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RHODE ISLAND HOSPITAL 593 EDDY STREET PROVIDENCE, RI 02903 May 7, 2021
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on record review and staff interview, it has been determined that the hospital failed to provide care in a safe setting for 1 of 1 sample patient, Patient ID #1.

Findings are as follows:

Patient ID #1 presented to the hospital in 4/2021 for a surgical repair of a pseudoarthrosis (unsuccessful spinal fusion) which resulted in hardware loosening and instability with flexing and extending of the spine.

During the procedure, the orthopedic surgeon advanced a surgical instrument under fluoroscopy (using X-rays to obtain real-time images of inside the body) and inadvertently and unknowingly injured the patient's kidney; "significant bleeding was encountered." The Operative Note indicates that the bleeding subsided after approximately 15 minutes, general surgery was consulted, and the orthopedic surgeon continued the procedure.

During the continuation, the Operative Note indicates that "there was significant intraoperative bleeding welling up into the wound" and further states that that the surgeon "felt that the abdomen was significantly distended. Thus the decision was made at this time to abort the procedure for [an] exploratory laparotomy [operation where the abdomen is opened, and the abdominal organs are examined for injury] to detect the source of bleeding" to be performed by general surgery.

General Surgery noted "a large amount of bleeding, hematuria [blood in the urine] and vasopressor [a medication to increase blood pressure] requirement." Upon further examination, the general surgeon identified the blood as coming from the right kidney which resulted in it being removed.

Patient ID #1 received a total of 16 units of packed red blood cells, 3 units of fresh frozen plasma [component of the blood that helps with clotting] and 3 units of platelets [component of blood that helps with clotting] while in the Operating Room.

Patient ID #1 was subsequently transferred to the Trauma Intensive Care Unit (TICU) postoperatively with his/her abdomen left open for further examination.

Review of the Surgical Pathology Report revealed the right kidney had "two torn defects measuring 1.6centimeters (cm) and 4.3 cm."

During surveyor interview with the hospital's Chief of Orthopedics on 4/5/2021 at 9:00 AM, he revealed that the orthopedic surgeon that performed the surgery incorrectly interpreted the fluoroscopy machine which resulted in the kidney being lacerated by the surgical instrument. He further stated that the surgeon "should not have been near the kidney for this procedure."
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on record review and review of hospital policies, it has been determined that the hospital failed to meet the Condition of Participation of Patient's Rights relative to care in a safe setting for 6 of 6 sample patients (Patient ID #'s 1, 3, 4, 5, 6 and 7).

Findings are as follows:

1. The hospital failed to adhere to the policy entitled "Patient Restraint and Seclusion" for 5 of 5 patients relative to nursing assessment and the continued need for a restraint (Patient ID #'s 3, 4,5, 6 and 7). (refer to A-167)

2. The hospital failed to provide care in a safe setting for 1 of 1 patients (Patient ID #1) relative to an Operating Room procedure resulting in an unanticipated removal of a kidney. (refer to A-144)
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
Based on record review, staff interview and review of hospital policy, it has been determined that the hospital failed to adhere to their own policy entitled "Patient Restraint and Seclusion" for 5 of 5 patients relative to nursing assessment (Patient ID #'s 3, 4, 5, 6 and 7).

Findings are as follows:

The hospitals " Patient Restraint and Seclusion " policy, last revised in 2/2020, states in part, that the Registered Nurse (RN) is to assess the patient at the initiation of restraint, and no less than every 2 hours thereafter. The policy further states that the RN is responsible for ensuring that the assessment of the patients' need for continued restraint, physical and psychological status, comfort, response to restraint, skin integrity, circulation, sensation, movement of restrained extremities, range of motion, level of consciousness, nutrition and hydration and hygiene and elimination are assessed and documented every 2 hours.

1. Review of the medical record for Patient ID #3 revealed s/he was hospitalized in 2/2021 for neurological care and treatment after undergoing a thoracic laminectomy (a surgical operation to remove one or more vertebrae, usually performed to relieve pressure on nerves), thoracic area fusion (permanently connects two or more vertebrae) and the evacuation of a hematoma (a collection of blood).

The patient was placed in non-violent restraints (right and left side soft wrist restraints) from 2/16/2021-2/19/2021. Nursing documentation revealed greater than 2 hours without evidence of restraint monitoring for Patient ID #3 on 2/18/2021 from 4:00 PM to 8:00 PM.

