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Based on a review on medical record review, a review policies and procedures, and staff interviews, it was determined the facility failed to provide one patient (P#1) out of six sampled with informed consent of treatment, when P#1 expressed a documented allergy to succinylcholine (a paralytic medication used in anesthesia) and requested alternative methods used. P#1 was documented to receive succinylcholine during the procedure.

A review of the medical record revealed that P#1 had a medical history of Kalemic Periodic Paralysis (a neuromuscular disorder that causes occasional episodes of muscle weakness), ulcerative colitis (a condition where inflammation and ulceration of the colon and rectum was observed), and anesthesia complications, in which prolonged-progressive neuromuscular paralysis can be induced when particular anesthetic drugs are administered such as succinylcholine (also known as suxamethonium, a medication used to cause short-term paralysis as part of general anesthesia).

On 8/8/22 at 6:43 a.m., a nursing note detailed that a pre-operative (Pre-OP) nurse informed anesthesia of the patient allergy and previous complications from anesthesia. On 8/8/22 at 7:28 a.m., a second time-out was conducted, noted as a pre-procedure time-out, which encompassed: the correct patient, correct site, correct side, correct procedure, identification of the site marked, a completed health and & physical (H&P) note on file, verification of consents, and a review of allergies. Further review revealed that an anesthesia Pre-procedure evaluation was performed by Medical Doctor (MD) CC on 8/8/22 at 7:40 a.m. listing the patient allergy and associated reactions and the plan discussed with the P#1 and a Physician Anesthesia Assistant (PAA).

On 8/8/22 at 7:41 a.m., PAA AA administered succinylcholine, propofol (a medication that results in a decreased level of consciousness), versed (medication used for anesthesia or procedural sedation used to induce sleep), and lidocaine (a local anesthetic used to relieve pain).

On 8/8/22 at 11:10 a.m., an assessment note revealed that P#1 was able to move all four extremities voluntarily or on command, and able to stand/walk. Further review revealed that a notation noted that P#1's spouse indicated weakness of the lower extremities related to anesthesia.

On 8/8/22 at 11:17 a.m., P#1 was discharged from the facility to home. On 8/9/22 at 11:02 a.m., a post-operative (PostOP) call was conducted by nursing services which revealed that there were no complaints from P#1 related to the surgical site, however P#1 stated being unable to use their arms or legs and this was brought to the attention of MD BB. On 8/11/22 at 8:05 a.m., MD CC noted communication with P#1 regarding the concerns.

A review of the facility's policy entitled, "Patient Rights and responsibilities", # RI-01-01, last revised 05/2013, revealed that the purpose of the policy was to detail a process to delineate the rights and responsibilities that patient has within the facility. Further review revealed that patients have the right to receive information, including names and roles of individuals responsible for providing care, treatment, and services. Further review revealed that diagnosis and treatment options, information about outcomes of care, treatment, and services including unanticipated outcomes should be provided. Further review revealed that patients should be participants in the decisions about care, treatment, and services, have plain managed, and refuse care, treatment, and services. Further review revealed that patients have a responsibility to provide complete and accurate information on all matters related to health.

A review of the facility's policy entitled, "Assessment of the Patient", #PE-05-01, last revised 4/2/20, revealed that the purpose of the policy was to detail parameters for assessment and reassessment of the patient for each discipline or site of care. Further review revealed that for patients in surgical services, a pre-procedural assessment is completed by a Registered Nurse (RN), a pre-anesthesia assessment is done by a Medical Doctor (MD) before induction of anesthesia. A Reassessment is performed immediately before induction of anesthesia. Further review revealed that for patients in the post-anesthesia care unit (PACU), an assessment is performed on arrival by the RN and a reassessment is performed at a minimum of every 30 minutes. Further review revealed that for physicians and mid-level providers, a medical history and physical examination is completed no more than 30 days prior to, or within 24 hours after registration, but prior to surgery or a procedure requiring anesthesia services. For a medical history and physical examination that was completed within 30 days prior to registration or inpatient admission, an update documenting any changes in the patient's condition is completed with 24 hours after registration, but prior to surgery or a procedure requiring anesthesia services. Further review revealed that post-procedural progress notes are completed immediately after any invasive procedure and progress notes are recorded for continuity of care with physician reassessment when there is a change in condition and according to established standards of practice.

