivacaine were kept in the OR suites. The DOQ and the MPS confirmed the Pyxis was labeled to match the OR Pyxis used during Patient #1's surgical procedure. Each drawer consisted of 6 columns and eight rows. A section used for a medication could use one or more spaces. The medications were stored as follows:

-Digoxin was stored in drawer #1, slot #48. Slot #48 was found in row #1, column #6.
-Bupivacaine was stored in drawer #2, slot #26. Slot #26 was found in row #4, column #2.

On 01/09/23 at 1:46 PM, the DOQ communicated when the CRNA removed digoxin from the Pyxis, the CRNA admitted the CRNA looked at the expiration date but did not verify the medication was the correct medication (bupivacaine) prior to injecting digoxin into Patient #1's intrathecal space (spine).

On 01/09/23 at 5:24 PM, DOQ communicated there was not a process in place to verify the correct medications were removed from the Pyxis, such as confirmation by a second licensed individual.

On 01/09/23 at 5:33 PM, The Operating Room Manager/Registered Nurse (ORM/RN)confirmed the facility did not have a process in place for the verification of medications being removed by CRNAs and/or Anesthesiologist from the OR Pyxis machines drawers.

Based on observation, document review, and interview the facility failed to ensure a policy regarding medication administration in operating rooms was developed and implemented.:

1) The Operating Room Manager/Registered Nurse (ORM/RN) confirmed the facility did not have a process in place for the verification of medications being removed by Certified Registered Nurse Anesthetist (CRNA) and/or Anesthesiologist from the OR Pyxis machines drawers. The ORM/RN confirmed the hospital did not have a policy related to medication administration in the OR.

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated care to its patients.

Based on observation, document review, and interview the facility failed to ensure a policy regarding medication administration in operating rooms was developed and implemented.

Findings include:

On 01/09/23 at 11:38 AM, the Regulatory and Accreditation Specialist (RAS) communicated the process for collecting medication to be administered in the operating room (OR) did not include a scan of medication labels. The RAS explained to access medications stored in the Pyxis (an automated medication dispensing system) a password was entered. Entering a password unlocked Pyxis drawers #1 and #2. Draw #1 and Drawer #2 contained multiple vials, bottles, and ampules of different medications, each stored in a separate section of the drawer. Opening a drawer caused an automated map to open on the screen of the computer terminal dedicated to the Pyxis. The map mirrored the sections of the opened drawer and was labeled with the name of the medication in each section.

The expectation was the individual accessing the drawer would manually select the desired medication on the terminal screen and remove the medication from the corresponding drawer. The RAS confirmed medication could be removed from the Pyxis without selecting the medication on the computer screen.

On 01/09/23 at 5:33 PM, The Operating Room Manager/Registered Nurse (ORM/RN) confirmed the facility did not have a process in place for the verification of medications being removed by Certified Registered Nurse Anesthetist (CRNA) and/or Anesthesiologist from the OR Pyxis machines drawers. The ORM/RN confirmed the hospital did not have a policy related to medication administration in the OR.

Based on record review and interview the facility failed to complete all areas of the informed consent for four patients (#28, 29, 30, and 31).

Findings include:

P#28 admitted 12/12/22 procedure labor epidural, cesarean section, all 6 record review elements present; however, the mode of anesthesia was not indicated by checking box and cesarean section did not have box checked for department of anesthesiology (separate informed consent).

P#29 admitted 12/12/22 procedure spinal anesthesia, cesarean section, all 6 record review elements present; however, Repeat Cesarean section consent did not have the box checked for department of anesthesiology (separate informed consent).

P#30 admitted 12/13/22 procedure spinal anesthesia, cesarean section, all 6 record review elements present; however, Repeat Cesarean Section with bilateral tubal ligation consent did not have the box checked for department of anesthesiology (separate informed consent).

P#31 admitted 12/13/22 procedure regional anesthesia, cesarean section, all 6 record review elements present; however, Primary Cesarean Section consent did not have the box checked for department of anesthesiology (separate informed consent).

The Regulatory and Accreditation Specialist explained the expectation would be for all portions of the consent to be documented appropriately. The box for department of anesthesiology (separate informed consent) should have been checked on all consents utilizing anesthesiology during the procedure.



43310

Based on record review, interview and document review the facility failed to ensure procedure and and/or anesthesia consents were obtained prior to performing a surgical procedure for 4 of 21sampled patients (Patient #17, #16, #15, and #14).

Findings include:

Patient #17

Patient #17 was admitted to the facility on 12/17/22, with a diagnosis of pregnancy.

