The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RHODE ISLAND HOSPITAL 593 EDDY STREET PROVIDENCE, RI 02903 March 29, 2018
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on record review and staff interviews it has been determined that the facility has failed to meet the Condition of Participation relative to Patient's Rights. The facility failed to meet the standards of practice related to A 131 for 3 residents reviewed Patient ID # 1, Patient ID # 2 and Patient ID # 8, for failing to afford patients the right to make informed decisions regarding his or her care. (Refer to A 131.)

In addition, the facility failed to meet the standards of practice related to A 144 for failing to protect patient safety as evidenced by failing to verify patient identification prior to performing radiological procedures for 3 patients, Patient ID # 1, Patient ID # 2 and Patient ID # 8. (Refer to 144.)
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**






Based on clinical record review and staff interview, it has been determined that the hospital failed to afford patients the right to make informed decisions regarding his or her care for 3 residents reviewed Patient ID # 1, Patient ID # 2 and Patient ID # 8.

Findings are as follows:


1. Clinical record review for Patient ID #1 revealed a significant event note written on 02/26/2018 at 1:14 PM by the physician. This note stated, "At approximately 1 AM on 2/26 ...We took ... (ID#1) to the angiography suite for possible thrombectomy (removal of blood clots)...Immediately after this angiogram, it was discovered that the patient had been mis-identified ..."

A hospital self-report indicated "The patient underwent an uncomplicated angiogram intended for another patient." (This test involves insertion of a long catheter into an artery, injection of a contrast agent, and fluoroscopic x-rays of the affected area.)

An interview was conducted on 03/08/2018 at approximately 1:00 PM with the physician who performed the angiogram. He stated his team was notified, in advance, of a patient arriving to the hospital from another hospital for an emergent angiogram for a diagnosed large vessel occlusion/stroke. He went on to state, he and a nurse practitioner (NP) were waiting in the ambulance bay of the emergency department for the arrival of the patient. While they were waiting , ID # 1 arrived from the community, accompanied by EMS. The physician stated that based on clinical presentation, ID # 1 was mis-identified as the patient being transferred from another hospital. The physician went on to state the angiogram is performed emergently and therefore does not require informed consent.

An interview was conducted on 03/09/2018 at 8:45 AM with the NP who was involved in the case. He stated, he and the physician were in the ambulance bay of the emergency department awaiting the arrival of a patient from another hospital who was on route for an emergent angiogram possible thrombectomy. It was revealed that he did not verify the patient's identity of Patient ID # 1 prior to performing the angiogram.

The hospital could not provide evidence that the patient was given the opportunity to refuse this treatment.

2. Clinical record review for patient ID # 2 revealed, the patient was admitted on [DATE] at 4:19 PM with headache, nausea and dizziness.

A self-report by the hospital revealed " ...Provider ordered a Computed Tomography Angiography (CTA) brain and neck with/without intravenous (IV) contrast which was intended to be ordered for a different patient ..."

Medical record review revealed a physician's order was placed on 02/21/2018 at 4:53 PM for a Computed Tomography (CT) scan Brain without IV contrast. Review of the Radiology report revealed this CT was completed with normal results. Further review revealed an order placed on 02/21/2018 at 6:35 PM for a CTA Brain and Neck, WWO (with and without) IV contrast. Review of the radiology report revealed the CTA was completed with contrast at 6:46 PM, with normal results.

An interview was conducted on 03/08/2018 at 10:05 AM with the ordering physician assistant (PA) and the medical director of the emergency department. The PA stated that when the CTA was completed, the Radiologist called her and asked why she had ordered the CTA. At that point, she realized she had ordered the CTA for the wrong patient.

When questioned regarding consent for this procedure, the PA stated diagnostic testing is covered in the general consent when patients arrive in the emergency room . She stated she informed the patient about the intended test, but the patient was not informed prior to receiving the unintended CTA and therefore was not afforded the right to refuse this treatment.

3. Clinical record review revealed Patient ID # 8 had an abnormal right breast mammogram on 02/15/2018. The impression stated "need additional imaging...an ultrasound is recommended...will contact the patient and schedule."

Further record review of the order control sheet revealed Patient ID # 8 had a scheduled appointment for an ultrasound of the right breast on 03/16/2018 at 1:30 PM.

