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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Emergency Services was out of compliance.

C-0880 The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients.

Based on interviews and document review, the facility failed to ensure staff had demonstrated training and competency to provide the administration of moderate sedation and monitor patients receiving moderate sedation in one of one medical record reviewed of a patient receiving moderate sedation (Patient #1).

Findings include:

Facility policy:

Upon request, the facility was unable to provide a written policy and procedure providing guidance on moderate sedation.

References:

The facility stated it followed Lippincott's procedures for nursing guidelines. According to the Lippincott's Procedures for Moderate Sedation, provided by the facility on 12/29/22, moderate sedation is a drug-induced depression of consciousness in which the patient responds purposefully to verbal commands, either spontaneously or with light tactile stimulation. With moderate sedation, the patient is able to maintain a patent airway, protective reflexes (such as the ability to handle secretions with aspiration), adequate spontaneous ventilations, and cardiovascular function without interventions. Moderate sedation, or procedural sedation and analgesia, is commonly administered to relieve anxiety, discomfort, or pain so that patients can tolerate unpleasant procedures in children and uncooperative adults, it may be used to expedite procedures that aren't particularly uncomfortable but that require the patient to remain still. Because predicting a patient's response to sedation isn't always possible, health care providers must have an understanding of the different levels of sedations.

In addition to the person administering moderate sedation, this procedure requires the presence of at least one other person capable of establishing a patent airway, administering positive-pressure ventilation to the patient, and summoning additional assistance if necessary. A patient receiving moderate sedation requires sedation monitoring before the procedure, throughout the procedure, and during the recovery period. Health care workers permitted by their scope of practice to administer moderate sedation should receive special training. Those administering the sedation who are responsible for the patient's care should understand the pharmacology of the agents as well as the role of reversal agents. Those monitoring the patient receiving moderate sedation should be able to recognize associated complications.

Moderate sedation is commonly administered for procedures that are performed in many settings outside the operating room. Regardless of the location, adequately trained staff and appropriate monitoring equipment must be available to ensure the patient's safety.

The Medical Staff Bylaws read, The medical staff will actively participate in the review of clinical work being performed and include: a. Medication therapy, b. Infection control (including community and hospital acquired infections inpatients and health service workers), c. Surgical and invasive procedures - including tissue and non-tissue producing cases with and without anesthesia and/or conscious sedation.

1. The facility failed to ensure staff had demonstrated training and competency to provide the administration of moderate sedation and monitor patients receiving moderate sedation.

A. Medical record review

i. A review of Patient #1's medical record revealed the patient was treated in the emergency room (ER) on 10/22/22 for a shoulder dislocation confirmed by x-ray imaging. Review revealed Physician #2 attempted to reduce (a technique used to return the shoulder to its normal placement) the dislocation multiple times during the visit without success. In a note, Physician #2 documented she had consulted with an orthopedic surgeon and subsequently ordered intravenous (IV) morphine sulfate (an opiate narcotic) and intravenous midazolam (a sedative) in order to assist in allowing Patient #1 to be sedated enough for another attempt at shoulder reduction to be successful. Administrations of these medications were documented as follows: 9:14 p.m. 0.5 mg morphine IV, 9:35 p.m. 1 mg midazolam and 0.5 mg morphine IV, and 9:57 p.m. 1 mg morphine IV by a registered nurse. Record review revealed the last shoulder reduction attempt was also unsuccessful and Patient #1 was transferred via ambulance to an outside facility.

B. Interviews

i. An interview was conducted with registered nurse (RN) #5 on 12/28/22 at 3:30 p.m. RN #5 stated she had never done a moderate sedation in this facility before and stated she did not recall sedation being part of her orientation or clinical competencies.

ii. An interview was conducted with RN #6 on 12/29/22 at 2:46 p.m. RN #6 stated she had been a part of two moderate sedation procedures conducted at the facility. RN #6 further stated she was with the director of nursing (DON) for these moderate sedation procedures and the DON provided her training and orientation on how to do moderate sedation during the procedures. She stated she did not recall receiving training or completed a moderate sedation competency prior to these sedation procedures occurring.

