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Based on findings from facility document review, medical record (MR) review, and interview, the hospital failed to protect each patient's right to safe care by 1) allowing an unlicensed and uncredentialed observer in the Operating Room (OR) to participate in the intubation of at least one patient (Patient A), 2) not performing and undertaking corrective actions when the occurrence was reported up through the hospital's chain of command, and 3) not having in place informed consent procedures that allow each patient the right to refuse various aspects of care. This Immediate Jeopardy situation was identified on 12/15/14 and removed prior to the completion of the survey on 12/16/14. See findings in Tags A 131, 144, and 940.

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Based on findings from facility document review, medical record (MR) review and interview, the hospital failed to have complete informed consent procedures in place for surgery and anesthesia which provided patients the option to refuse various aspects of care. This was confirmed in 9 of 9 MRs reviewed (Patients B through J).

Findings include:

--On 12/15/14, review of the hospital's consent forms titled "Operative/Procedure Consent," last revised 9/2010, and "Anesthetic Consent," last revised 6/2012, revealed that the 2 consent forms contained some or all of the following text:

"I have been informed of and consent to the potential need for blood transfusion. The risks, benefits and alternative treatments, if any, have been explained to me by my physician. ... For the purpose of advancing medical education, I consent to the admittance of observers to the room in which the procedure/treatment is performed (both consents)."

"I give permission for technical personnel to be present during my procedure or operation for technical support under supervision of my physician (operative/procedure consent)."

These consent forms did not contain instructions or provisions that allowed a patient or their representative the option of refusing to consent to the presence of observers or technical personnel or the administration of blood during procedures.

--The hospital P&P titled "Informed Consent- General and Medical, Treatment, Operative, Diagnostic, Dental Procedures, Anesthesia, and Blood/ Blood Products," last revised 9/2012, indicated that a signed and witnessed Informed Consent from all patients or representatives must be obtained prior to performing any medical treatment, operative and invasive procedures, dental or anesthesia procedure, as well as administration of blood or blood products. The policy did not contain instructions on a process to allow and document patient refusal of observers, technical personnel, or blood administration during surgery or a procedure.

--Per review of the MRs of 9 surgical patients who underwent surgery with an observer present during the procedure on 7/30/14 and 7/31/14 (Patients B through J), in all 9 the consent forms referenced above were present and signed in the MR. For example:

* Patient B was admitted to the hospital on 7/30/14. Consent forms signed by the patient on 7/29/14 for an upper endoscopy and for administration of anesthesia during the upper endoscopy were present in the medical record. The consent forms indicated an observer could be present during the procedure and that blood may be needed. The forms lacked provision for the patient to refuse these aspects of care.

* Patient C was admitted to the hospital on 7/30/14. Consent forms signed by the patient on 7/30/14 for a cystoscopy and transurethral resection of the prostate and for administration of anesthesia during the surgical procedure were present in the medical record. The consent forms indicated an observer could be present during the procedure and that blood may be needed. The forms lacked provision for the patient to refuse these aspects of care

* Patient D was admitted to the hospital on 7/31/14. Consent forms signed by the patient on 7/31/14 for FESS (functional endoscopic sinus surgery) septoplasty and turbinate reduction, and for administration of anesthesia during the surgical procedure were present in the medical record. The consent forms indicated an observer could be present during the procedure and that blood may be needed. The forms lacked provision for the patient to refuse these aspects of care

--During interview with the hospital's Director of Risk Managment on 12/15/14 at 4:30 pm, he/she acknowledged the finding that the hospital consent forms did not provide patients the option to refuse aspects of care.

Based on findings from facility document reviews and interviews, the hospital failed to protect a patient's right to receive care in a safe setting when it allowed an unlicensed and uncredentialed observer in the Operating Room (OR) to participate in the intubation of a patient (Patient A), and when it did not investigate and undertake corrective actions following a report of the occurrence up the hospital's chain of command.

Findings include:

--Review on 12/12/14 of the hospital's policy and procedure (P&P) titled "Job Shadowing," last reviewed 4/2014, revealed the policy applied to anyone requesting a job shadowing experience and did not apply to healthcare students requesting academic internship. The P&P noted patients will be given the opportunity to consent to the presence of a job shadowing individual and the patient will always have the right to decline. It also noted the job shadowing individual will never provide direct patient care and may only observe the healthcare professional's work.

--Per interview with the Vice President of Medical Affairs (VPMA) on 12/12/14 at 2:30 pm, he/she recalled that a question was raised some time ago regarding what an observer / job shadower could or could not do in the OR. The VPMA recalled that it involved Anesthesiologist #1 and an observer, but could not recall the specific question or concern involved. The VPMA did not speak with Anesthesiologist #1 regarding the concern and stated that at the time, he/she thought it was a hypothetical situation.