Clinical record review for Patient ID # 7 revealed the patient had a mammogram on 02/27/2018. The impression stated "need additional imaging...additional views with possible ultrasound are recommended."

Further record review of the order control sheet revealed Patient ID # 7 had a scheduled appointment for an ultrasound of the right breast on 03/19/2018 at 3:30 PM.

A self report by the hospital revealed a right breast mammogram was performed on Patient ID # 8 (on 3/16/2018) when a right breast ultrasound was ordered. There was no evidence of a consent for the mammogram.

An interview was conducted on 03/27/2018 at approximately 2:00 PM with the technologist who performed the mammogram. She stated she identified the patient by the name on the jacket, which was Patient ID # 8's name and the Patient's identification band. She failed to review the documents, containing the written recommendations which had Patient ID # 7's name on them, prior to performing the procedure. The patient was not informed prior to receiving the unintended mammogram and therefore was not afforded the right to refuse this treatment. Additionally Patient ID # 8 received a mammogram which was intended for Patient ID # 7.

An interview was conducted on 03/29/2018 at 10:20 AM with the diagnostic imaging patient processor in the breast imaging center . She explained the procedure for patients who are called back for further imaging. She stated the order control sheet along with the radiology report, which states the testing which is to be performed, is placed in the patient jacket which has the patient's name on the outside of the jacket. She stated the order control sheet and radiology report for Patient ID # 7 was placed in the jacket with Patient ID # 8's name on it. Furthermore she could not explain how the documents for Patient ID # 7 were placed in the jacket with Patient ID # 8's name on the outside.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**







Based on record review and staff interview it has been determined that the hospital failed to protect patient safety as evidenced by failing to verify patient identification prior to performing radiological procedures for 3 patients, Patient ID # 1, Patient ID # 2 and Patient ID # 8.

Findings are as follows:

Review of the Hospital Policy titled "Patient Identification and Verification" states in part:

"II. Policy
All patients must be properly identified prior to any care, treatment or services being provided ...

III. Definitions
Identification - the act of finding out and ensuring who the patient is
Verification - the process to ascertain and prove a patient's identity.

IV. Procedure
Patient Identification

Prior to any care, treatment or services provided, the caregiver will identify/verify with the patient, the patients name and date-of-birth. Admitting and patient registration are responsible for reviewing all available documentation needed to establish patient identity."

1. Review of the Rhode Island Emergency Medical Service (EMS) Patient Care Report provided to the surveyor by the Fire Department revealed patient ID # 1 arrived at the hospital at 11:26 PM on 02/25/2018 with difficulty speaking, left arm numbness and right eye blur.

A hospital self-report indicated "The patient underwent an uncomplicated angiogram intended for another patient."

Review of a significant event note written on 02/26/2018 at 1:14 PM by the physician who performed the angiogram revealed that "At approximately 1 AM on 2/26 ...We took ... (ID#1) to the angiography suite for possible thrombectomy ...Immediately after this angiogram, it was discovered that the patient had been mis-identified.

An interview was conducted with the doctor who performed the angiogram on 03/08/2018 at 1:00 PM. He stated his team was notified in advance of a patient arriving to the hospital from another hospital for an emergent angiogram for a diagnosed large vessel occlusion/stroke. He went on to state that he and his nurse practitioner (NP) were in the ambulance bay of the emergency department awaiting the arrival of the patient being transferred. When ID # 1 arrived accompanied by the EMS, ID # 1 was mis-identified as the patient being transferred from another hospital based solely on clinical presentation.

An interview was conducted on 03/09/2018 at 8:45 AM with the NP. He stated that he and the doctor were in the ambulance bay of the emergency department awaiting the arrival of a patient from another hospital. They had been informed the patient was on route for an emergent angiogram and possible thrombectomy. When ID # 1 arrived, he asked the patient for his/her name and date of birth. He went on to state that because of difficulty speaking, the patient could not provide this information. When asked, how he identified the patient, he stated, he asked the EMS "is this the stroke from ... (other hospital)." The NP stated he did not get a clear answer from the EMS. The NP then stated he placed the identification bracelet he had printed for the patient they were expecting and placed it on ID # 1, without verifying the patients name and date of birth. They then proceeded to interventional radiology for the angiogram. He could not provide evidence that he verified the patient's identification prior to the angiogram.