Additionally, the nursing documentation lacked evidence of the RN assessing the need for continued restraint on 2/16/2021 at 10:00 AM, 12:00 PM, 2:00 PM, 4:00 PM, 6:00 PM and 10:00 PM, on 2/17/2021 at 12:00 AM, 2:00 AM, 4:00 AM, 6:00 AM, and 10:00 PM, on 2/18/2021 at 12:00 AM, 2:00 AM, 4:00 AM, 8:00 AM, 4:00 PM, 6:00 PM, 8:00 PM and 10:00 PM, and on 2/19/2021 at 2:00 AM

2. Review of the medical record for Patient ID # 4 revealed s/he was hospitalized in 5/2021 for weakness and altered mental status. Patient ID # 4 was placed in non-violent restraints (right and left side soft wrist restraints) from 5/3/2021-5/5/2021. Nursing documentation lacked evidence of the RN assessing the need for continued restraint on 5/4/2021 at 12:00 AM, 2:00 AM, 4:00 AM, 6:00 AM, 6:00 PM and 8:00 PM, and on 5/5/2021 at 12:00 AM and 2:00 AM.

3. Review of the medical record for Patient ID #5 revealed s/he was hospitalized in 4/2021 for treatment of a knee infection. Postoperatively, Patient ID #5 was placed in non-violent restraints (right and left side soft wrist restraints) from 4/30/2021-5/5/2021. Nursing documentation reveals greater than 2 hours without evidence of restraint monitoring for Patient ID #5 on 5/2/2021 from 4:00 PM to 8:00 PM and on 5/4/2021 from 8:00 PM- 12:00 AM.

Additionally, nursing documentation lacked evidence of the RN assessing the need for continued restraint on 4/30/2021 at 6:00 PM, 8:00 PM, and 10:00 PM, on 5/1/2021 at 12:00 PM, 4:00 PM, 6:00 PM, and 8:00 PM, on 5/2/2021 at 8:00 AM, 10:00 AM, 12:00 PM, 4:00 PM, 6:00 PM, 8:00 PM and 10:00 PM, on 5/4/2021 at 4:00 AM, 6:00 AM, 8:00 AM, 10:00 AM, 2:00 PM and on 5/5/2021 at 4:00 AM, 6:00 AM and 9:54 AM

4. Review of the medical record for Patient ID #6 revealed s/he was hospitalized in 2/2021 for treatment of respiratory failure. Patient ID #6 was placed in non-violent restraints (right and left side soft wrist restraints) from 2/28/2021-3/1/2021. Nursing documentation reveals greater than 2 hours without evidence of restraint monitoring for Patient ID #6 on 2/28/2021 from 4:00 PM-8:00 PM.

Additionally, nursing documentation lacked evidence of the RN assessing the need for continued restraint on 2/28/2021 at 10:00 PM and on 3/1/2021 at 12:00 AM and 2:00 AM.

5. Review of the medical record for Patient ID #7 revealed s/he was hospitalized in 4/2021 after being found unresponsive and covered in vomit. While inpatient, Patient ID #7 was placed in non-violent restraints (right and left side soft wrist restraints) from 4/29/2021-5/5/2021. Nursing documentation revealed greater than 2 hours without evidence of restraint monitoring for Patient ID #6 on 4/29/2021 from 3:03 AM- 6:00 AM, on 4/29/2021 from 4:00 AM-7:00 AM, and on 5/4/2021 from 11:35 AM- 2:00 PM.

Additionally, the nursing documentation lacked evidence of the RN assessing the need for continued restraint on 4/29/2021 at 6:00 AM, 10:00 AM and 12:00 PM, on 4/30/2021 at 7:00 PM and on 5/4/2021 at 8:00 PM.

During an interview with hospital Risk Manager and the Clinical Informatics Analyst on 5/7/2021 at approximately 2:45 PM, they were unable to provide evidence that the hospital policy had been followed relative to nursing restraint monitoring and documentation for the above patients.
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on record review and staff interview it has been determined that the hospital failed to ensure that there was a complete history and physical examination (H&P) in the medical record prior to surgery for 2 of 7 patients, Patient ID's #1 and 2.

Findings are as follows:

"The Rules and Regulations of the [Hospital's] Medical Staff," last revised in January 2020, state, in part:

" ...V. Medical Records ...
2. History and Physical (H&P) ...The history and physical should include the chief complaint ...present illness, including, allergies and medications ..."

1. Review of the medical record for Patient ID #1 revealed the patient presented for surgery in April 2021. Further review of the medical record revealed the H&P lacked, at a minimum, evidence of the patient's current medications.

2. Review of the medical record for Patient ID #2 revealed the patient presented for surgery in March 2021. Further review of the medical record revealed that the H&P lacked, at a minimum, evidence of the patient's current medications.

During surveyor interview with the Chief Medical Officer (CMO) on 5/5/2021, he acknowledged that the H&P's for Patient ID #'s 1 and 2 failed to identify or refer to a list for identification of the patients current medications as per the hospital medical staff Rules and Regulations.