Patient #17's clinical record documented the patient had a Caesarean Section (C-section), low transverse, completed at the facility on 12/17/22.

Patient #17's clinical record lacked documented evidence a consent for anesthesia and a procedure consent were completed and signed prior to performing a C-section on 12/17/22.

On 01/11/23 at 12:49 PM, the Manager of Medical Staff Services (MMSS) and the Director of Quality (DOQ) confirmed Patient #17's clinical record did not include a signed anesthesia consent and/or a signed procedure consent for a C-section performed on 12/17/22.

Patient #16

Patient #16 was admitted to the facility on 12/26/22, with a diagnosis of pregnancy.

Patient #16's clinical record documented the patient had a Caesarean Section (C-section), low transverse, completed at the facility on 12/26/22.

Patient #16's clinical record lacked documented evidence a procedure consent was completed and signed prior to performing a C-section on 12/26/22.

On 01/11/23 at 1:55 PM, the MMSS confirmed patient #16's clinical record did not include a signed procedure consent for a C-section performed on 12/26/22.

Patient #15

Patient #15 was admitted to the facility on 12/22/22, with a diagnosis of pregnancy.

Patient #15's clinical record documented the patient had a Caesarean Section (C-section), low transverse, completed at the facility on 12/24/22.

Patient #15's clinical record lacked documented evidence a procedure consent was completed and signed prior to performing a C-section on 12/24/22.

Patient #14

Patient #14 was admitted to the facility on 12/28/22, with diagnosis of pregnancy.

Patient #14's clinical record documented the patient had a Caesarean Section (C-section), low transverse, completed at the facility on 12/28/22.

Patient #14's clinical record lacked documented evidence a consent for anesthesia and a procedure consent were completed and signed prior to performing a C-section on 12/28/22.

On 01/11/23 at 2:07 PM, the MMSS and the DOQ confirmed patient #15's clinical record did not include a signed procedure consent for a C-section performed on 12/24/22, and confirmed Patient #14's clinical record did not include a signed a procedural consent and/or a signed anesthesia consent for a C-section completed on 12/28/22.
The facility policy titled "Informed Consent," dated 02/05/18, documented an informed consent was obtained from the patient prior to an elective surgery or any complex procedure.

Based on interview, review of training documents, Pyxis assignment form, documentation of the event from 12/19/22 The contracted CRNA had a start date with the facility of 06/06/22 and Director of Corporate Responsibility and Enterprise Risk, the facility failed to include delineation of per-anesthesia and post-anesthesia responsibilities resulting in the death of a patient.

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated care to its patients.

Based on interview, review of training documents, Pyxis assignment form, documentation of the event from 12/19/22 The contracted CRNA had a start date with the facility of 06/06/22 and Director of Corporate Responsibility and Enterprise Risk, the facility failed to include delineation of per-anesthesia and post-anesthesia responsibilities resulting in the death of a patient.

Findings include:

An email chain regarding the CRNA's training, documented the Provider Liaison had spoken with the CRNA and the CRNA was proficient in the use of the Pyxis (an automated medication dispensing system) on 06/03/22. The response from the pharmacy representative on 06/06/22, was the CRNA was good to go.

A Pyxis Med station Assignment form for the CRNA, dated 06/03/22, was signed by the CRNA but lacked signatures from a manager or pharmacist.

An undated statement from the CRNA regarding a medication error in the Operating Room (OR) on 12/19/22, documented the CRNA had begun preparation for the cesarean section procedure in OR six by pulling the drugs needed from the Pyxis. The CRNA pulled what the CRNA thought to be bupivacaine from the second drawer. The CRNA pulled a vial, verified the date, and placed the vial on top of the pyxis with the other medications (Fentanyl and morphine). The CRNA labeled a syringe for the bupivacaine, verified the date again, drew up the medication, and placed the vial on top of the Pyxis. The CRNA then verified the date a third time prior to throwing the vial in the sharp's container. Once the patient entered the room, the CRNA prepped the patient and accessed the intrathecal space on the first attempt. The medications were then administered intrathecally.

A note from the Director of Corporate Responsibility and Enterprise Risk, dated 12/19/22, documented the CRNA reported the CRNA had been unfamiliar with OR six. The patient was given a medication via the spinal route and the medication was thought to be bupivacaine pulled from the Pyxis. The medication was not effective. The patient started having symptoms in recovery causing the CRNA to question what was given in the OR. The CRNA stated the Digoxin should not have been in the Pyxis and was not in the Pyxis in the OR in labor and delivery.