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Based on interviews and document reviews, the hospital failed to meet the requirements related to identifying and reducing medical errors as part of its quality improvement program. Specifically, the hospital's quality assessment and performance improvement efforts did not adequately "show measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors" with regards to heparin medication (a high alert blood thinner) administration. Despite known issues with insulin (a high alert blood sugar medication) dose calculation errors, the hospital did not carefully review other high-alert medications like heparin drips to identify risks and opportunities for improvement in line with protocol adherence.

Findings:

During an interview and record review on 2/27/24 at 11:45 am, the Director of Pharmacy (DOP), Staff Pharmacist I, and the Director of Intensive Care Unit discussed the following medication errors:

*Patient 1 received heparin (medication used to prevent blood clotting) therapy as a preventive measure against blood clots, with dosages adjusted based on Activated Partial Thromboplastin Time (aPTT a screening test that helps evaluate a person's ability to appropriately form blood clots) levels. RN 1 administered a significant underdose (400 units instead of 4000 units), and RN 2 made dosage errors, including an underdose based on aPTT 35 and failure to follow protocol at aPTT 90. These deviations from protocol pose risks of compromised anticoagulation and violate hospital policy.

*Patient 2, with a history of heart problems, had heparin dosages adjusted by protocol. RN 3 administered an excessive bolus (4000 units instead of 3500 units), risking potential bleeding complications. RN 4 failed to administer a prescribed bolus at aPTT 28, violating protocol. The ICU Director emphasized adherence to protocol even if Electronic Medical Record lacks information.

*Patient 3 received heparin for clot prevention, with RN 5 administering a lower infusion rate (13 mL [milliliter] per hour instead of 14 mL per hour) at aPTT 29. This deviation could lead to suboptimal anticoagulation, increasing the risk of complications. Adherence to dosage protocols is crucial for patient safety and optimal treatment outcomes in heparin administration.

During an interview on 2/28/24 at 8:00 am, with the DOP, he acknowledged that the hospital had a history of insulin medication errors like the heparin medication errors that occurred. He admitted that the hospital had not specifically examined heparin administration and was unaware of any reported errors or issues related to heparin. He also recognized that the root cause of the insulin medication errors was the complexity and confusion surrounding the orders and acknowledged that heparin orders shared similar challenges in terms of dose calculation. The DOP conceded that the hospital should have reviewed other high-risk medications, including heparin, to identify potential difficulties in calculating correct doses and reduce the risk of similar errors, as part of its quality improvement efforts in medication safety and prevention of errors.

This resulted in the occurrence of multiple heparin dose calculation errors by nurses for three identified patients, with incorrect or missed administration of heparin doses. The hospital failed to "track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning". Even when made aware of these heparin medical errors, the Director of Pharmacy admitted the hospital had not specifically examined risks relating to heparin administration as part of its quality improvement efforts.

During an interview on 2/28/24 at 9:09 am, the Quality Director stated they did not proactively identify heparin dose administration and calculation as an area needing performance improvement focus to prevent medical errors. She acknowledged analysis of high-alert medication risk areas and implementing preventive actions could have identified issues with heparin dose protocols and calculations to avoid the medication errors that took place across multiple patients.

Based on interview, and record review, the facility failed to ensure the safety of Patient 6 when Registered Nurse (RN) 25, who had been floated to the Telemetry unit (a unit for patients requiring procedures or medications administered by nurses with advanced skills, but a lower level than Intensive Care, and that require cardiac monitoring/interventions) from a lower-acuity unit, administered a cardiac drip (a solution containing a medication that affects the rate/rhythm of the heart) to Patient 6 as RN 25 believed it was expected of him to do so, as he had had the training, but no return demonstration of competency. This failure exposed Patient 6 to possible negative health outcomes, up to and including death.

Findings:

A facility policy titled, "Patient Safety Plan," revised on 11/2022, was reviewed. The policy indicated that the purpose of the patient safety plan is to "assure that a planned, systematic, coordinated approach exists to improve patient safety and reduce risk to patients." "The leaders of the organization maintain responsibility for proper collection and dissemination of information for continuing education pertaining to the patient safety program to employees," and, "the leaders will collaborate in decision making which affects the development of hospital wide patient care programs; policies and procedures that describe how patient care needs are met."

A facility policy titled, "IV Therapy: Administration of Intravenous Medications," revised 10/2023, was reviewed. The policy indicated amiodarone, a cardiac medication given to stabilize irregular/rapid heart rhythms, is approved to be administered on the telemetry unit. Adverse effects include "hypotension (low blood pressure), especially with the loading dose."

Patient 6 was admitted to the facility on 10/5/23 with diagnoses which included cancer of the lung, coronary artery disease (reduced blood flow to the cardiac muscle due to build-up of plaque in the arteries of the heart), and diabetes (a chronic disorder that affects how the body converts food into energy).

Patient 6's discharge summary dated 10/10/23 by MD 7 was reviewed. MD documented that Patient 6 had developed rapid atrial fibrillation (a condition of the heart where both upper chambers beat too fast and irregularly) during the admission that required amiodarone.

During an interview on 2/26/24 at 11:56 am, RN 28 stated she had been given some training on cardiac medications but was not a telemetry nurse, and won't administer cardiac medications, and stated, "I refused, I'm not doing it", and added that she had gotten some pushback for refusing.

During an interview on 2/26/24 at 12:09 pm, RN 29 stated, they don't give us the patients with drips when we float to telemetry.

