HospitalInspections.org

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

A. ensure radiologist that were performing procedures on site at the facility were credentialed to perform those procedures. Forty-five procedures were performed at the facility from 10-16-2018 to 9-12-2019 by radiologist that were not credentialed to perform interventions onsite at the facility.

B. ensure that an investigation was completed on all the cases performed by uncredentialed physicians to determine the outcomes from the procedures performed. The facility failed to follow their policy on investigating adverse events.

C. ensure that an occurrence report was filed and investigated for an adverse event on Patient #1. The facility failed to follow their policy on reporting occurrences.

D. ensure that a process was implemented to prevent uncredentialed practitioners from performing procedures at the facility.

E. ensure that staff was provided education on a process to prevent uncredentialed practitioners from performing procedures at the facility.

F. ensure that all nursing staff had current competencies prior to administering medications for moderate sedation. Four (Staff #'s 7,12 ,13, and 14) of five personnel records reviewed revealed nursing staff did not have current competencies for moderate sedation and had recently given sedation in the ED or the radiology department.

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients who were having an Interventional Radiology procedure or moderate sedation in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

G. ensure that nursing staff had a complete and accurate order prior to administering medications used to sedate patients during a procedure. Staff #7 gave Versed (benzodiazepine medication) and Fentanyl (narcotic pain medication) outside of the parameters in the written physician order for Patient #1.

H. ensure that a pre-sedation evaluation was done on patients receiving moderate sedation prior to the sedation. Patient #1 did not have a pre-sedation evaluation documented in the medical record prior to receiving moderate sedation. The facility failed to follow their policy on moderate sedation.


Cross Refer to Tag A 144

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

A. ensure radiologist that were performing procedures on site at the facility were credentialed to perform those procedures. Forty-five procedures were performed at the facility from 10-16-2018 to 9-12-2019 by radiologist that were not credentialed to perform interventions onsite at the facility.

B. ensure that an investigation was completed on all the cases performed by uncredentialed physicians to determine the outcomes from the procedures performed. The facility failed to follow their policy on investigating adverse events.

C. ensure that an occurrence report was filed and investigated for an adverse event on Patient #1. The facility failed to follow their policy on reporting occurrences.

D. ensure that a process was implemented to prevent uncredentialed practitioners from performing procedures at the facility.

E. ensure that staff was provided education on a process to prevent uncredentialed practitioners from performing procedures at the facility.

F. ensure that all nursing staff had current competencies prior to administering medications for moderate sedation. Four (Staff #'s 7, 12, 13, and 14) of five personnel records reviewed revealed nursing staff did not have current competencies for moderate sedation and had recently given sedation in the ED or the radiology department.

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients who were having an Interventional Radiology procedure or moderate sedation in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

G. ensure that nursing staff had a complete and accurate order prior to administering medications used to sedate patients during a procedure. Staff #7 gave Versed (benzodiazepine medication) and Fentanyl (narcotic pain medication) outside of the parameters in the written physician order for Patient #1.

H. ensure that a pre-sedation evaluation was done on patients receiving moderate sedation prior to the sedation. Patient #1 did not have a pre-sedation evaluation documented in the medical record prior to receiving moderate sedation. Also, the facility failed to follow their policy on moderate sedation.



Findings:

A. RADIOLOGIST PERFORMING PROCEDURES WITH NO ONSITE CREDENTIALS

Review of a log provided by the facility after entrance revealed that forty-five procedures were performed at the facility from 10-16-2018 to 9-12-2019 by radiologist (Staff #'s 8, 10, and 11) who were not credentialed to perform interventions onsite at the facility.

Staff #1 stated, the facility identified an issue with three radiologists (Staff #'s 8, 10, and 11) after Staff #8 requested to use moderate sedation on a CT guided abscess drainage he was performing. Staff #9 called Staff #2 to inquire if Staff #8 had moderate sedation privileges. It was then determined Staff #8 did not have any privileges for onsite procedures. At that point the procedure was put on hold and the patient was transported back to his room. Staff #16 signed and approved temporary privileges for Staff #8 on 9-12-2019. Patient #1 was brought back to radiology for procedure. Staff #6 was in the room to supervise moderate sedation during the procedure.

Following this incident, the facility identified 15 procedures performed by Staff #10 with no onsite privileges, 7 procedures performed by Staff #11 with no onsite privileges, and 23 procedures performed by Staff #8 with no onsite privileges.