A review of six personnel files of nurses who worked in the emergency room (ER) revealed no specific competencies or training for moderate sedation administration or patient monitoring. This personnel file review included the RN who administered moderate sedation medications and monitored Patient #1.

iii. An interview was conducted with the chief nursing officer (CNO) #1 on 12/29/22 at 9:56 a.m. CNO #1 stated the common medications used at the facility for moderate sedation were fentanyl (an opiate narcotic) and midazolam (a benzodiazepine medication used as a sedative) together, or ketamine (a medication used to provide anesthesia and pain relief), or less often, IV morphine (an opiate narcotic) and IV midazolam together. She stated giving IV morphine and midazolam together was considered moderate sedation and this patient would require continuous monitoring with pulse oximetry (device used to measure the amount of oxygen in the blood), breathing rate, blood pressure and heart rate and rhythm and would require a nurse to be with the patient at all times.

CNO #1 further stated not all nurses at the facility were trained in administering moderate sedation medications or monitoring a patient receiving moderate sedation and stated moderate sedation training was not part of orientation or required competencies for nurses at the facility. CNO #1 stated the facility did not have a policy or procedure for administering or monitoring for moderate sedation. She further stated there was a concern with staff conducting moderate sedation procedures without specific training. CNO #1 stated there was potential risk to patients receiving moderate sedation if staff did not know how to monitor these patients and the risk was that a patient could be under or over medicated, or could experience respiratory failure or cardiac failure.

iv. An interview was conducted with the director of nursing and trauma coordinator (DON) #7 on 12/29/22 at 3:15 p.m. DON #7 stated moderate sedation was used for procedures which might be painful or require a patient to be sedated or lay still such as laceration repairs or orthopedic dislocations. DON #7 further stated the facility did moderate sedations infrequently, about once per year on average. She explained the medications used for moderate sedation at the facility were most commonly fentanyl and midazolam together, ketamine intranasally (by inhaling through the nose) or less commonly morphine and midazolam. She stated the risk to patients in receiving these medications was potential for an allergic reaction, respiratory depression, bradycardia (slow heart rate) and other heart rate abnormalities or cardiac arrest. She stated the risk to a patient receiving moderate sedation by a nurse or physician who was not trained or prepared was not knowing what to watch for and the patient experiencing respiratory distress or failure.

DON #7 further stated she organized training days throughout the year for staff to learn skills such as moderate sedation, stroke alerts, cardiac emergencies, and further stated the importance of the skills days were for staff to gain knowledge and practice to be prepared for what to do and how to handle different emergencies or conditions that could come into the ER. She stated there had been an orthopedic dislocations and sedations skills training held in July of the past year, but it was not a required training for all providers or nurses who worked in the ER.

A review of the attendance for the orthopedic dislocations and sedations training conducted on 7/27/22 revealed of the staff who conducted sedations at the facility, only Physician #3 and three nurses attended the training.

v. An interview was conducted with the medical chief of staff (Physician) #3 on 12/29/22 at 12:21 p.m. Physician #3 stated moderate sedations were done rarely in the facility under the circumstance when a patient needed to be sedated such as a child who needed sutures placed or for shoulder reductions. He stated none of the physicians at the facility were emergency medicine trained, but stated all providers at the facility had worked in emergency departments in the past, and all providers at the facility had performed moderate sedations in their previous facilities.

Physician #3 stated it was important for patients receiving moderate sedation to be monitored for cardiac, respiratory, arousal and neurological statuses to ensure patients were not being overly sedated. He further stated the risks to patients receiving moderate sedation could be respiratory distress and a drop in blood pressure or heart rate which could require emergency intervention. Physician #3 explained because of the risks, during a moderate sedation a nurse trained to respond to respiratory and cardiac emergencies would stay with the patient the entire time and continuously monitor the patient's respiratory, cardiac and neurological status.

Physician #3 stated he had prior experience performing moderate sedations at the previous facility he worked at. He further stated as the medical chief of staff, it was his role to review the clinical credentials of providers who applied to work at the facility or applied for a reappointment to continue working at the facility. He further stated it depended on an individual provider's comfort level on whether providers were deemed competent to provide moderate sedation to patients in the ER. He further stated there was not a specific training or competency required or a specific privilege granted for moderate sedation administration at the facility and he was not aware of whether the medical bylaws included specific privileges regarding sedation. Physician #3 further stated it was important from a patient safety standpoint to ensure staff were competent and trained to administer and monitor patients undergoing moderate sedation. He stated a patient could experience respiratory distress or a drop in blood pressure and go into organ failure or be killed if moderate sedation was not administered and monitored properly.