During an interview on 2/26/24 at 3:33 pm, RN 25 stated he was a Medical/Surgical nurse and had been floated occasionally to the Telemetry unit and had administered cardiac drips. RN 25 recalled there had been a "crash course" on cardiac medications in HealthStream (an online learning module) and later a power point presentation in a group educational course. There was no hands-on module nor a return demonstration in which RN 25 showed competence with administering cardiac medications before he began administering them. RN 25 stated, "I'm not a tele nurse," and stated discomfort with administering cardiac drips, and had felt pressure to administer them.

Patient 6's physician's order/medication administration record dated 10/8/23 at 7:15 am was reviewed. Medical Doctor (MD) 6 ordered a loading dose of amiodarone 150 mg (milligrams, a unit of measure) in 100 mL (milliliters, a unit of measure) of solution, at 600 mL/hour, to be infused over 10 minutes, to be followed by a maintenance/continuous dose of amiodarone 360 mg in 200 mL of solution, at 33 mL/hour. RN 25 administered the medications ordered, the initial dose at 10:33 am, and the maintenance dose at 10:42 am.

RN 25's "orientation checklist - registered nurse," was reviewed. The checklist included instructions for completion as follows: nurses are required to complete a self-assessment of their clinical skills indicating if they are competent or require additional instruction or supervision; once the skill is completed in front of a preceptor and assistance is no longer needed, then the column "demonstrated independently" is completed. A competency titled Telemetry Addendum outlines "this portion is to be used for those nurses that will be trained in a telemetry/cardiac monitored unit." Both orientation checklists were filled out by RN 25 on 1/17/23. The telemetry addendum included cardiac medications, including amiodarone. On this form, validation of competency instruction outlined that the preceptor was to initial and date the appropriate column when documenting the method of assessment. There were no initials nor dates nor method of assessment in the column below this instruction. In the next column, Self-Assessment by Employee, in the line specified for amiodarone, there was a pen mark under Needs Review/Practice, then a hand-drawn "x" under Competent. In the next column, Independent Demo (demonstration), the line specified for amiodarone is initialed. The initial resembles the handwritten signature for the Ortho/Neuro Director (OND), who was also the Director for the medical/surgical unit, and RN 25's manager.

RN 25's competency transcript was reviewed. RN 25 completed a course titled "Telemetry Float class" on 11/2/23.

During a concurrent interview and record review on 2/28/24 at 1:10 pm, the Clinical Educator reviewed RN 25's orientation checklist and competencies and telemetry addendum, and stated "independent demo" meant the preceptor/trainer had watched a return demonstration by the employee, and as it was signed by the manager, it indicated RN 25 demonstrated knowledge in amiodarone infusion.

During a follow-up concurrent interview and record review on 2/28/24 at 3:27 pm, RN 25 recalled hesitating marking an "x" for competence on the amiodarone drips and started to mark himself as needing review as he still did not feel comfortable starting or maintaining cardiac drips, but felt he had to, because he had had the training. When asked if the OND had confirmed his competence with a return demonstration, he stated he had not done a return demonstration.

During a concurrent interview and record review, on 2/28/24 at 4pm, the OND stated that RN 25 did not do a return demonstration with him, and that OND's initial under "Returned Demo" indicated that the nurse deemed himself competent with the knowledge about the medication, and not the direct administration of it. He stated, nurses that float from the Medical/Surgical unit would not be responsible for a cardiac drip because floating nurses are not given extensive education on drips, that if the floating nurse was given a patient who required a cardiac drip, then the charge nurse or a trained telemetry nurse should initiate and manage the drip. He stated, we gave everyone the education, but floating nurses are not deemed competent to hang the drug. If they get an order to start a drip, they are to contact another nurse to start and manage it. "I verbally told them this is the education component, you're not responsible for the drip, it's education only."

During a concurrent interview, and record review, on 2/28/24 at 5:03 pm, the Discharge Admission Resource and Transfer Registered Nurse (DART RN) confirmed that she had given an in-person PowerPoint instruction to a group of nurses that would be floating to the telemetry unit, in a course titled "Telemetry Float Class," and provided a sample agenda which included a 60-minute presentation on eight cardiac and other drips, including amiodarone. She stated the presentation was to get them familiar with the medications, and that when this class was started in October 2023, they were not meant to be assigned these drips "right off the bat" after the training, but the class was to prepare them and they were expected to administer and manage cardiac medications. She stated, we strongly enforced that there were resources out there they could go to if they got an order for a drip, training materials available and policy, and a binder with resource data on the unit, and the assistance of the charge nurse or another competent nurse. She stated there was an exercise on heparin (an anti-clotting medication) infusion at the end of the presentation but there was no hands-on demonstration nor a return demonstration required on cardiac medication, from those who had been in the class.

During an interview on 2/29/24 at 8:23 am, the Clinical Educator acknowledged that mock scenarios were not the best validation of competency, particularly in emergent settings, and that a lived experience was the best method to demonstrate proficiency.

During an interview on 2/29/24 at 2:35 pm, the Corporate Chief Nursing Officer stated, our telemetry unit is our step-down unit so there are drips and if the nurse floating from medical surgical or ortho/neuro has completed the competency, I would expect them to administer the cardiac drips.