2. Record review for ID # 2 revealed, the patient was admitted on [DATE] at 4:19 PM with headache, nausea and dizziness.

A self-report by the hospital revealed " ...Provider ordered a Computed Tomography Angiography (CTA) brain and neck with/without intravenous (IV) contrast which was intended to be ordered for a different patient ..."

Medical record review revealed a physician's order was placed on 02/21/2018 at 4:53 PM for a Computed Tomography (CT) scan Brain without IV contrast. Review of the Radiology report revealed this CT was completed with normal results. Further review revealed an order placed on 02/21/2018 at 6:35 PM for a CTA Brain and Neck, WWO (with and without) IV contrast. Review of the radiology report revealed the CTA was completed with contrast at 6:46 PM, with normal results.

An interview was conducted on 03/08/2018 at 10:05 AM with the ordering physician assistant (PA) and the medical director of the emergency department. The PA stated that when the CTA was completed, the Radiologist called her and asked why she had ordered the CTA. At that point, she realized she had ordered the CTA for the wrong patient. She could not provide evidence that she verified the patient's identity, prior to ordering the CTA.


3. Clinical record review revealed Patient ID # 8 had an abnormal right breast mammogram on 02/15/2018. The impression stated "need additional imaging...an ultrasound is recommended...will contact the patient and schedule."

Further record review of the order control sheet revealed Patient ID # 8 had a scheduled appointment for an ultrasound of the right breast on 03/16/2018 at 1:30 PM.

Clinical record review for Patient ID # 7 revealed the patient had a mammogram on 02/27/2018. The impression stated "need additional imaging...additional views with possible ultrasound are recommended."

Further record review of the order control sheet revealed Patient ID # 7 had a scheduled appointment for an ultrasound of the right breast on 03/19/2018 at 3:30 PM.

A self report by the hospital revealed a right breast mammogram was performed on Patient ID # 8 (on 3/16/2018) when a right breast ultrasound was ordered.

An interview was conducted on 03/27/2018 at approximately 2:00 PM with the technologist who performed the mammogram. She stated she identified the patient by the name on the jacket, which was Patient ID # 8's name and the Patient's identification band. She failed to review the documents, containing the written recommendations which had Patient ID # 7's name on them, prior to performing the procedure. The Patient ID # 8 received a mammogram which was intended for Patient ID # 7.

An interview was conducted on 03/29/2018 at 10:20 AM with the diagnostic imaging patient processor in the breast imaging center . She explained the procedure for patients who are called back for further imaging. She stated the order control sheet along with the radiology report, which states what test is to be performed, is placed in the patient jacket, which has the patient's name on the outside of the jacket. She could not explain how the order control sheet and radiology report for Patient ID # 7 was placed in the wrong jacket with the name of Patient ID # 8 on the outside.
VIOLATION: RADIOLOGIC SERVICES Tag No: A0528
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**







Based on record review, surveyor observations, and interview with staff, it is determined the hospital failed to provide radiological services that meet professionally approved standards for safety for 3 of 8 relevant sample records reviewed. This is related to the occurrence of a misidentification of a patient who underwent a diagnostic angiogram (ID #1), a patient who received an unintended CTA (ID # 2) and a patient who underwent an unintended mammogram (ID #8) in accordance with policy and procedures in the Interventional and Diagnostic Radiology areas. Refer 539. In addition the hospital failed to meet the standards for personnel qualifications (Refer to 547), periodic equipment maintance and testing (Refer to 537), and monitoring personnel radiation exposure (Refer to 538).

Findings are as follows:

A) Hospital Policy Administration 18, Titled "Identifying Patients for Diagnostic Imaging Exams or Procedures" states in part:
Under "III Policy:
-Two forms of patient identification (ID) are required before an imaging exam can be performed
-Patient identity and their exam orders will be verified using the TPESR + process before the exam is performed.
V. Procedure:
6. The technologist performing the imaging exam will then...verify the patients identity and the exam using the TPESR+ process... 1. (T)-Time and date of the order 2. (P)-Patient ID 3. (E)-Exam ordered 4. (S)-Side and labeling 5. (R)- Reason for exam."

B) Hospital Policy: Administration 108, Titled "Universal Protocol: for Procedures Performed Outside of the Operating Room (OR): Verification of Patient Identity Procedure and Site/Side" states in part:
Under "I. Purpose:
-To establish a safe, accurate and consistent identification process for verification and documentation of the patient's identity and the intended invasive procedure of more than minimal risk, including procedure site and when applicable, side."