--Per interview with Staff #1 on 12/15/14 at 7:15 am, Anesthesiologist #1 had an observer / job shadower with him/her during an operative procedure sometime during the past year in 2014 (he/she could not recall specific date). The observer was thinking about going to medical school. While in the OR Staff #1 saw Anesthesiologist #1 holding the laryngoscope to open the airway while the observer inserted the endotracheal tube into the patient's (Patient A's) trachea. Immediately after the procedure, he/she (Staff #1) reported the occurrence to the Charge Nurse.

--During interview on 12/15/14 at 7:35 am with Staff #2, an OR Charge Nurse, he/she acknowledged that on 7/31/14 an OR staff member reported to him/her that Anesthesiologist #1 allowed an observer to intubate a patient. Staff #2 indicated he/she reported the occurrence to the Vice President of Nursing Services (VP Nsg) the same day. Staff #2 stated that he/she was instructed by the VP Nsg to speak with Anesthesiologist #1 about this situation to make sure he/she understood what an observer could and could not do, i.e., they were not to have any direct patient care. Staff #2 spoke to Anesthesiologist #1 the same day. During their conversation Anesthesiologist #1 indicated the observer was under his/her jurisdiction but probably shouldn't have been allowed to participate in the intubation. Staff #2 also reported this to the now former OR Nurse Manager who "was shocked" and stated that job shadowers/observers were there to observe only.

--Per interview on 12/15/14 at 9:30 am with the VP Nsg, he/she spoke with Anesthesiologist #1 and asked him/her whether the reported intubation occurrence had happened. Anesthesiologist #1 acknowledged that it had. The VP Nsg indicated he/she informed the VPMA and Chief Executive Officer (CEO) about the situation, but was not certain of the date.

--Per interview of the Director of Risk Management and Director of Quality Improvement on 12/15/14 at 1:00 pm, they were not aware of the occurrence and actions described above, and acknowledged an investigation with corrective actions was not undertaken.

--Per review of the credentials and performance improvement file of Anesthesiologist #1, it lacked any reference to him/her allowing an observer to participate in the intubation of a patient in the OR.

--Per interview with the CEO on 12/15/14 at 4:15 pm, the VP of Nursing informed him/her of an incident in the OR involving Anesthesiologist #1 allowing an observer to provide care and that Anesthesiologist #1 admitted that the incident occurred. The CEO did not recall hearing specifically that the observer had intubated a patient, and acknowledged lack of documentation regarding the incident and any hospital investigation. The CEO indicated hospital staff "dropped the ball" in this case.

--The hospital P&P titled "Chain of Command," last revised 5/2014, described the reporting chain of command staff should follow when concerned about an occurrence that is not being adequately addressed.

--All findings above illustrated staff noncompliance with the hospital P&Ps in place to ensure each patient's right to safe care in the OR and to ensure appropriate attention to reports of unsafe patient care. (See findings in Tag A940 regarding the Immediate Jeopardy identified in this matter.)









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Based on findings from facility document review and interview, the hospital failed to ensure its surgical services were provided in accordance with acceptable and safe standards of practice. Specfically, an unlicensed, uncredentialed observer performing job shadowing in the operating room (OR) participated in a patient intubation procedure. When this occurrence was reported up the chain of command, hospital administrative staff failed to require an investigation in order to determine the extent of corrective actions needed to ensure safe surgical practices in the OR. In connection with these findings, on 12/15/14 during the survey the New York State Department of Health (DOH) staff declared Immediate Jeopardy (IJ). The IJ was removed subsequent to the hospital implementing acceptable corrective actions prior to the completion of the survey on 12/16/14.

Findings include:

--Per interview with Staff #1 on 12/15/14 at 7:15 am, Anesthesiologist #1 had an observer / job shadower with him/her during an operative procedure sometime during the past year in 2014 (he/she could not recall specific date). The observer was thinking about going to medical school. While in the OR Staff #1 saw Anesthesiologist #1 holding the laryngoscope to open the airway while the observer inserted the endotracheal tube into the patient's (Patient A's) trachea. Immediately after the procedure, he/she (Staff #1) did report the occurrence to the Charge Nurse.

--During interview on 12/15/14 at 7:35 am with Staff #2, an OR Charge Nurse, he/she acknowledged that on 7/31/14 an OR staff member reported to him/her that Anesthesiologist #1 allowed an observer to intubate a patient. Staff #2 indicated he/she reported the occurrence to the Vice President of Nursing Services (VP Nsg) the same day.

--Per interview on 12/15/14 at 9:30 am with the VP Nsg, he/she spoke with Anesthesiologist #1 and asked him/her whether the intubation occurrence happened. Anesthesiologist #1 acknowledged that it had. The VP Nsg told Anesthesiologist #1 that it could not happen again. Anesthesiologist #1 indicated that the observer was under his/her supervision when the intubation took place, took full responsibility and said it would not happen again.