Based on interview and record review, the facility failed to ensure that Patient's 11's medical record was accurate and complete, in written or electronic form, when medical doctor (MD) 8 shredded a POLST (POLST, a record that identifies a patient's wishes regarding medical treatment and must be signed by an MD) that was intimated and signed by Patient 11. As a result, Patient 11's medical record had no documentation of his resuscitation wishes for a period of time that he remained in the facility.

Findings:

A review of the facility's policy titled, "Resuscitation Status," dated 6/22, indicated that the policy's purpose was to recognize that the facility respected the rights of patients to make decisions about their care including resuscitation status. The policy further indicated that "differences of opinion and conflicts may arise with regard to appropriateness of resuscitation status. Every effort is make to comply with the patient's wishes within the limits of the law."

A review of the facility's policy titled "Medical Record Content," dated 9/2020, indicated that every medical record shall contain specific elements that included Advance Directives, Durable Power of Attorney, or Living Will.

A review of medical records indicated that Patient 11 was an 80 year old male admitted to the facility on 2/14/24 to undergo a planned coronary artery bypass graft surgery x 4 (CABG, a surgery that bypasses blocked heart vessels with healthy vessels removed from the leg or chest) scheduled for 2/16/24. On 2/14/24, at 7:08 pm, MD 8 conducted Patient 11's surgical consultation and discussed the risks, benefits, and alternatives to surgery. The consultation indicated that Patient 11 agreed "to not be a Do Not Resuscitate Status" (DNR) for the duration of surgery, and 30 days after surgery, unless the situation is completely helpless." On 2/14/24, at 4:00 pm, a Psychosocial Evaluation conducted by the facility's Associate Clinical Social Worker (ACSW) indicated that Patient 11 requested to change his status from full code to DNR prior to surgery, with comfort-focused treatment, and no artificial means of nutrition. On 2/14/24, untimed, Patient 11 signed a POLST form that indicated Patient 11 desired to be a DNR, with comfort-focused treatment, and no artificial means of nutrition.

During a concurrent interview and record review, on 2/26/24, at 8:20 am, the Director of Performance Improvement (DPI) was asked to provide a full and complete copy of Patient 11's medical record, including a copy of Patient 11's signed POLST. DPI stated that Patient 11 was currently admitted to the facility receiving postoperative CABG care. DPI audited Patient 11's complete electronic health record and Patient 11's current working hard copy chart and did not locate a patient signed POLST. DPI stated there was no evidence of a signed POLST in Patient 11's medical record.

During an interview on 2/27/24, at 10:57 am, RN 10 verified that she was assigned to provide nursing care to Patient 11 on the 2/14/24, day shift, when Patient 11 expressed a desire to change his resuscitation status from a full code to a DNR. RN 10 stated on 2/14/24, the day before surgery, the facility's ACSW assisted Patient 11 with changing his resuscitation status, and spelling out his wishes, on the facility's POLST form. The facility's POLST forms were purposefully colored fluorescent pink, and placed on the front of Patient 11's medical chart, so that it was easily recognizable to alert staff of Patient 11's desire to change resuscitation status.

During an interview on 2/27/24, at 10:17 am, ACSW stated that on 2/14/24, she assisted Patient 11 with documenting his resuscitation wishes on a POLST form the day prior to his CABG surgery, scheduled for 2/15/24. ACSW reported she left the original, bright pink, POLST that Patient 11 signed on the front of his medical record, awaiting MD signature. ACSW reported MD 8 wasn't notified that Patient 11 desired to change his resuscitation status until the morning of surgery, after Patient 11 had already received a sedative (a medication used to relax patients prior to surgery). Since Patient 11 was not coherent to discuss the change in his resuscitation wishes, the CABG surgery was postponed. ACSW reported that MD 8 appeared surprised and agitated over the surgery being cancelled. MD 8 immediately made telephone contact with Patient 11's friend on file and requested for the friend to rescind Patient 11's DNR wishes while Patient 11 was sedated. ACSW stated that since Patient 11 was responsible for his own health care, and did not have a power of attorney (POA, a legal document that grants another person the authority to make health decisions on a patient's behalf) on file, only Patient 11 could make decisions on his health care. After MD 8's telephone conversation with Patient 11's friend, ACSW observed MD 8 placing Patient 11's signed POLST in the facility's shredder bin. ACSW reported the only reason there was evidence of Patient 11's signed POLST was because she happened to make a copy for her office files. ACSW stated five minutes prior to this interview, the facility's DPI discovered that ACSW had proof of Patient 11's signed POLST and requested a copy for the medical record.

During a telephone interview on 2/26/24, at 6:46 pm, RN 18 stated she was the cardiovascular Operating Room (CVOR) nurse assigned to conduct the preoperative checks with Patient 11 and bring him up to the CVOR. RN 18 stated that she wasn't made aware of Patient 11's desire to change his resuscitation status, and newly signed POLST, until after Patient 11 received sedation. Since Patient 11 was not coherent to have an informed discussion on his resuscitation wishes, or the CVOR resuscitation requirements, Patient 11's surgery was temporarily delayed until the facility's administrators decided how to move forward. During this time, MD 8 placed telephone calls to Patient 11's friend, who was not a listed family member or next of kin, to discuss rescinding the DNR and proceeding with surgery. RN 18 stated that after MD 8 spoke with Patient 11's friend, he advised the OR RNs that surgery was back on because he "dealt with the issue and made the POLST disappear."