C) Hospital Diagnostic Imaging Policy, Administration 63, Titled "Scope of Services" states in part:
Under "Orders:
-All (Diagnostic Imaging) DI exams require a written or electronic order prior to performing the exam
Under "Radiation Safety:
-Successful completion of a radiation safety online course is required for all medical staff members using fluoroscopy."



1. Clinical Record review revealed Patient ID # 1 arrived at the hospital at 11:30 PM and was taken directly to the Interventional Radiology Suite. The patient received a diagnostic angiogram without a practitioner order.

Further record review of a significant event note written on 02/26/2018 at 1:14 PM by the physician who performed the angiogram revealed that, "At approximately 1 AM on 2/26 ...We took ... (ID#1) to the angiography suite for possible thrombectomy (removal of blood clots)...Immediately after this angiogram, it was discovered that the patient had been misidentified ..."

An interview was conducted on 03/08/2018 at 1:00 PM with the physician who performed the angiogram. He stated his team was notified, in advance, of a patient arriving to the hospital from another hospital for an emergent angiogram for a diagnosed large vessel occlusion/stroke. He went on to state, he and a nurse practitioner (NP) were waiting in the ambulance bay of the emergency department for the arrival of the patient. While they were waiting , Patient ID # 1 arrived from the community, accompanied by the EMS. The physician stated that based on clinical presentation, Patient ID # 1 was mis-identified as the patient being transferred from another hospital. He was unable to provide evidence of a practitioners order for the diagnostic angiogram for this patient ID # 1..

2. Clinical record review for patient ID # 2 revealed, the patient was admitted on [DATE] at 4:19 PM with headache, nausea and dizziness.

A self-report by the hospital revealed " ...Provider ordered a Computed Tomography Angiography (CTA) brain and neck with/without intravenous (IV) contrast which was intended to be ordered for a different patient ..."

Medical record review revealed a physician's order was placed on 02/21/2018 at 4:53 PM for a Computed Tomography (CT) scan Brain without IV contrast. Review of the Radiology report revealed this CT was completed with normal results. Further review revealed an order placed on 02/21/2018 at 6:35 PM for a CTA Brain and Neck, WWO (with and without) IV contrast. Review of the radiology report revealed the CTA was completed with contrast at 6:46 PM, with normal results.

An interview was conducted on 03/08/2018 at 10:05 AM with the ordering physician assistant (PA) and the medical director of the emergency department. The PA stated that when the CTA was completed, the Radiologist called her and asked why she had ordered the CTA. At that point, she realized she had ordered the CTA for the wrong patient.


3. Clinical record review revealed Patient ID # 8 had an abnormal right breast mammogram on 02/15/2018. The impression stated "need additional imaging...an ultrasound is recommended...will contact the patient and schedule." Patient ID # 8 arrived for the follow up and underwent a right breast mammogram on 3/16/2018. Record review failed to reveal a practitioners order for the mammogram, for this patient ID # 8.

An interview was conducted on 03/27/2018 at approximately 9:00 AM with the Radiological Technologist. She acknowledged that she performed the mammogram without a practitioner's order for this patient ID # 8.
VIOLATION: PERIODIC EQUIPMENT MAINTENANCE Tag No: A0537
Based on a review of medical physics reports and staff interview it was determined the hospital failed to determine that any problems identified through the testing and maintenance program were properly corrected in a timely manner for 1 of 1 C-Arm fluoroscopy unit that failed a portion of the annual survey, Interventional Radiology (IR) suite #1. This unit was utilized for interventional procedures through 03/28/2018 at which time it was brought to the attention of the Radiation Safety Officer and re-surveyed for conformance with Health and Human Services (HHS) standards.