--During interview with Anesthesiologist #1 on 12/15/14 at 12:10 pm, when questioned about the intubation circumstances described above he/she acknowledged there was an occurrence where an observer participated in patient care but he/she didn't remember the details. Anesthesiologist #1 was not aware the hospital had a policy and procedure regarding job shadowing.

--Per interview of the Director of Risk Management and Director of Quality Improvement on 12/15/14 at 1:00 pm, they were not aware of the occurrence and actions described above, and acknowledged an investigation with corrective actions was not undertaken.

--At 1:00 pm on 12/15/14, the CEO, the VPMA, the Director Of Quality Improvement, the Director of Risk Management, and the VP Nursing were informed that the findings above and in Tag A 144 represented IJ. At 5:00 pm the hospital administrative staff provided an acceptable corrective action plan to the Department of Health (DOH) surveyors.

The corrective action plan entailed immediate cessation of job shadowing in the perioperative suite (i.e., in the OR, endoscopy unit, ambulatory surgery unit). Policies and procedures were revised to ensure all staff understood that patient contact by observers in the OR (e.g., sales representatives, nursing and physical therapy students) and anywhere else in the hospital (including job shadowers) is not allowed. A form was developed for observers to sign indicating awareness patient contact is not allowed. Perioperative staff, including physicians, were educated face-to-face in these changes. Staff in all other patient care departments were educated by use of e-mail correspondence. Health stream education regarding reporting of adverse events and following chain of command process was developed for completion by all staff. Anesthesiologist #1 was counseled and a corresponding letter was placed in his/her quality improvement file at the hospital.

--On 12/16/14 at 3:00 pm, DOH staff completed its review of the P&P and form changes made by the hospital and related education materials, and interviews of 10 staff (Staff #s 2-9, and the Directors of Risk Management and Quality Improvement) confirming the hospital's implementation of its corrective actions. The IJ was deemed removed.

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Based on findings from facility document review, medical record (MR) review and interview, in 18 of 25 MRs reviewed (Patients B, and D through U), the surgical and anesthesia consent forms lacked documentation of the time the consent was obtained and 1 of 25 MRs (Patient S) lacked consent for anesthesia.

Findings include:

--Per review of the hospital forms titled "Anesthetic Consent" and "Operative/Procedure Consent," last revised 6/2012 and 9/2010, they required documentation of the times the provider (surgeon, anesthesist), the patient and the witness sign the form.

--Review of the MRs for Patients B, and D through U, revealed each lacked the time the surgical and/or anesthesia consents were signed by the surgeon, patient and/or witness. For example:

* On 7/31/14 Patient F was admitted to the hospital for dysphasia, hoarse voice. On 7/31/14, Patient F, a surgeon, anesthesiologist, and a nurse witness signed a consent form for esophagoscopy, suspension microlaryngoscopy and injection botox, radiesse. It lacked the times the surgeon and anesthesiologist had signed the form.

* On 6/12/14 Patient M was admitted to the hospital for treatment of a right mandibular mass. On 6/12/14, Patient M, a surgeon and a nurse witness signed a consent form for excision of right submandibular mass, excision right lymph node. The consent lacked the time the surgeon had signed the form.

* On 5/30/14 Patient N was admitted to the hospital for a hernia repair. On 5/2/14, Patient N, a surgeon and a medical assistant witness had signed a consent form for repair of incisional hernia with mesh. The consent form, present in the medical record, lacked the times each person had signed the form.

--Also, review of Patient S's MR revealed that although he received general anesthesia during surgery on 7/31/14, his MR lacked an anesthesia consent form signed by him and the provider administering anesthesia.

--During interview on 12/12/14 at 1:45 pm, these findings were acknowledged by the Interim Operating Room Nurse Manager.

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Based on findings from facility document review, observation, and interview, in 1 of 1 anesthesia cart observed in the operating room (OR), the hospital had failed to remove 3 expired and/or undated multidose vials.

Findings include:

--The hospital's policy and procedure titled "Expiration Dating of Medications," last revised 2/2013, indicated that multidose vials should be discarded 28 days after opening and dated with date of expiration.

--Per observation of the anesthesia cart in Operating Room #4 on 12/12/14 at 11:30 am, 1 open multidose 20 milliliter vial of Labetolol was noted to be outdated (date of expiration 11/18/14) and 1 open multidose 20 milliliter vial of Atropine was labeled with an open date of 10/22/14 (outdated and not labeled with expiration date per policy). The anesthesia cart also contained (1) multidose 2 milliliter vial of Glycopyrrolate that was open and not dated. The vials were discarded

-- During interview with the Director of OR Education on 12/12/14 at 11:30 am, the above findings were acknowledged.