During an interview on 2/26/24, at 3:57 pm, the facility's perfusionist (PERF, a specialist who operates the heart lung machine during open heart surgery) stated RN 18 reported to PERF that there appeared to be a patient-initiated, DNR / POLST that was initiated and signed by Patient 11 after MD 8 had conducted a surgical consultation confirming Patient 11 was a full code. PERF stated that if a patient initiated paperwork to become a DNR, the patient would have to be involved in rescinding the DNR. PERF reported that he, and the CVOR team, were waiting for the facility's leadership team to decide how to proceed, when MD 8 presented to the OR and advised the CVOR staff to continue preparing for surgery because "he dealt with the POLST issue and made it disappear." PERF stated, when he questioned MD 8 about the details of the POLST, MD 8 stated he shredded the document. PERF reported he had provided care to Patient 11 after this incidence, and confirmed that the Patient 11's paper chart, and electronic record, had no evidence of a previously signed POLST.

During an interview on 2/29/24, at 1:30 pm, the Chief Nursing Officer (CNO) reported that a POLST was not active until it was co-signed by an MD. However, if there was a discrepancy in understanding a patient's wishes, the provider must discuss the contents of the patient's POLST with the patient. CNO stated that he was aware of Patient 11's missing POLST because MD 8 informed the CNO that he shredded Patient 11's POLST document. CNO stated it was his expectations, and the facility's policy, that original medical records were not to be shredded nor disposed. CNO reported that the issue was elevated to the facility's peer-review board for a formal investigation.

Based on interview and record review, the Emergency Department (ED) physician did not document a daily progress note for a mental health patient (Patient 25), who was in the ED overflow unit. This had the potential for a change in the patient's condition to go unrecognized.

Findings:

A review of Patient 25's record indicated she presented to the Emergency Department (ED) on 2/8/24 at 3:57 pm, with suicidal ideations. Mental health evaluated her and she was placed on a mental health hold. She was transferred to the ED overflow area to await disposition. She was transferred to another hospital on 2/10/24 at 8:43 am. There was one physician's note by the ED physician on 2/8/24, but no further notes or physical assessments by a physician were in the record.

During a concurrent interview and record review on 2/28/24 at 2:45 pm, the Director of Performance of Improvement (DPI) confirmed she was unable to find an interval progress note by the ED physician, in the record, but there should have been a daily note. She said the new nursing director of the ED has a new process started to prevent future occurrences.

The Medical Staff Rules and Regulations indicated under progress notes: "The attending physician or an allied health professional with appropriate privileges, must ensure documentation of daily dated hospital visits and progress notes must reflect the condition of the patient and course of therapy, as the patient's condition warrants, and such notes must provide continuity of care and transferability."

Based on interviews and record reviews, the facility failed to adequately develop or update and then implement policies and procedures to identify and minimize drug errors, the facility has had a history of high alert medication errors, and subsequently, heparin also a high alert medication was involved in multiple medication errors. The facility's policy improvements were insufficient to effectively identify and prevent heparin-related medication errors. The absence of an effective response to these recurring medication errors indicates a significant oversight in the facility's approach to patient safety as evidenced by:

1. There were six heparin continuous infusion medication errors identified for three of three patients (Patients 1, 2, and 3) receiving heparin drip. These errors can have severe consequences, including severe injury or even death, as heparin is an anticoagulant that thins the blood and affects the body's ability to form clots. Inappropriate administration of heparin can lead to bleeding complications or inadequate anticoagulation, both of which pose significant risks to patient safety.

2. As a high-risk medication, heparin administration requires a double-check process, in which one nurse prepares and calculates the dose while a second nurse verifies the preparation and calculations before administration. However, this double-check system failed to function effectively at the hospital, as evidenced by the occurrence of multiple continuous infusion heparin medication errors that had been double-checked.

Findings:

1. During an interview and record review on 2/27/24 at 11:45 am, the Director of Pharmacy (DOP), Staff Pharmacist I, and the Director of Intensive Care Unit (ICU)discussed the following medication errors:

*Patient 1 received heparin therapy as a preventive measure against blood clots, with dosages adjusted based on aPTT levels. Registered Nurse (RN) 1 administered a significant underdose (400 units instead of 4000 units), and RN 2 made dosage errors, including an underdose based on aPTT 35 and failure to follow protocol at aPTT 90. These deviations from protocol pose risks of compromised anticoagulation and violate hospital policy.

*Patient 2, with a history of heart problems, had heparin dosages adjusted by protocol. RN 3 administered an excessive bolus (4000 units instead of 3500 units), risking potential bleeding complications. RN 4 failed to administer a prescribed bolus at aPTT 28, violating protocol. The ICU Director emphasized adherence to protocol even if EMR lacks information.

*Patient 3 received heparin for clot prevention, with RN 5 administering a lower infusion rate (13 mL per hour instead of 14 mL per hour) at aPTT 29. This deviation could lead to suboptimal anticoagulation, increasing the risk of complications. Adherence to dosage protocols is crucial for patient safety and optimal treatment outcomes in heparin administration.

During an interview on 2/28/24 at 8:00 am, with the DOP, he acknowledged that the facility had a history of insulin medication errors like the heparin medication errors that occurred. He admitted that the facility had not specifically examined heparin administration and was unaware of any reported errors or issues related to heparin. He also recognized that the root cause of the insulin medication errors was the complexity and confusion surrounding the orders and acknowledged that heparin orders shared similar challenges in terms of dose calculation. The DOP conceded that the facility should have reviewed other high-risk medications, including heparin, to identify potential difficulties in calculating correct doses and reduce the risk of similar errors. He acknowledged that the policy needed to be improved to identify high risk medication errors.