A review of Physician #3's credential file did not reveal any specific moderate sedation training or experience or specific privileges granted to perform moderate sedation.

vi. An interview was conducted with Physician #2 on 12/30/22 at 11:30 a.m. Physician #2 stated she recalled having performed two moderate sedations at the facility for procedures, one for a pediatric suture placement and another one for the shoulder dislocation for Patient #1 on 10/22/22. She stated for procedures requiring sedation, she would start with oral midazolam or lorazepam (a benzodiazepine medication used as a sedative) first and see if it would provide enough sedation to complete the procedure. Physician #2 stated if oral midazolam did not cause sufficient sedation, then intranasal ketamine might be administered, or a narcotic and a sedative such as fentanyl and midazolam or morphine and midazolam. Physician #2 stated risks to a patient who underwent moderate sedation included excessive agitation, abnormal behaviors, allergic reaction, low blood pressure or heart rate abnormalities (too low or two high), and respiratory distress. She stated due to those risks, it was necessary for the patient to have IV access in case emergency medications were required and it was necessary for the patient to be closely monitored on a cardiac respiratory monitor and pulse oximetry.

Physician #2 stated she had worked in an urgent care in her previous facility where moderate sedations were not done and stated she did not have experience performing moderate sedations prior to coming to the facility. She further stated she had not completed any specific training on how to conduct moderate sedation at the facility and stated she did not attend the moderate sedation and skills class that occurred in July and recalled having been out of town. Physician #2 stated she did not know whether moderate sedation was specifically on the list of granted privileges for providers who practiced at the facility. Physician #2 stated the risk to a patient of a provider who did not have previous experience or training performing sedations was that a patient could have a drop in blood pressure, or could go into respiratory arrest or cardiac arrest.

A review of Physician #2's credential file did not reveal any specific moderate sedation training or experience or specific privileges granted to perform moderate sedation.

vii. An interview was conducted with the chief executive officer (CEO) #8. CEO #8 stated the medical chief of staff was responsible to review credential applications for medical providers and determine if providers met the clinical competency requirement of the medical bylaws. He further stated after the medical chief of staff reviewed the credentialing packet for providers, he as the CEO would review the credentialing packet and then it would go before the facility's governing board. CEO #3 stated the governing board had ultimate fiduciary responsibility and were the body responsible for granting medical appointments and clinical privileges to providers to practice at the facility based on the provider's training and competency. CEO #3 stated that for clinical experience and credentials, he relied on the chief of staff to determine what was deemed clinically competent for providers. CEO #3 stated he was not aware that moderate sedation privileges were not specifically mentioned in the core privileges or special privileges which were granted to providers by the governing board. He stated ultimately the authority of which clinical privileges were granted to providers rested on the governing board.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.638 Clinical Records was out of compliance.

C-1118 Dated signatures of the doctor of medicine or osteopathy or other health care professional. Based on document review and interviews, the facility failed to ensure verbal orders included dated signatures of a doctor of medicine or osteopathy or other health care professional in six of eight records reviewed (Patients #1, 3, 4, 6, 7, and 8).

Based on document review and interviews, the facility failed to ensure verbal orders included dated signatures of a doctor of medicine or osteopathy or other health care professional in six of eight records reviewed (Patients #1, 3, 4, 6, 7, and 8).

Findings include:

Reference:

The Medical Staff Bylaws read, verbal orders (either in person, via telephone or by facsimile transmission) for medication or treatment shall be accepted when it is impractical for such orders to be given personally in a written manner by the responsible medical staff member. The order shall include the date and signature of the person taking the order and shall be countersigned as soon as possible by the prescribing practitioner.

1. The facility failed to ensure verbal orders were countersigned by the ordering physician, physician's assistant or nurse practitioner for patients admitted to the facility's acute care unit, extended care unit, and in the emergency room.