During an interview on 8/23/22 at 12:40 p.m. in the conference room with RN II, RN II stated that RN II has been with the facility for two years. RN II stated that when a patient is received from the pre-operative (Pre-OP) area, before they are moved a first time out is performed where two patient identifiers, allergies, and confirmation of the surgery with the patient is reviewed. RN II stated a second time out is performed upon entry into the room with the same information. RN II stated a third time-out occurs with the entire procedural team, both surgical and anesthesia. RN II stated that the third time-out includes, but is not limited to: patient allergy, code status, surgical site, patient fire risk, patient identifiers, and an allergy band check. RN II stated that patient allergies are always written on the board, however if the list is very long a selection of common allergies are written. RN II stated that if the patient has one allergy, it is always written on the board. RN II stated that if the wrong site is marked, the team will not proceed until the information is reviewed and a new consent is obtained, if applicable. RN II stated that if the anesthesia team must switch personnel, for any reason, RN II has heard a handoff or report given, orally. RN II stated that once the procedure is over, a debrief is performed but it does not include the anesthesia team. RN II stated that the debrief reviews the surgery, counts of surgical material, and patient recovery.

During an interview on 8/23/22 at 1:30 p.m. in the conference room with RN JJ, RN JJ sated that they have been with the facility since March 2022 and has been an operating room (OR) RN for over 15 years. RN JJ stated that the first time-out is performed in the block room or in PreOP, which includes patient identifiers and patient confirmation of the procedure. RN JJ stated the second time-out is usually performed by the CST in the presence of an RN to again confirm the aforementioned information. RN JJ stated that the first time-out is performed prior to any incision, which includes patient identifiers, procedure confirmation, identification of the surgeon performing the surgery, patient allergies, patient fire risk, and code status. RN JJ stated that nurses will check the armband for an allergy and compare it to what is in the electronic medical record (EMR). RN JJ stated that the third time-out includes the anesthesia team along with the surgical team. RN JJ stated that patient allergies are written on a board for the procedural team to view. RN JJ stated that a debrief time-out will occur at the end of the procedure but does not include the anesthesia team. RN JJ stated that if the anesthesia team switches personnel, RN JJ has seen an oral handoff performed. RN JJ stated that a CRNA or PAA may continue monitor and administration of anesthesia medication without an anesthesiologist physically present, but the anesthesiologist must be immediately accessible physically. RN JJ stated that once procedure is finished, the patient is taken to recovery in the post-anesthesia care unit (PACU). RN JJ stated that anesthesia personnel document their own medications.

An interview was requested with both PAA AA and MD CC during the time of the survey. Both PAA AA and MD CC declined to meet with the surveyor.

It was determined that the facility failed to inform P#1 that she would receive succinylcholine during her procedure prior to the procedure on 8/8/22.

Based on a review on medical record review, a review policies and procedures, and staff interviews, it was determined the facility failed to safely delivery medications to one patient (P#1) out of six when P#1 expressed a documented allergy to succinylcholine (a paralytic medication used in anesthesia) and requested alternative methods used. P#1 was documented to receive succinylcholine during the procedure.

A review of the medical record revealed that P#1 had a medical history of Kalemic Periodic Paralysis (a neuromuscular disorder that causes occasional episodes of muscle weakness), Ulcerative colitis (a condition where inflammation and ulceration of the colon and rectum is observed), and anesthesia complications, in which prolonged-progressive neuromuscular paralysis can be induced when particular anesthetic drugs are administered such as succinylcholine (also known as suxamethonium, a medication used to cause short-term paralysis as part of general anesthesia).

On 8/8/22 at 6:43 a.m., a nursing note detailed that a pre-operative (Pre-OP) nurse informed anesthesia of the patient allergy to succinylcholine and previous complications from anesthesia. Further review revealed that an anesthesia Pre-procedure evaluation was performed by Medical Doctor (MD) CC on 8/8/22 at 7:40 a.m. listing the patient allergy and associated reactions and the plan discussed with P#1 and a Physician Anesthesia Assistant (PAA AA).

On 8/8/22 at 7:41 a.m., PAA AA administered succinylcholine, propofol (a medication that results in a decreased level of consciousness), versed (medication used for anesthesia or procedural sedation used to induce sleep), and lidocaine (a local anesthetic used to relieve pain). On 8/8/22 at 8:04 a.m., a third time-out was conducted, noted as a pre-incision time-out, which encompassed: the correct patient, correct site, correct side, correct position, correct position, correct procedure, have all team members been introduced, has the surgeon reviewed the critical steps, has the anesthesiologist review the patient, has the nursing team review the sterility, and has the nursing staff reviewed the equipment for potential problems.

A review of the facility's policy entitled, "Assessment of the Patient", #PE-05-01, last revised 4/2/20, revealed that the purpose of the policy was to detail parameters for assessment and reassessment of the patient for each discipline or site of care. Further review revealed that for patients in surgical services, a pre-procedural assessment is completed by a Registered Nurse (RN), a pre-anesthesia assessment is done by a Medical Doctor (MD) before induction of anesthesia. A Reassessment is performed immediately before induction of anesthesia. Further review revealed that for patients in the post-anesthesia care unit (PACU), an assessment is performed on arrival by the RN and a reassessment is performed at a minimum of every 30 minutes. Further review revealed that for physicians and mid-level providers, a medical history and physical examination is completed no more than 30 days prior to, or within 24 hours after registration, but prior to surgery or a procedure requiring anesthesia services. For a medical history and physical examination that was completed within 30 days prior to registration or inpatient admission, an update documenting any changes in the patient's condition is completed with 24 hours after registration, but prior to surgery or a procedure requiring anesthesia services. Further review revealed that post-procedural progress notes are completed immediately after any invasive procedure and progress notes are recorded for continuity of care with physician reassessment when there is a change in condition and according to established standards of practice.