Staff #'s 1 and 2 were asked what processes were put in place to prevent physicians from performing procedures at the facility who did not have any credentials to do so. Staff #2 stated, she had sent out email to the facility department directors on 9-12-2019 with instructions on how to check physician credentials. Staff #1 stated that he had several emails to and from IT department making sure that an app was placed on each desktop to check physician credentials. Staff #2 was asked if she had any return confirmation from the directors confirming they had completed training for their employees. Staff #2 confirmed she did not.

Interviews conducted on 10-3-2019 revealed the following:

Staff #17 was asked about any knowledge of physicians that were uncredentialed performing procedures in the facility. Staff #17 stated, "I only know of one. The incident occurred 9-12-2019. The physician (Staff #8) requested sedation in the procedure. The nurse called to check credentials for sedation and it was then determined Staff #8 did not have any on-site privileges".

Staff #18 was asked about any knowledge of physicians that were uncredentialed performing procedures in the facility. Staff #18 stated, "I was not personally involved in the procedure, but I did hear about one incident that involved Staff #8 in Cat Scan (CT) room."

Staff #19 was asked about any knowledge of physicians that were uncredentialed performing procedures in the facility. Staff #19 stated, "I know about one incident in CT room with Staff #8. I am not aware of any others.

As of 10-4-2019, Staff #'s 8, 10, and 11 did not have on site radiology privileges.

Review of the October 2019 Radiology schedule revealed Staff #11 was on the schedule for 10-8-2019. Staff #11 did not have any privileges to perform on site interventional procedures.

Review of the contract between the facility and the contracting radiology group revealed the following:

"Professional Qualifications: Contractor shall ensure all contractors representatives utilized to provide radiology services under this agreement continuously have and maintain the following credentials:

...2. Contractor's representative shall obtain and maintain appropriate medical staff privileges at the facility required to provide radiology services under this agreement in accordance with the facilities requirements and facilities Medical Staff Bylaws.


B. INVESTIGATION ON ALL CASES PERFORMED BY UNCREDENTIALED PHYSICIANS

An interview with Staff #2 on 10-3-2019, after 10:30 a.m., revealed the following:

Staff #2 was asked if the facility had initiated any investigation into the patients that had procedures performed on them by an uncredentialed physician to ensure there were no bad outcomes. Staff #2 confirmed they had not. Staff #2 stated, "Staff #3 did complete a gap analysis report on Patient #1 involving the CT incident."


An interview with Staff #3 on 10-3-2019, after 10:30 a.m., revealed the following:

Staff #3 was asked if risk management had initiated an investigation into the patients that had procedures performed on them by an uncredentialed physician to ensure there were no bad outcomes. Staff #3 confirmed she had not. Staff #3 stated, "I did complete a gap analysis on the incident involving Patient #1.


Review of the facility document titled, "Credentialing Issue Investigation and resolution plan" revealed no investigation of patient outcomes, nor did it include a review of Patient #1's medical record to include the incident in the CT room.

Review of the facility policy titled, "Adverse Events with last revision date of 5/2019 revealed the following:

"Procedure

1. Adverse patient (or non-patient in the event of rape or homicide) occurrences may be identified through occurrence reporting, chart reviews and other performance improvement activities, patient/significant other complaints and other sources. When a sentinel event occurs, the risk manager must be notified immediately. Front line staff may contact the department director or house supervisor to notify the risk manager or the staff may contact the risk manager directly.

2. An adverse which potentially meets the sentinel event or serious safety event definition should be reported to the risk manager. (In the absence of risk manager, it should be reported to the Quality Resource director or a member of the executive team who is a member of the quality/patient safety council). The risk manager shall notify the corporate risk manager of the adverse event ...

3. If the definition is or appears to be met, the risk manager or quality resource director will notify the Chief Executive Officer, Chief Nursing Officer, patient's attending physician, appropriate department managers, and others as deemed appropriate, that a root cause analysis needs to be initiated ...


C. OCCURRENCE REPORT

Review of the facility occurrence listing for 4-3-2019 to 10-1-2019 revealed the following:

There was no occurrence on the log for Patient #1. Staff #2 confirmed the finding.