2. During an interview on 2/27/24 at 4:00 pm, the DOP, Staff Pharmacist I, and the Director of Intensive Care Unit discussed the following medication errors and the nurses that double checked these errors. The nurses involved in the double-checking process for the heparin medication errors were as follows:

*For Patient 1: RN 6, RN 7, RN 8, and RN 9
*For Patient 2: RN 10 and RN 11
*For Patient 3: RN 12
These nurses were responsible for verifying the heparin dose calculations and ensuring the correct amount was drawn up prior to administration. However, despite their efforts, errors still occurred, indicating a need to reevaluate and improve the double-check process.

During an interview on 2/27/24 at 4:00 pm, the DOP, Staff Pharmacist I, and the Director of Intensive Care Unit discussed, and it was revealed that seven nurses were involved in double-checking the heparin dose calculations and verifying the correct amount drawn up prior to administration. Despite this double-check process, the calculations were incorrect, and the nurses inadvertently confirmed the errors. This situation highlights a critical breakdown in the double-check system, which was intended to serve as a safety net for catching and preventing medication errors.

During an interview on 2/29/24 at 9:30 am, RN 12 reported that she double-checked and signed off on the heparin dosage for Patient 3, collaboratively calculating the dose and visually verifying the IV pump's rate change to ensure its appropriateness. She mentioned that the computer system's workflow for calculating heparin rate changes is challenging, and discrepancies exist between the protocol and the computer system. The presence of old file cabinets containing outdated protocols and policies contributes to this confusion. For instance, an insulin protocol from 2019 was recently replaced with an updated version from 2023, but the outdated paper protocol was still in circulation. This discrepancy between paper and computer-based protocols, along with the use of outdated paper protocols, often leads to confusion among the nursing staff. In many cases, nurses rely on paper protocols, which may not reflect the most current guidelines, resulting in potential medication errors.

During an interview on 2/29/24 at 11:30 am, RN 10 stated that she double-checked and signed off on the heparin dosage for Patient 2, collaboratively calculating the dose and visually inspecting the medication. She mentioned that using separate protocols for cardiac and deep vein thrombosis (DVT) cases increases the potential for errors, as it is crucial to ensure that the correct protocol is used for each situation-she also mentioned she was not sure if this is what happened. RN 10 also acknowledged witnessing other nurses making similar errors due to the complexity of the process. She highlighted that there are multiple places to calculate the heparin dose, including the electronic medical administration record (eMAR) and paper protocols, which may lead to inconsistencies. Additionally, some of the paper protocols were outdated, further contributing to potential errors. To minimize confusion and enhance medication safety, RN 10 suggested separating the cardiac and DVT protocols and ensuring that each protocol was used appropriately for its intended purpose. This improvement can help reduce the risk of heparin medication errors and promote better patient outcomes.

A total of 12 nurses were involved in the incorrect calculation of heparin bolus doses and infusion rate changes, resulting in medication errors. These 12 nurses, who were responsible for the administration and including the double-check process, unfortunately, did not catch the heparin medication errors.

Based on interview and record review, the facility failed to ensure a well-organized surgical services department, in accordance with acceptable standards of practice when:

1. The Operating Room Director (ORD) was unable to set-up or operate the cell saver device (a medical device that recovers blood lost during surgeries that pose a high-risk for blood loss, and reinfuses into the patient), when the facility's Operating Room (OR) nursing staff required immediate assistance with cell saver set-up for Patient 9's aorticbiliac bypass procedure (a surgery that redirects blood flow around a large blocked artery in the groin or abdomen). As a result, the facility's contracted perfusionist (PERF, a contracted specialist who runs the heart-lung machine while patients are in open-heart surgery) had to be located in the facility, and requested to rapidly assist the OR nursing staff with cell saver set-up and operations (Refer to A-942, Finding 1).

2. The facility failed to ensure, that prior to surgery, one of two surgical patients' (Patient 9) medical record contained a medical doctor (MD) order to properly execute an informed surgical consent and an MD attestation related to a discussion with the patient, or family, of the risks, benefits, alternatives and complications of the surgical procedures to be performed. As a result, Patient 9 was transported to the facility's OR, and administered anesthesia, prior to MD 4 conducting an in-person surgical consultation with Patient 1, confirming Patient 1's exact surgical procedure, or generating an MD order for a properly executed surgical consent. This failure resulted in the potential for Patient 9 to be misinformed on the exact surgical procedure the surgeon intended to perform, and the risks, benefits, and alternatives to the procedure (Refer to A-955).

3. The facility's ORD was unable to provide direct surgical nursing services to patients receiving cardiovascular surgeries. As a result, the ORD was unable to provide nursing service relief, or support, to the cardiovascular OR (CVOR) nursing staff (Refer to A-942, Finding 2).

4. The facility failed to ensure that the scope of surgical services was staffed and organized to ensure that surgical personnel reported to qualified surgical clinical supervisors with knowledge and expertise in surgical service operations. (Refer to A- 941)

The cumulative effects of these systemic problems resulted in the failure of the facility to ensure the provision of safe surgical services to patients in the hospital.

Based on observation, staff interviews and record reviews, the facility failed to ensure that the scope of surgical services was staffed and organized to ensure that surgical personnel reported to qualified surgical clinical supervisors with knowledge and expertise in surgical service operations.

