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115 LINCOLN STREET

FRAMINGHAM, MA 01701

No Description Available

Tag No.: A0287

Based on interview and documentation review, it was determined the Hospital had not (yet) finished its Investigation related to Patient #1's unexpected surgical outcome.

Findings included:

Documentation indicated Patient #1; a patient who underwent a septoplasty, bilateral turbinectomy, right and left maxillary sinus aurostomy. Documentation also indicated: Patient #1 complained of loss of vision and pain in the right eye immediately following the surgery.

Interview with the Risk/Quality Patient Safety Staff Member #1 and interview with the Attending ENT Surgeon, revealed the Attending ENT Surgeon decided voluntarily not to perform sinus surgery at this Hospital. However, the Hospital had not yet implemented corrective action regarding the review of the unexpected surgical outcome of Patient #1's surgery.

INFORMED CONSENT

Tag No.: A0955

Based on record review and interview, a Hospital Surgeon failed to properly execute informed consent for 1, (Patient #1) of 22 sampled patients.

Findings include:

1. Patient #1's Surgical Consent Form dated, 6/24/11and timed 1:00 PM indicated Patient #1 gave consent for a septoplasty, bilateral turbinectomy, right and left maxillary sinus aurostomy. The Consent Form did not include the major risks of the surgery or the alternatives to the surgery.

Hospital policy for informed consent indicated a physician was required to obtain consent for all therapeutic and diagnostic procedures where disclosure of information would materially assist the patient in making a decision about the procedure. The physician obtaining the consent should include that a discussion took place which include seven elements; one of the seven elements indicated the potential benefits, risk, or side effects related to alternatives, including the possible results of not receiving care, treatment and services be documented. The Hospital policy also identified that the physician who participates in the consent process should also document in the patient's record a summary of the informed consent discussion in the patient's medical record on the Consent Form.

The Attending ENT Surgeon was interviewed in person on 7/13/11 at 11:30 AM. The Attending Surgeon said he explained to Patient #1 that postoperatively she/he could develop bleeding and/or infection. The Attending Surgeon said he did not review the major risks such as problems with the eyes and or the brain.

OPERATIVE REPORT

Tag No.: A0959

Based on record review Attending ENT Surgeon failed to write or dictate an operative report describing techniques, findings and tissues removed or altered for 17 patients in a sample of 22.

Findings include:

Patient #1 underwent a septoplasty, bilateral antrostomy and enlargement of natural osteim on 7/1/11. The Attending ENT Surgeon dictated the detailed Operative Report on 7/15/11.

Patient #2 underwent a septoplasty and turbinectomy on 3/18/11 and the Attending ENT Surgeon dictated the Operative Report 3/25/11.

Patient #3 underwent bilateral ablations of the turbinates on 3/8/11 and the Attending ENT Surgeon dictated the Operative Report on 3/19/11.

Patient #4 underwent bilateral ablations of the turbinates on 3/28/11 and the Attending ENT Surgeon dictated the Operative Report on 4/14/11.

Patient #5 underwent bilateral turbinates oblations and 2 divisions of the left nasal synechia on 5/24/11 and the Attending ENT Surgeon dictated the Operative Report on 6/1/11.

Patient #6 underwent a bilateral ablations turbinates on 12/6/10, a brief op note was present, however the Attending ENT Surgeon did not document an Operative Report.

Patient #7 underwent a septoplasty and partial bilateral turbinectomy on 4/8/11 and the Attending ENT Surgeon dictated the Operative Report on 4/15/11.

Patient #8 underwent a septoplasty, left sided turbinectomy and an excision of a cyst on the patients lower lip on 2/11/11 and the Attending ENT Surgeon dictated the Operative Report on 3/1/11.

Patient #9 underwent a septoplasty and bilateral turbinectomy on 12/20/10 and the Attending ENT Surgeon dictated the Operative Report on 12/29/10.

Patient #10 under went bilateral turbinate ablations and a biopsy of a left ear lesion on 4/25/11 and the Attending ENT Surgeon dictated the Operative Report on 5/4/11.

Patient #11 underwent a septoplasty and bilateral turbinectomy on 3/25/11 and the Attending ENT Surgeon dictated the Operative Report on 3/28/11.

Patient #12 underwent a tonsillectomy with bilateral Caldwell procedure at 2:55 PM and the Attending ENT Surgeon dictated the Operative Report on 3/28/11.

Patient #13 underwent a septoplasty and bilateral turbinectomy on 2/25/11 and the Attending ENT Surgeon dictated the Operative Report on 3/3/11.

Patient #14 underwent a tonsillectomy with bilateral turbinectomy on 1/5/11 and the Attending ENT Surgeon dictated the Operative Report on 1/18/11.

Patient #15 underwent a septoplasty and bilateral turbinectomy on 12/3/10 and the Attending ENT Surgeon dictated the Operative Report on 12/20/10.

Patient #16, underwent an excision and wedge resection of the right ear on 6/10/11, a brief op note was present, however the Attending ENT Surgeon did not document an Operative Report.

Patient #18 underwent an excision of the right ear on 6/13/11 and the Attending ENT Surgeon dictated the Operative Report on 6/29/11.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on medical record review, interviews, and review of policies and procedures, the facility failed to ensure a post anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, for nine (#2, #7, #8, #9, #11, #12, #13, #14, #15) patients' records reviewed.

Findings include:

Patient #2's record indicated general anesthesia was administered on 3/18/11. There was no post anesthesia evaluation documented in the record.

Patient #7's medical record indicated general anesthesia was administered on 4/8/11. There was no post anesthesia evaluation documented in the record.

Patient #8's medical record indicated general anesthesia was administered on 2/11/11. There was no post anesthesia evaluation documented in the record.

Patient #9's medical record indicated general anesthesia was administered on 12/20/10. There was no post anesthesia evaluation documented in the record.

Patient #11's medical record indicated general anesthesia was administered on 3/25/11. There was no post anesthesia evaluation documented in the record.

Patient #12's medical record indicated general anesthesia was administered on 3/14/11. There was no post
anesthesia evaluation documented in the record.


Review of Patient #13's medical record indicated general anesthesia was administered on 2/25/11. There was no post anesthesia evaluation documented in the record.

Review of Patient #14's medical record indicated general anesthesia was administered on 1/5/11. There was no post anesthesia evaluation documented in the record.

Review of Patient #15's medical record indicated general anesthesia was administered on 12/3/10. There was no post anesthesia evaluation documented in the record.


Anesthesiologist #2 was interviewed in person on 7/18/11 at 11:10 AM. Anesthesiologist #2 said that patients with problems with anesthesia or as needed will be seen for an evaluation. Same day surgery patients are not routinely seen after anesthesia.

Review of a copy of the Department of Anesthesia's policy for post-anesthesia care did not evidence procedure to document a post evaluation in a patient medical record.