An interview with Staff #2 on 10-3-2019 after 10:30 a.m. revealed the following:

Staff #2 was asked if anyone at the facility filed an occurrence report on Patient #1 following the incident in the CT Room. Staff #2 confirmed there was no incident on the log.


Review of the medical record for Patient #1 revealed the following:

Patient #1 was a 19-year-old male who presented to the emergency department (ED) with right lower quadrant pain for about a week. Found to have gangrenous appendicitis/abscess.

Review of the Consult history and physical note revealed the following:
" ...there is no indication for surgical exploration, but he does need IV antibiotics and consideration for the percutaneous drainage of the abscess ...We will discuss the case with our radiology colleagues tomorrow to see whether the abscess can be percutaneously drained ..."


Review of the admitting history and physical assessment and plan revealed the following:
"a percutaneous drainage recommended with intervention radiology, will attempt tomorrow ..."


Review of the post-operative progress note revealed the following:
"Procedure performed: failed RLQ abscess drain due to Pt. pain. 4 mg versed, and 200 mcg Fentanyl administered, and Pt. had no pain relief. Performed 18-gauge aspirate."


Review of the facility policy titled, "Occurrence Reports" with a revised date of 4/2015 revealed the following:

"Purpose:

1. To identify factors contributing to incidents or accidents ...

5. The occurrence report is to be used for any situation which is not considered consistent with routine operations of the hospital, its staff, or care of a patient or any situation which has potential to cause patient, visitor or employee injury ...


Policy:

All employees have an affirmative duty to report any occurrence which is not consistent with the routine operation of the hospital, its staff, or the routine care of a particular patient or visitor, or any situation which has potential to cause injury to patient, visitor or employee ..."


D. PROCESS ON CHECKING CREDENTIALS FOR PHYSICIANS

Staff # 2 was asked what processes were put in place to prevent physicians from performing procedures at the facility who did not have any credentials to do so. Staff #2 stated, she had sent out email to the facility department directors on 9-12-2019 with instructions on how to check physician credentials. Staff #1 stated that he had several emails to and from IT department making sure that an app was placed on each desktop. Staff #2 was asked if the facility had developed and implemented a process to prevent an occurrence of uncredentialed physicians working at the facility.

Staff #2 stated, "The facility told the staff that it is their responsibility to check the credentials of the physician they are working with prior to the procedure." Staff #2 was asked if anyone prior to the staff at the department level was responsible for checking the credentials. Staff #2 stated, "our credentialing secretary is now getting the radiology schedules to review, but ultimately the employees are responsible."


E. TRAINING ON CHECKING PHYSICIAN CREDENTIALS

Staff #2 was asked if the facility had completed any training for staff on how to check physician credentials. Staff #2 stated, she had sent out emails to the facility department directors on 9-12-2019 with instructions on how to check physician credentials. Staff #1 stated that he had several emails to and from IT department making sure that an app was placed on each desktop. Staff #2 was asked if she had any return confirmation from the directors confirming they had completed training for their employees. Staff #2 confirmed she did not.


Staff interviews on 10-3-2019 after 10:30 a.m. revealed the following:

Staff #17 was asked if she had received any training on how to check a physician's credentials. Staff #17 stated, "My co-worker showed me the credentialing tab on the desktop, but I am not very familiar with it." Staff #17 was asked if the radiology department receives the schedules in advance for the month. Staff #17 stated, "Yes, but they are usually not sent till after 1st week of the current month."

Staff #18 was asked if she had any training on how to check a physician's credentials. Staff #18 stated, "Nothing official. My co-worker showed me the icon on the desktop."

Staff #19 was asked if she had any training on how to check a physician's credentials. Staff #19 stated, "Staff #2 came down to the department and showed me the icon on the computer."

Staff #'s 20 & 21 both stated they were not aware of how to check any physician credentials. Staff #20 & 21 both stated as far as they knew, a physician on the schedule was credentialed and approved to perform a procedure.


F. NURSING COMPETENCIES

Review of personnel files with Staff #2 on 10-3-2019 revealed the following:

Four (Staff #'s 7, 12, 13, and 14) of five personnel records reviewed, nursing staff did not have current competencies for moderate sedation and had recently given sedation in the ED or the radiology department.

Staff #12 did not have any current competencies to administer moderate sedation. Staff #12 gave sedation for a procedure in the ED 9-20-2019, 13 days prior.