Findings are as follows:

Review of state RULES AND REGULATIONS FOR THE CONTROL OF RADIATION states in part:

F.3 GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC X-RAY SYSTEMS
F.3.1 In addition to other requirement of Part F, all diagnostic X-ray systems shall meet the requirements of
Subpart F.3.
F.3.2 Maintaining Compliance. Diagnostic X-ray systems and their associated components used on humans and certified pursuant to the Federal X-ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

F.4.18 Displays of Values of Air Kerma (Exposure) Rate and Cumulative Air Kerma. Fluoroscopic equipment manufactured on or after 10 June 2006, shall display at the operator ' s working position the air kerma (exposure) rate and cumulative air kerma. The following requirements apply for each X-ray tube used during an examination or procedure:
(f) The displayed air kerma (exposure) rate and cumulative air kerma shall not deviate from the actual values by more than thirty-five percent ( 35%) over the range of 6 mGy/min and 100 mGy to the maximum indication of air kerma (exposure) rate and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three (3) seconds.

In addition, review of the hospital's policy C) Hospital Diagnostic Imaging Policy, Administration 63, Titled "Scope of Services" states in part:
Under "Equipment:
-The Medical Physicist check ionizing radiation equipment...once a year and validate the machines are working within prescribed ranges."

Review of the annual medical physics survey report dated 04/03/2017 for the C- Arm unit in IR suite #1, that continued to remain in use, showed the Dose Area Product/Air Kerma Verification failed.

Review of Toshiba biomedical engineering field service report dated 04/04/2017 revealed the Toshiba method of measurement was utilized to determine compliance as opposed to state and federal (HHS) method as outlined in the federal regulations.

An interview was conducted on 03/28/2018 at approximately 3:00 PM with the Radiation Safety Officer. He stated a follow up survey should have been conducted on the unit to demonstrate the Dose Area Product/Air Kerma Verification was in compliance with the state and federal (HHS) standards.
VIOLATION: MONITORING RADIATION EXPOSURE Tag No: A0538
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on record review, surveyor observation and staff interview it was determined the facility failed to provide a radiation dosimeter badges for radiation exposure for 1 of 1 practitioner (Staff A) who was observed in the Operating Room (OR) in close proximity to the fluoroscopy unit. Also the hospital failed to ensure a radiation dosimeter badge was appropriately worn by 1 of 1 physician (Staff B) observed in the OR that utilizing a fluoroscopy unit.

D) Review of state RULES AND REGULATIONS FOR THE CONTROL OF RADIATION states in part:

A.3.3 Conditions Requiring Individual Monitoring of External and Internal Occupational Dose. Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this Part. As a minimum:
(a) Each licensee or registrant shall monitor occupational exposure to radiation from licensed, registered, unlicensed and unregistered radiation sources under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:
(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10
percent of the limits in A.2.3(a);

In addition, review of the facilities policy for C) Hospital Diagnostic Imaging Policy, Administration 63, Titled "Scope of Services" states in part:
-Radiation workers wear radiation badges to monitor exposure

Surveyor observation in the OR on 03/27/2018 at approximately 11:15 AM, revealed Staff A in close proximity to the C-Arm Fluoroscopy unit. He was observed without a dosimeter badge. Staff B was also observed utilizing the C-Arm unit. He was observed not wearing a dosimeter badge.

Review of the credentialing file for Staff A revealed he was approved by the board to practice neurosurgery at the hospital on [DATE]. Review of radiation dosimeter reports revealed no evidence that Staff A was issued a dosimeter badge.

An interview was conducted on 03/28/2018 at approximately 10:30 AM with the Director of Regulatory Readiness she revealed that Staff A was never issued a radiation dosimeter badge. She confirmed that Staff B was not wearing his badge during the procedure.

The hospital was unable to provide evidence as to why staff A, who was in training to utilize radiological equipment, had not been issued a dosimeter badge.
VIOLATION: MEDICAL ORDERS FOR RADIOLOGY SERVICES Tag No: A0539
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and staff interview it was determined that the facility failed to provide radiological services on the order of the practitioner for 3 records reviewed with radiological orders. Patient ID #1, #2 and Patient ID # 8.

1. Clinical record review for Patient ID # 1 revealed a significant event note written on 02/26/2018 at 1:14 PM by the physician revealed that, "At approximately 1 AM on 2/26 ...We took ... (ID#1) to the angiography suite for possible thrombectomy (removal of blood clots)...Immediately after this angiogram, it was discovered that the patient had been mis-identified ..."

Further record review revealed Patient ID # 1 arrived at the hospital at 11:30 PM and was taken directly to the Interventional Radiology Suite. Patient received a diagnostic angiogram without a practioners order.