A review of the facility's policy entitled, "Medication Administration", #MU-50-01, last revised 04/2018, revealed that the purpose of the policy was to detail a process for the administration of medication. Further review revealed that the following information be included and performed: documentation of the medication order, medication dose and device verification, education, and documentation. Further review revealed that staff should ensure the patient is not allergic to the medication being administered by check the allergy armband or asking the patient. Staff should utilize two approved patient identifiers to identify the patient and to check the medication label to ensure accuracy.

A review of the facility's policy entitled, "Medication Errors and Adverse Drug Reactions", #MU-55-01, last revised 05/2019, revealed that the purpose of the policy was to detail a process to identify, respond to, and report actual, or potential medication errors and adverse drug reactions. Further review revealed that when responding to medication errors and adverse drug reactions, staff should provide necessary care to the patient and notify the prescriber immediately when a medication administration error, adverse drug reaction, and/or medication compatibilities or medication issues are identified. Further review revealed that the event should be reported to the facility system wide medication safety committee and any significant medication errors to external reporting agencies.

A review of the facility's policy entitled, "Delivery of Anesthesia Care", #ANES-05, last published 8/19/22, revealed that the purpose of the policy was to define a process of minimal anesthesia care standards. Further review revealed that all patients receiving anesthesia or sedation should have a pre-anesthesia evaluation within 48 hours prior to surgery or a procedure requiring anesthesia services. The pre-anesthesia evaluation shall include, but is not limited to:
1.Interview/examination of the patient
2.Airway evaluation and pertinent physical examination
3.Notation of Anesthesia Risk
4.Review of the medical history, including anesthesia, drug, and allergy history
5.Any potential anesthesia problems identified, particularly those that may suggest potential complications or contraindications to the planned procedure
6.Additional pre-anesthesia evaluation
7.Development of the plan for the patient's anesthesia care, including the type of medications for induction, maintenance, postoperative care, and discussion with the patient of the risks and benefits of the delivery of anesthesia
8.Patients condition prior to induction of anesthesia.

During an interview on 8/23/22 at 2:00 p.m. in the conference room with Assistant Nurse Manager (ANM) GG, ANM GG stated that ANM GG has been with the facility for four years but an RN for 32 years. ANM GG stated that a follow-up survey was made to P#1 by a charge nurse and the results of the follow was brought to ANM GG's attention. ANM GG stated that ANM GG spoke with P#1 and learned that P#1 spoke with personnel from the anesthesia department in regard to treatment options or monitoring but was unsure with whom P#1 spoke with from the anesthesia department. ANM GG followed up with P#1 since learning of the incident and P#1 reported recovery over time. ANM GG stated that P#1 reported that there was no error on behalf of the nursing team to P#1's recollection and ANM GG validated this in a chart review. ANM GG stated that P#1 stated that P#1 reported not having symptoms from the medication error until making it home.

During a telephone interview on 8/23/22 at 2:40 p.m. with Physician Anesthesia Assistant (PAA) KK, PAA KK stated that PAAs do not typically call out medication administered unless there was a concern. PAA KK stated that the Anesthesiologist must be present during induction but may leave after and allow the PAA to assume care. PAA KK stated that the anesthesia team is present during the pre-incision time-out and allergies are reviewed during this time. PAA KK stated that the anesthesia personnel should check the allergy band on the patient and on the chart. PAA KK stated that anesthesia personnel document their own medications. PAA KK stated that if a patient is allergic to a medication and a consideration for administration by the anesthesia assistant is present, the assistant must consult the anesthesiologist. PAA KK stated that if anesthesia personnel must switch off, for any reason, a handoff detailing medication administered, allergies, and patient information is conducted.

During a telephone interview on 8/24/22 at 10:05 a.m. with Clinical Informatics Specialist (CLS) LL, CLS LL stated CLS LL has been with the facility for 26 years, in the position for two years and has a specialty in OR and anesthesia training for the electronic medical record (EMR). CLS LL stated that when a provider, in the OR or anesthesia personnel, documents a medication that a patient has a listed allergy to, the EMR will prompt the provider with an allergy note. CLS LL stated that they prompt will ask the provider to override the medication with the option to leave a comment or the provider may simply override and opt not to leave a comment.
An interview was requested with both PAA AA and MD CC during the time of the survey. Both PAA AA and MD CC declined to meet with the surveyor.