This failure had the potential to compromise the quality of nursing services delivered to all surgical patients, and result in adverse patient outcomes.

Findings:

A review of the facility's document titled, "Provision of Patient Care Manual- Operating Room", dated 10/23, indicated the facility's Operating Room (OR) provided surgical nursing care 24 hours a day, seven (7) days a week to surgical patients and consisted of six (6) general surgery operating rooms and one (1) CVOR on the second floor. The CVOR (cardiovascular OR) was available and staffed 24 hours a day seven (7) days a week for the open-heart program and will be included in the three (3) or four (4) rooms used for surgery. Surgical procedures were performed in the following specialties with appropriate equipment available for procedures: General Surgery ,Orthopedics, Ear Nose and Throat, Plastics, Cardiovascular, Neuro & Ortho Spine, Podiatry, Urology,Thoracic, Gynecology, and da Vinci Robotic Surgery. The department is staffed with the Director of Perioperative Services, OR Supervisor, Clinical Supervisors, Registered Nurses, Relief Clinical Supervisors, Scheduler/Billers, Surgical Scrub Technicians, Bio-Med/Equipment/Anesthesia Tech, OR Attendants, and Case Facilitator.

A review of the facility's document titled, "Job Description Nursing Director Surgical Services", dated 1/2014, indicated that the "Director of Surgical Services was responsible for direction of patient care in the operative environment." Requirements for this position include, "At least 2 years experience in Surgical Nursing," and "Current Certified Nurse OR (CNOR) (AORN) certificate(s) upon hire, preferred." (AORN, Association of Operating Room Nurses). The job description's Performance Accountability Section indicated ..."2. Performs all aspects of care in an environment that optimizes patient safety and reduces the likelihood of medical/health errors..."

A review of the facility's document titled, "Job Description Clinical Supervisor OR", revised 1/2018, indicated that the OR Clinical Supervisor (ORCS) reported to the facility's Nursing Director of Surgical Services. The Clinical Supervisor job summary indicated that ..."The clinical supervisor prepares, conducts, and/or oversees department(s) orientation and training of personnel....was responsible and accountable for the quality of staff and function during their shift. Assists the Department Director in the daily operation of the unit, directing, supervising, and evaluating personnel....The Clinical Supervisor's knowledge and accountability requirements included..."Recognizes, evaluates, and responds appropriately to operational emergencies or unusual situations...Leadership responsibility and accountability was to ensure quality patient care and unit operations in the department..." The Job Duties and Responsibilities indicated that when the Clinical Supervisor was in charge they served as a resource to staff in their area of expertise.

During a concurrent interview and record review, on 2/28/24, at 11:00 am , the facility's Human Resource Generalist (HR) stated that RN 20 was hired as the facility's ORCS on 10/25/23 and received her RN license on 1/01/1972. RN 20 had not worked as a Registered nurse since 11/2011. RN 20's prior nursing experience included work an outpatient medical clinic from 1/2004 - 11/2011, and managing local "Surgery Center," a small ambulatory surgery center with 2 ORs, from 2002 - 2004. RN 20's resume did not include any perioperative nursing experience in the last 22 years.

A review of a document titled the facility's "Perioperative Services Department Orientation List", dated 10/25/23, indicated that the purpose of the checklist was to provide new employees with an orientation to the OR to promote consistency and quality patient care and to acquaint the employee with the environment. The document indicated that "this form should be completed before access to the OR and kept in a file in the OR education office." The Orientation packet further indicated that RN 20, who was hired and operating as the facility's ORCS, did not receive training, or have proof of validated competencies, in the following perioperative areas:

1. End of case Process (processes in end of case completion)
2. Electrosurigcal Safety (safe use and operation of the Electrosurigcal unit)
3. Marking the surgical site procedure (knowledge requirements for marking of the surgical site)
4. Opening Sterile Supplies,
5. Patient Identification
6. Patient positioning (competency for positioning the surgical patient)- needs improvement,
7. Pyxis System (competency in operating the Pyxis system to obtain OR medication and narcotics)
8. Skin Preparation (preoperative hair removal with clippers and surgical skin preparation,
9. Specimen (handling of surgical specimens)
10. Sterile Processing/ Decontamination Room
11. Surgical Safety Checklist
12. Surgical Sharps Management
13. Time Out process
14. Tourniquet (use of pneumatic tourniquet)
15. Verification of Surgical Site, and
16. Wound classification.

During an interview on 2/26/24, at 3:00 pm, OR Scrub Technician (ORST) 1 reported that the current ORCS, RN 20, had been the facility's ORCS for several months and had continued difficulty with basic nursing skills. ORST 1 stated that RN 20 had no recent nursing experience, and was not up to speed with OR flow or practice. ORST 1 stated that RN 20 had transported surgical patients to incorrect OR rooms, made errors in verifying surgical consents, and was not confident assisting in the OR during surgery. ORST 1 stated since the facility frequently employed OR nurse travelers (RNs who accept a temporary assignment in a facility that is severely short staffed), it was important that the facility's ORCS was a skilled expert in OR nursing, to ensure the travelers understood the facility's nursing practice before they "hit the ground running." ORST 1 stated there was no sense of leadership in the surgical services unit because RN 20 did not have any OR experience to gain respect or leadership.

