HospitalInspections.org

Based on record review and staff interview it has been determined that the hospital failed to properly execute informed consent forms for procedures and treatments specified by the medical staff for 7 of 7 relevant sample patients (ID #'s 1, 8,9,10,11,12, and 13) related to the time the informed consent was signed.

Findings are as follows:

CMS (Center for Medicare and Medicaid Services) Interpretative Guidelines state that "A properly executed informed consent contains the following minimum elements: .......date and time the informed consent form is signed by the patient or the patient's legal representative."

A review of informed consents for 7 surgical records (ID #'s 1, 8, 9, 10, 11, 12, 13) revealed that the informed consent lacked a time the consent was signed by the patient or the patient's legal representative.

When interviewed on 8/30/12 at approximately 11:00 AM, the Director of Perioperative Services was unable to produce evidence that the informed consents had been signed.

Based on record review, staff interview, and review of hospital policies it was determined that the hospital failed to ensure compliance with policies entitled " Universal Protocol Policy " and "Universal Protocol Policy for the Dental Clinic" for 1 of 4 relevant sample patients (ID #1).

Findings are as follows:

A review of the hospital policy entitled "Universal Protocol Policy" under "Introduction" states:

"The Universal Protocol Policy will encompass all areas of the institution where an invasive procedure occurs ... ...Dental Clinic ... "

Under "Marking the Operative Site", it states:

"For teeth, the operative tooth name(s) and number are indicated on documentation or the operative tooth (teeth) is marked on the dental radiographs or dental diagram. For documentation, images and or/diagrams are available in the procedure room before the start of the procedure".

Under the "Time Out Process", it states:

"An incision will not be made until the circulating nurse/procedure assistant and physician/dentist together along with the SRNA/CRNA/Anesthesiologist (if appropriate) actively verifies the surgical information. The physician will initiate the "time out" for the verification process. All staff involved in the procedure (physician, anesthesia, circulating nurse, scrub tech) will pause, take a time out and verify:

The correct patient
The correct procedure
Correct site/side (confirmed with consent by RN/licensed provider)
Physician's initials on procedure site/side visible after prepping and draping
Can we all see the mark"

In addition, it states: "Patients who have procedures performed at the bedside or outpatient clinic do not have their site marked as long as all the above identification is performed and the physician remains in constant attendance at the bedside. A time out must be performed."

A review of the hospital policy entitled " Universal Protocol Policy for the Dental Clinic" states under "Introduction" :

"The Dental Clinic follows the Universal Protocol Policy of St Joseph Health Services of Rhode Island".

A review of the clinical record for Patient ID #1 revealed a 16 year old who presented to the Dental Clinic on 8/22/12 for planned removal of wisdom teeth (upper and lower 3rd molars #16 and #17 on the left side). However it was determined that through error, tooth #18 (the lower second molar) was removed.

Interview on 8/28/12 at 8:25 AM with a first year post graduate resident who began the procedure, indicated that the area of the gum was anesthetized and the attending dentist then "came in and took a look". The X-rays were reviewed, confirming that tooth #16 and #17 were to be extracted. The attending dentist then looked into the patient's mouth and instructed the resident to "take it out". The resident proceeded to remove the tooth using forceps, but was unable to grab the tooth. The resident indicated that at this point the attending dentist came into the room and asked if the tooth was out, and the resident indicated that it was not. The attending dentist then attempted removal of the tooth using an elevator. He sectioned the tooth, and took the tooth out "piece by piece." The resident indicated "it was challenging." Upon further interview the resident reported that they did not stop and confirm that they were taking out #16 and #17, and that the "Time Out" had not been done. The resident indicated that the tooth that should have been removed was deeper in the tissue and he couldn't see it.

Interview on 8/28/12 at 9:23 AM with the attending dentist indicated that the resident anesthetized the patient and began the surgical procedure. He further indicated that this resident "was good and did not need to wait for him to begin the procedure." He indicated that an X-ray was taken after removal of the tooth, which revealed that the wrong tooth had been removed. The attending dentist indicated the resident did do a "Time Out" before he arrived in the room.

Interview on 8/28/12 at 9:45 AM with the Dental Assistant revealed that the patient had already been anesthetized, and the resident had started the procedure before she arrived in the room. The Dental Assistant further indicated that the resident will usually do the "Time Out" with the attending dentist, and if he is not available, the resident will do the "Time Out" with the Dental Assistant or another resident.

Based on the interview with the post graduate resident who began the procedure, it was determined that a "Time Out" had not been done according to hospital policy.