A. Document review

i. A review of the medical records of Patients #1, 3, 4, 6, 7, and 8 was conducted. The review revealed verbal orders were not countersigned by the provider (physician, nurse practitioner, or physician's assistant) who originated the order. The review was conducted on paper medical records, and the lack of a countersignature from a provider was confirmed in the electronic medical record. For example:

a. Review of Patient #1's medical record revealed he had presented to the emergency room (ER) on 10/22/22 and was discharged from the ER on 10/23/22. Patient #1's medical record included multiple unsigned verbal orders. For example, on 10/22/22 at 7:29 p.m., nursing staff placed a verbal order for a one milligram (mg) morphine intramuscular (IM) injection (opioid pain medication to be injected into a large muscle). On 10/22/22 at 9:32 p.m., nursing staff placed a verbal order for an x-ray of the patient's left shoulder. On 10/22/22 at 10:32 p.m., nursing staff placed a verbal order for morphine intravenous (IV) push 1 mg once (opioid pain medication to be injected into the patient's vein). There was no indication in the medical record that these orders had been countersigned by a provider.

b. Review of Patient #3's medical record revealed he was admitted to the acute care unit on 7/1/22 and was discharged from the extended care unit on 11/19/22. Patient #3's medical record included multiple unsigned verbal lab orders. For example, on 11/19/22 at 7:50 a.m., nursing staff placed a verbal order for a liver function panel (a blood test that helps determine how well the patient's liver is functioning). There was no indication in the medical record that this order had been countersigned by a provider.

c. Review of Patient #4's medical record revealed she was admitted to the acute care unit on 10/19/22 and was transferred to a different facility on 10/21/22. Patient #4's medical record included multiple unsigned verbal orders. For example, on 10/21/22 at 1:06 a.m., nursing staff placed a verbal order for DuoNebs 3 mg QID prn dyspnea (an inhaled medication that should be taken four times a day, but only as needed when the patient experiences shortness of breath). On 10/21/22 at 2:37 a.m., nursing staff placed an order for a regular diet (a diet with no special modifications for food type or texture). On 10/21/22 at 6:27 a.m., nursing staff placed a verbal order for an electrocardiogram (an electrical tracing of the heart's rhythm) due to the patient having a fast heart rate. There was no indication in the medical record that these orders had been countersigned by a provider.

Further examples of verbal orders missing countersignatures were found in the medical records of Patients #6, 7, and 8.

These findings in the medical records of Patients #1, 3, 4, 6, 7, and 8 were in contrast to the Medical Staff Bylaws, which read verbal orders (either in person, via telephone or by facsimile transmission) for medication or treatment should have been accepted only when it was impractical for such orders to have been given personally in a written manner by the responsible provider. The order should have included the date and signature of the person taking the order and should have been countersigned as soon as possible by the prescribing provider.

B. Interviews

i. On 12/29/22 at 9:56 a.m., an interview was conducted with chief nursing officer (CNO) #1. CNO #1 stated the facility expected verbal orders to be used as infrequently as possible, as providers had remote access to the electronic medical record (EMR). She further stated after staff placed a verbal order in the EMR, the system would send the order to the provider for a countersignature. CNO #1 said the facility did not currently have any medical record audits on verbal orders outside of the billing and coding department, and that there was not a specific facility policy referring to verbal orders.

CNO #1 explained it was important for providers to countersign verbal orders, as the countersignature confirmed the order accurately reflected the provider's intentions for medical treatment. She further explained if an order was placed inaccurately there was a risk the patient's treatment would not have been what the provider had intended.

ii. On 12/29/22 at 12:21 p.m., an interview was conducted with the medical chief of staff (Physician) #3. Physician #3 stated his expectation was that providers entered orders themselves to avoid ambiguity in the ordering process. Physician #3 explained the EMR would notify providers of verbal orders needing signatures only if the provider had the patient's specific medical record open. He further explained the facility had a system where staff working in medical records or coding would call or email providers if a verbal order needed a signature. Physician #3 stated the EMR would not allow a patient to be discharged if verbal orders were not countersigned by a provider. This was in contrast with the medical record review of patients who were discharged yet still had missing countersignatures of verbal orders by the provider.