During an interview on 2/26/24, at 4:24 pm, RN 17 reported that the ORCS, RN 20, came out of retirement and had not worked in the health care industry for 13 years. RN 17 stated that ORCS, RN 20 had no idea how to deliver fundamental nursing services in the OR. ORCS, RN 20 could not assist with arterial line placement, circulating the OR (when a nurse assists the surgeon and OR team), or set-up or break down of an OR after use. RN 17 stated since the facility did not have a strong OR leader, various OR nurses attempted to "take over " and change the facility's nursing processes.

During a telephone interview on 2/26/24, at 6:46 pm, RN 18 stated she had 7 years experience as a CVOR nurse and was hired to work in the facility's CVOR as a traveler. RN 18 stated that the ORD relied on her to orient new OR RNs, and that the ORD requested for RN 18 to train RN 20. RN 18 declined to train RN 20 because RN 20 hadn't worked as an OR nurse for approximately 20 years and lacked the basic building blocks of OR nursing. RN 18 stated that RN 20 was unsafe working in the facility's OR.

During an interview with 2/27/24, at 5:36 pm, MD 3 stated that the ORCS, RN 20 was incompetent in OR nursing, and was only being utilized to run the the OR board ( a posting of the daily OR patient schedule). MD 3 reported that he observed the ORCS receiving supervision from the OR nursing staff versus providing nursing supervision. MD 3 stated this was a very dangerous dynamic because the facility's ORCS and ORD did not have the knowledge or experience to identify poor nursing practice.

During an interview on 2/28/24, at 9:11 am, Certified Nursing Assistant (CNA) 1 stated that RN 20, the facility's new ORCS, was unable to work independently and needed constant support from all of the OR staff. CNA 1 reported RN 20 continually requested assistance trying to locate different instruments for the surgeons and OR staff. CNA 1 reported he had to remind RN 20 of the same surgical instruments name and location multiple times. CNA 1 stated that although RN 20 was responsible for patient flow in the OR, he would assist her with transporting patients because she continually got confused on the patient's location in the facility.

During an interview on 2 /28/24, at 9:26 am, RN 21 stated that the ORCS, RN 20 did not know how to use the Pyxis (an automated medication dispensing system), despite being trained multiple times. RN 21 reported that she and RN 19 were orienting RN 20 on how to mix medications for ORSTs during surgery, however they stopped the orientation with RN 20 because she was having difficulty with the mathematics necessary to ensure medication safety.

During an interview on 2/28/24, at 1:07 pm, MD 2 stated that the ORCS, RN 20, was unable to follow the basic nursing processes required to correctly obtain a patient's surgical consent prior to transporting the patient to the OR (Refer to A - 955) .

During an interview on 2/27/24, at 11:48 am, ORD reported that she hired RN 20 for the ORCS position because she met the minimum job description requirements and had a history of OR nursing experience. ORD verified that RN 20's OR Orientation Checklist was incomplete and missing several dates and signatures that validated RN 20's OR nursing competencies. ORD stated she had received some staff complaints regarding RN 20's job performance and OR nursing skills, but ORD felt that those comments were based off of ageism and not RN 20's job performance. ORD reported that RN 20 had not displayed any "direct incompetence", but that RN 20 did have "room to grow." ORD acknowledged that the facility's job description required the ORCS to provide expertise and support to the OR staff. ORD stated that she depended on her more experienced OR nurses to provide expertise and support to the OR staff while RN 20 developed into her ORCS role, which was a process that did not align with the facility's organizational structure, chain of command, or surgical services provision of care policy.

During an interview on 2/29/23, at 1:30 pm, the Chief Nursing Officer (CNO) stated the expectation of the ORCS role was that the nurse be experienced and proficient in delivering OR nursing care, circulate OR cases when needed, assist with OR room turnovers, and run the OR board. CNO stated that it was his expectations that the ORCS be proficient and competent in OR nursing to assist with supervising and managing the team.

Based on interview and record review, the facility failed to ensure that prior to surgery, one of two surgical patients' (Patient 9) medical record contained a medical doctor (MD) order to properly execute an informed surgical consent and an MD attestation related to a discussion with the patient, or family, of the risks, benefits, alternatives and complications of the surgical procedures to be performed. As a result, Patient 9 was transported to the facility's operating room (OR), and administered anesthesia, prior to MD 4 conducting an in-person surgical consultation with Patient 1, confirming Patient 1's exact surgical procedure, or generating an MD order for a properly executed surgical consent.

This failure resulted in the potential for Patient 9 to be misinformed on the surgical procedure the surgeon intended to perform, and the risks, benefits, and alternatives to the procedure.


Findings:

A review of the facility's policy titled, "Decision Making: Consent Requirements for Medical Treatment," dated 2/2024, indicated that the policy's purpose was to facilitate a consent process that reflects good practice, contributes to patient safety, and is in compliance with applicable legislation. The policy's procedure indicated that "1. The physician performing the procedure and/or anesthesia/sedation is responsible to give the patient risks, benefits, and/or alternatives for the procedure.. which is necessary for the patient to make an informed consent decision....4.2 Consent form documentation. Name of specific treatment/procedure(s) filled in as physician ordered."

A review of the facility's policy titled, "Consents-Preoperative Services", dated 4/2020, indicated that the policy's purpose was to establish guidelines for consents. The policy's procedure indicated that ..."2. Consent shall be obtained from the surgeon's order sheet, verbal order, or from the history and physical plan of care..."

