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180 FLOYD AVENUE

ROCKY MOUNT, VA 24151

OPERATING ROOM POLICIES

Tag No.: A0951

Based on interviews and document review, it was determined the facility staff failed to ensure written policies and procedures directing surgical care addressed housekeeping / cleaning requirements.

The findings include:

The facility staff was unable to provide a written policy / procedure that addressed housekeeping / cleaning for the operating rooms.

During the review, on the morning of 6/2/16, of facility policy's directing surgical care, the surveyor asked to see the policy that addressed operating room housekeeping guidance. Employee #3 (a clinical effectiveness registered nurse) provided the surveyor with a copy of a "Environmental Services Surgery Cleaning Checklist" and a copy of a facility policy / procedure entitled "Endoscopy Post-Procedure Room Cleaning". Employee #3 reported no policy was found that addressed the cleaning of operating rooms.

During a meeting on the afternoon of 6/2/16, the absence of a facility policy / procedure to provide guidance for the cleaning of operating rooms was discussed for a final time during a survey team meeting with facility staff members including Employee #3 and Employee #4 (a registered nurse with surgical department management responsibilities); no additional information was provided to the survey team.

INFORMED CONSENT

Tag No.: A0955

Based on interviews and document review, it was determined the facility staff failed to ensure the informed consent for a procedure correctly detailed the procedure performed for 1 of 6 patients sampled for procedure and/or surgery review (Patient #1).

The findings include:

Patient #1's informed consent for a colonoscopy failed to include that the physician was going to remove a condyloma.

Patient #1's consent form included the following statement: "The doctor has explained the procedure(s) to me and I understand the nature and the purpose of the procedure to be: colonoscopy". The consent form did not include a statement for the removal of a condyloma.

The following information was found in a facility policy entitled, "Patient Decision Making - Informed Consent to Treatment": "INFORMED CONSENT OR REFUSAL means a decision by a patient to consent to or refuse medical treatment after being provided with the following information and having questions answered satisfactorily: ... (2) The nature and purpose of the proposed treatment. (3) The risks, benefits, and side effects of the proposed treatment, including potential problems related to recuperation. (4) The possible alternative treatments, including risks, benefits, and side effects."
This policy also included the following: "It is the legal responsibility of the physician or practitioner who is credentialed to perform the procedure or treatment to provide to the patient prior to the proposed procedure or treatment, the information necessary for the patient to give informed consent or refusal ... The responsible physician or practitioner must complete and sign the appropriate (hospital name omitted) consent form."

Review of Patient #1's history and physical dated 4/14/16 at 7:31AM revealed the following information:
- "DATE OF SURGERY: 04/14/2016"
- "HISTORY OF PRESENT ILLNESS: A (patient identification information omitted) saw me in the office on April 6th. (His/Her) last colonoscopy was in 2014 at which time (he/she) had 5 polyps removed. One of these had dysplasia and I had recommended a followup [sic] colonoscopy in 3 to 6 months and (he/she) did not have this done. At this time, we have agreed to proceed with a bowel prep and a colonoscopy."
- "REVIEW OF SYSTEMS: ... GASTROINTESTINAL: No nausea, vomiting, diarrhea, constipation, abdominal pain, melena, hematochezia, jaundice, dyspepsia, change in bowel habits, incontinence. Genitourinary: No dysuria, hematuria, discharge, frequency, urgency, incontinence, nocturia..."
- IMPRESSION AT THIS TIME: History of colon polyps, one with dysplasia."
- "Plan: The patient is scheduled for a bowel prep and colonoscopy, monitored and deep sedation as an outpatient on April 14th."
- "I have examined the patient and there are no changes or additions to the H&P Examination including Heart and Lungs assessment.4/14/2016 8:20 AM" [sic]

Review of Patient #1's procedure note dated 4/15/16 at 11:11AM included the following: "PROCEDURE: Colonoscopy with polypectomies snared, 2 in the descending, 4 or 5 in the sigmoid, and excision of condylomata with subsequent cauterization ... DESCRIPTION OF PROCEDURE: ... To begin the exam, (he/she) did have condyloma acuminate. These have been biopsied in the past and was AIN1. We discussed multiple times about removing these and at this time I informed the OR staff that I would be removing these at the completion of the procedure ... I did not have the consent for excision of the condylomata on the operative consent, but the patient and I had discussed this verbally and (he/she) had given permission for this to be done."

During an interview with the physician on the afternoon of 6/1/16, the physician reported the removal of the condyloma was not on the informed consent form. The physician reported he/she had discussed the removal of the condyloma with Patient #1 and had received verbal consent. The physician stated if he/she had not received verbal consent from the patient he/she would not have removed the condyloma.

The following information was found in a written statement dated 5/18/16 and signed by Patient #1: "The warts I call these [sic] were removed by (doctor's name omitted) as this had been discussed before my colonospy [sic] and I had told (him/her) to do whatever was necessary about this procedure."

This is a complaint deficiency.