Staff #13 did not have any current competencies to administer moderate sedation. Staff #12 gave sedation for a procedure in the ED 9-27-2019, 6 days prior.

Staff #14 did not have any current competencies to administer moderate sedation. Staff #14 gave sedation for a procedure in the ED 9-20-2019, 13 days prior.

Staff #7 did not have any current competencies to administer moderate sedation. Staff #7 gave sedation for a procedure in the radiology department 9-12-2019, 21 days prior.

Staff #2 confirmed the findings on competencies.


Review of the facility policy titled, "Administration of Moderate Sedation by Non-Anesthesia Personnel" with a revision date of 1/2017 revealed the following:

PERSONNEL
1. Moderate Sedation can be administered by credentialed NAPP and nursing staff who have competency validation ...

COMPETENCIES
Nursing staff assisting with sedation administration will maintain the following:

...annual sedation competency ...


G. PHYSICIAN ORDERS

Review of Patient #1's medical record on 10-3-2019 with Staff #7 revealed the following:

Medication Administration documentation on 9-12-2019 during CT guided abscess drainage showed:

"Versed 1 mg was given Intravenous (IV) at 2:00 p.m., 2:14 p.m., and 3 p.m. for a total of 3 mg versed administered.

Fentanyl 50 mcg was given IV at 2:00 p.m., 2:14 p.m., and 3:08 p.m. for a total of 150 mcg total of Fentanyl given.


Review of the facility document titled, "Conscious sedation order sheet" revealed the following:

There was a physician order for versed 4 mg IVP (Intravenous push).

There was a physician order for Fentanyl 200 mcg IVP.

The order did not document if the order was a one-time dose, nor did it list any parameters for the nurse to follow administering the medications.


Staff #7 was asked to show surveyor the physician order for the medications administered. Staff #7 referred to the above referenced order with no parameters listed. Staff #7 was asked who made the determination on the dosage of the medication's given and the titration of the medication. Staff #7 stated, "The physician. I don't give any medication unless the physician orders it." Staff #7 was asked again to show the surveyor the order. Staff #7 confirmed there was no order with parameters listed.


Review of the facility document titled, "postoperative progress note" revealed the following:

Staff #8 documented that a total of 4 mg of versed and 200 mcg of Fentanyl were given during the procedure. This documentation did not correlate with the documentation by Staff #7, the nurse who administered the medication.


H. PRE-SEDATION EVALUATION

Review of the medical record for Patient #1 did not reveal any documentation of a pre-sedation evaluation performed. There of a pre-procedure medical history and airway assessment on the moderate sedation form. There was no documentation of the ASA physical status classification of the patient. There was no documentation of the NPO (last oral intake) status. There was no documentation that Patient #1 was a candidate for moderate sedation.

The procedure had to be stopped and an alternate procedure performed due to the patient's intolerance of pain during the procedure. Moderate sedation medications were not sufficient to control Patient #1's pain during the procedure. Patient #1 was teary, and the procedure had to be stopped.


An interview with Staff #6 on 10-3-2019 after 11:00 a.m. revealed the following:

Staff #6 was asked if a pre-sedation evaluation was done on Patient #1 prior to the administration of the sedation medications. Staff #6 stated, "I am not aware of any specific form that has to be completed but I did see the patient the day of the procedure and confirm he was NPO."


Review of the nurse's documentation for Patient #1 during the procedure revealed the following:

An untimed entry in the note revealed "several attempts have been made, patient tearful during procedure (see conscious sedation note at 3:08 p.m.

3:17 p.m. radiologist refuses to give additional meds - procedures stopped."


A review of the facility postoperative progress note revealed the following:

"9-12-2019 3:30 p.m., Staff #8 documented, "failure RLQ abscess drain due to patient pain ...."

Staff #2 confirmed the findings on the Pre-Sedation form.


Review of the facility policy titled, "Administration of Moderate Sedation by Non-Anesthesia Personnel" with a revision date of 1/2017 revealed the following:

" ...PHYSICIAN PRE-PROCEDURE ASSESSMENT:

1. The NAPP must document a pre-procedure medical history and airway assessment on the moderate sedation form. History must include review of systems to include cardiopulmonary disease, drug allergies, prior history of adverse reactions to sedation or anesthesia.

2. An ASA physical status classification designation is made and documented.

3. The patient airway is assessed.

4. The NAPP must document the NPO status."