A review of a History and Physical, dated 2/25/24, at 11:31 pm, indicated that Patient 9 presented to the facility's Emergency Department (ED) on 2/25/24, with complaints of a slight hardening of upper abdomen and purulent discharge from a previous surgical wound from a recent laparoscopic partial colectomy (the surgical removal of diseased colon). Patient 9 was subsequently admitted to the facility, and was awaiting a surgical and interventional radiology consult for abdominal wound draining on 2/26/24. The History and Physical did not indicate the exact surgical procedure Patient 9 was scheduled for, or the risks, benefits, and/or alternatives related to the surgical procedure.

A review of the Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures, dated 2/26/24, indicated that Patient 9 consented on 2/26/24, at 4:59 pm, for MD 4 to perform an "Incision and drainage abdominal abcess; possible wound vac placement." The consent was co-signed, and witnessed, by Registered Nurse (RN) 33.

A review of the Anesthesia Record, dated 2/26/24, indicated that Patient 9 was transported to the OR 1, at 5:10 pm, and administered intravenous versed (a sedative that helps patients feel relaxed and sleepy before surgery) at 5:10 pm.

A review of Progress Notes, dated 2/26/24, at 5:29 pm, indicated that MD 4 consulted with Patient 9, confirmed the intended surgical procedure, discussed the surgical procedure's.. "risks, benefits, and alternatives..." , and obtained informed consent, 19 minutes after Patient 9 received sedation in OR 1.

A review of an MD Order for Surgical Consent, dated 2/26/24, at 5:30 pm, indicated that MD 4 generated an MD order detailing the exact planned surgical procedure to be performed that was to be transcribed on Patient 9's surgical consent prior to patient signature, 31 minutes after Patient 9 signed the nurse generated "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures document."

During a concurrent record review and interview, on 2/27/24, at 3:50 pm, the OR Director (ORD) and Director of Performance Improvement (DPI) verified that MD 4 did not generate a surgical consent order, or conduct a surgical consultation, until after Patient 9 was transported to the OR and administered sedation.

During an interview on 2/28/24, at 12:37 pm, OR Scrub Technician (ORST, a technician whose primary duties include preparing the operating room before surgery and working closely with the surgical team) 2 verified he was the ORST that assisted MD 4 with Patient 9's surgery. ORST 2 stated that the OR Clinical Supervisor (ORCS, a RN who supervises the OR staff), RN 20, advised the OR team that MD 4 was on site in the facility, had seen Patient 9, and was "ready for the patient to go" to OR 1. ORST 2 stated when MD 4 entered OR 1, he was upset that Patient 9 was already transported to the OR, and administered sedation, because he hadn't seen Patient 9 to conduct a surgeon consult, generate an MD order for surgical consent, or mark Patient 9's surgical site.

During an interview on 2/28/24, at 1:07 pm, MD 2, the anesthesiologist for Patient 9's case, stated that the ORCS, RN 20, informed the OR team that MD 4 was onsite, had conducted a face-to-face MD visit with Patient 9, and was ready to proceed to the OR. MD 2 reported that he had covered his portion of the anesthesia informed consent, and verified that the surgical consent was signed and dated, because he had assumed nursing staff were operating off of MD orders.

During an interview on 2/28/24, at 8:12 am, the ORCS, RN 20, stated that standard of practice, and facility policy, was that surgical consents were generated directly from an MD order. ORCS reported on 2/26/24, she spoke with Patient 9's surgeon, MD 4, earlier in the day to confirm that surgery was "a go", but she did not receive a verbal order for the surgical consent, nor did she document a verbal order for surgical consent in Patient 9's medical record. ORCS stated she could not recall if she filled out the "surgical procedure to be performed" on Patient 9's surgical consent, despite acknowledging that this portion should only be transcribed directly from an MD order. ORCS confirmed that she notified the OR staff, and MD 2, that Patient 9 was "good to go" to the OR. ORCS reported that this statement was referencing that MD 4 confirmed surgery was still "a go", and not a confirmation that all of the preoperative procedures had been completed.

During an interview on 2/27/24, at 3:30 pm, ORD stated that transporting a patient to the OR to begin a surgical procedure, without an MD ordered surgical consent or an MD consultation, was a serious nursing process violation. ORD reported that the facility's policy, and her expectations, were that surgical consents are always generated from MD orders and transcribed "word for word, without abbreviations, with every work spelled out." ORD reported that nursing staff should not transport a patient to the OR prior to a surgeon "getting eyes on patient, confirming the surgical procedure, and getting informed consent from the patient." ORD stated she had serious concerns of a break in policy because these are basic OR nursing processes.

During a telephone interview on 2/27/24, at 4:40 pm, MD 4 reported that when he entered the facility he was surprised that Patient 9 was already taken to OR 1 and sedated. MD 4 stated he had not conducted a face-to-face consultation with Patient 9, had not solidified the exact surgical procedure to be performed, and had not generated an order for a surgical consent prior to Patient 9 being transported to OR 1 and sedated. MD 4 stated that, luckily, he had a telephone consult with Patient 9 earlier in the day to discuss his anticipated plan for surgery and the procedure's risks and benefits, however the facility nursing staff were not aware of this, and should not have transported Patient 9 to the OR until they verified that these components were completed and correct. MD 4 stated he had concerns with this "major break in protocol", especially since the OR nursing staff generated a surgical consent off of "assumptions" and not MD order.