Physician #3 stated it was important for providers to countersign orders to ensure the orders were not being placed by unauthorized staff. Physician #3 further stated countersigning orders indicated the provider agreed with the order, and that ultimate responsibility for orders stopped with the providers.

iii. On 12/30/2022 at 10:53 a.m., an interview was conducted with revenue cycle director (Director) #4. Director #4 stated after she conducted an investigation, it became clear the staff's belief the EMR would not allow a medical record to be closed with unsigned verbal orders was inaccurate. She stated the EMR did have a warning if a signature was needed on an order, but the medical record could still have been closed with the warning in place. Director #4 stated it was important that providers signed verbal orders as it indicated the provider approved of the order. She explained without a signed verbal order, a patient could have been billed for a procedure that was not indicated or approved by the provider. Director #4 further explained signed orders indicated patients received the care they needed.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.641 Quality Assessment and Performance Improvement Programs was out of compliance.

C-334 The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year and includes review of The CAH'S health care policies. Based on document review and interviews, the facility failed to perform an annual review in nine of ten policies reviewed.

Based on document review and interviews, the facility failed to perform an annual review in nine of ten policies reviewed.

Findings include:

Facility policy:

The Policy Committee policy read, a multidisciplinary policy committee will be established as set forth by CMS regulation and will be comprised of, but not limited to, at least one physician to provide clinical guidance and expertise to attend at least one meeting annually, a member of the community to attend at least one meeting annually, and an employee to represent knowledge of nursing operations. The Chairman of the committee may add and remove members as needed. The involvement of non-committee members may be required on an as-needed basis.

The policy committee will be responsible to meet for review and approval of all facility policies at least annually. The committee will meet otherwise as needed as new policies are submitted.

1. The facility failed to ensure an annual review or update of policies was maintained in accordance with facility policy.

A. Document review

i. On 12/29/22, ten facility policies were randomly selected for a review of the dates the policies were effective or reviewed. Nine of the ten policies had effective or reviewed on dates older than one year. For example:

a. The Incident Reporting policy was effective on 4/19/16 and had been last reviewed by the facility on 2/14/20.

b. The Policy Committee policy was effective on 10/7/15, and had been last reviewed by the facility on 2/14/20.

c. The Medical Emergencies policy lacked an effective date and a date of when it had been last reviewed.

d. The Non-Medical Emergencies policy lacked an effective date but included an approved date of 1/9/14, and had never been reviewed by the facility.

e. The review revealed similar findings in the Long Acting Opioids in the Emergency Department policy, the Staff Availability Policy, the Quality Assessment and Assurance Plan policy, the Medication Administration policy, and the Clinical Furnished Services policy.

These findings were in contrast to the Policy Committee policy, which required a multidisciplinary policy committee that should have met at least annually to review and approve all facility policies.

ii. Upon request the facility was unable to provide meeting minutes for any 2022 policy committee meetings.

B. Interviews

i. On 12/28/22 at 3:30 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated policies provided a guideline so that all staff members had the same understanding of facility expectations. RN #5 further stated policies were intended to eliminate grey areas and set a standard of care that protected medical personnel and patient safety by ensuring consistent processes. RN#5 explained consistent policies and processes allowed data collection so that the need for changes would be obvious, as the world of medicine was always changing.

ii. On 12/29/22 at 9:56 a.m., an interview was conducted with chief nursing officer (CNO) #1. CNO #1 stated policies were a reference to facility expectations and regulatory laws. CNO #1 said it was important for policies to have been updated so that staff would have had access to the most current, updated information.

CNO #1 explained a policy's effective date required a signature from members of the governing board and other appropriate personnel. She further explained if a policy had a reviewed date in the facility's online database, this indicated a manager or director had reviewed the policy but had not made any changes to the policy content. CNO #1 said if changes had been made to the policy, the effective date would have been changed and new signatures attached.

CNO#1 further explained the process for reviewing and updating policies had changed, as the individual responsible for the policy committee was no longer employed at the facility. Previously, human resources would send out a yearly reminder to review policies but this had not occurred recently. CNO #1 stated the policy committee had not been meeting. CNO #1 further stated the current process was to submit the policy to administrative staff through email, and the policy would then be discussed in a combination of online meetings and via email. CNO #1 explained the facility had many outdated policies waiting to be updated.

This interview was in contrast to the Policy Committee policy, which read a multidisciplinary policy committee should have been established as set forth by CMS regulation. The policy committee should have been comprised of, but not limited to, at least one physician to provide clinical guidance and expertise to attend at least one meeting annually, a member of the community to attend at least one meeting annually, and an employee to represent knowledge of nursing operations.