An interview was conducted on 03/08/2018 at 1:00 PM with the physician who performed the angiogram. He stated his team was notified, in advance, of a patient arriving to the hospital from another hospital for an emergent angiogram for a diagnosed large vessel occlusion/stroke. He went on to state, he and a nurse practitioner (NP) were waiting in the ambulance bay of the emergency department for the arrival of the patient. While they were waiting , ID # 1 arrived from the community, accompanied by the EMS. The physician stated that based on clinical presentation, ID # 1 was mis-identified as the patient being transferred from another hospital. He was unable to provide evidence of a practioners order for the diagnostic angiogram for Patient ID # 1.

2. Clinical record review for patient ID # 2 revealed, the patient was admitted on [DATE] at 4:19 PM with headache, nausea and dizziness.

A self-report by the hospital revealed " ...Provider ordered a Computed Tomography Angiography (CTA) brain and neck with/without intravenous (IV) contrast which was intended to be ordered for a different patient ..."

Medical record review revealed a physician's order was placed on 02/21/2018 at 4:53 PM for a Computed Tomography (CT) scan Brain without IV contrast. Review of the Radiology report revealed this CT was completed with normal results. Further review revealed an order placed on 02/21/2018 at 6:35 PM for a CTA Brain and Neck, WWO (with and without) IV contrast. Review of the radiology report revealed the CTA was completed with contrast at 6:46 PM, with normal results.

An interview was conducted on 03/08/2018 at 10:05 AM with the ordering physician assistant (PA) and the medical director of the emergency department. The PA stated that when the CTA was completed, the Radiologist called her and asked why she had ordered the CTA. At that point, she realized she had ordered the CTA for the wrong patient.


4. Clinical record review revealed Patient ID # 8 revealed the Patient had an abnormal right breast mammogram on 02/15/2018. The impression stated "need additional imaging...an ultrasound is recommended...will contact the patient and schedule."

Patient ID # 8 arrived for the follow up and underwent a right breast mammogram. Record review failed to reveal a practioners order for the mammogram.

An interview was conducted on 03/27/2018 at 2:00 PM with the Radiological Technologist who performed the mammogram. She acknowledged that she performed the mammogram without a practioners order.
VIOLATION: QUALIFIED STAFF Tag No: A0547
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on staff interview and review of credentialing files it has been determined that the hospital failed to ensure that all personel who use the fluoroscopic x-ray equipment for interventional procedures have completed the appropriate training.

Finding are as follows:

Review of state RULES AND REGULATIONS FOR THE CONTROL OF RADIATION states in part:

"F.2.3(c)(7)
(7) Applicable requirements of these Regulations.

(d) Effective 1 July 2014, the registrant shall either provide in-service training for all operators of
fluoroscopic x-ray systems used for high dose, high risk procedures, as defined in F.4.15 of these Regulations,
at intervals not to exceed twenty-four (24) months or require evidence of continuing medical education, in
fluoroscopic radiation safety and patient dose management at intervals not to exceed twenty-four (24) months."


1. Review of the credentialing file for Staff A revealed he was approved by the board to practice neurosurgery at the hospital on [DATE]. Further review revealed no evidence that he received the required fluoroscopy training.

2. Review of the credentialing file for Staff D revealed that he is completing a vascular interventional radiology fell owship which commenced 07/2017. Further review revealed no evidence that he received the required fluoroscopy training.

An interview was conducted on 03/23/2018 at approximately 8:20 AM with the Director of Physician Affairs and and the Director of Regulatory Readiness. After review of the credentialing file they were unable to produce evidence that Staff D had received the required training in the last 24 months.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on record review and staff interviews it has been determined that the facility has failed to meet the Conditions of Participation relative to surgical Services, for two patients, ID # 1 relative to misidentification and ID # 3 relative wrong site procedure. The hospital failed to assure the achievement and maintenance of high standards of medical practice and patient care. The hospital failed to implement policies relative to patient care including patient consents, patient identification procedures, safety procedures and event reporting. Refer to 951.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**







Based on record review and staff interview it has been determined that the hospital failed to assure the achievement and maintenance of high standards of medical practice and patient care. The hospital failed to implement policies relative to patient care including patient consents, patient identification procedures, safety procedures and event reporting.

Findings are as follows:

Review of the Hospital Policy titled "Patient Identification and Verification" states in part:

"II. Policy

All patients must be properly identified prior to any care, treatment or services being provided ...

III. Definitions

Identification - the act of finding out and ensuring who the patient is

Verification - the process to ascertain and prove a patient's identity.

IV. Procedure

Patient Identification

Prior to any care, treatment or services provided, the caregiver will identify/verify with the patient, the patients name and date-of-birth. Admitting and patient registration are responsible for reviewing all available documentation needed to establish patient identity."


1. Clinical record review for Patient ID # 1 revealed a significant event note written on 02/26/2018 at 1:14 PM by the physician revealed that, "At approximately 1 AM on 2/26 ...We took ... (ID#1) to the angiography suite for possible thrombectomy (removal of blood clots)...Immediately after this angiogram, it was discovered that the patient had been mis-identified ..."

A hospital self-report indicated "The patient underwent an uncomplicated angiogram intended for another patient." (This test involves insertion of a long catheter into an artery, injection of a contrast agent, and x-rays of the affected area.) The hospital failed to identify and verify patients identity and failed to provide the opportunity for informed consent.

An interview was conducted on 03/08/2018 at 1:00 PM with the physician who performed the angiogram. He stated his team was notified, in advance, of a patient arriving to the hospital from another hospital for an emergent angiogram for a diagnosed large vessel occlusion/stroke. He went on to state, he and a nurse practitioner (NP) were waiting in the ambulance bay of the emergency department for the arrival of the patient. While they were waiting , Patient ID # 1 arrived from the community, accompanied by the EMS. The physician stated that based on clinical presentation, Patient ID # 1 was mis-identified as the patient being transferred from another hospital. The physician went on to state the angiogram is performed emergently and therefore does not require informed consent.

An interview was conducted with the NP who was involved in the case on 03/09/2018 at 8:45 AM. He stated, he and the doctor were in the ambulance bay of the emergency department awaiting the arrival of a patient from another hospital who was on route for an emergent angiogram possible thrombectomy. It was revealed that he did not verify the patient's identity prior to the angiogram being performed, nor did he provide the opportunity for informed consent.

Hospital Policy, Administration 108, entitled "Universal Protocol: for Procedures Performed Outside of the Operating Room (OR): Verification of Patient Identity Procedure and Site/Side" states in part:

Under "I. Purpose

To establish a safe, accurate and consistent identification process for verification and documentation of the patient's identity and the intended invasive procedure of more than minimal risk, including procedure site and when applicable, side."

Hospital policy, Administration 100, entitled "Event Reporting System, Management and Analysis Policy" states in part:

Under " IV Procedure:

A. Reporting patient safety events,

Who reports: Generally, the employee or staff member who is involved, observes, or first becomes aware of a patient safety event, should enter an event report..."

When to report: All reports should be completed at the time of detection of the event or as soon as possible.

Serious Problems: ...Any unexpected patient safety event that may constitute a serious problem or serious harm to a patient must be reported immediately by phone to Risk Management..."


2. Clinical record review revealed Patient ID # 3 was admitted on [DATE] with a cervical spine fracture at cervical vertebrae number 7 (C-7). Further record review revealed informed consent was obtained by the practitioner and signed by both the patient and the practitioner on 03/12/2018, for C-7 vertebroplasty (injection of cement into the vertebral body) and possible angiogram with embolization. Further review of nurses notes revealed the patient was taken to Interventional Radiology (IR), was positioned on table for the procedure at 5:57 PM. The procedure was completed at 7:45 PM. Post review of imaging, per Staff E revealed "At this time it was recognized {on virtual CT (Computed Tomography)} that the polymer (cement) placement had been in to the body of (cervical vertebrae number 6) C-6."

A hospital self report indicated " The patient was scheduled to have a C-7 vertebroplasty... during the C-7 vertebroplasty...a post procedure virtual CT was performed... and the vertebroplasty was identified to be performed at C-6..."

An interview was conducted on 03/23/2018 at approximately 12:10 PM with Staff E, the practitioner who performed the procedure. He explained the procedure and acknowledged that he performed the vertebroplasty on C-6 as opposed to the intended site C-7.

An interview was conducted on 03/28/2018 at approximately 2:00 PM with Staff F, the nurse who was present during the vertebroplasty. She stated she did not report the occurrence, she felt the practitioner had rectified the situation during the procedure and was unaware this occurrences should have been reported to Risk Management.