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Based on review of documentation and interviews, the Hospital failed to ensure that the medical staff was well organized and accountable to the governing body for the quality of the medical care provided to patients as evidenced by:

Background information:

The Facility reported the Patient presented for a scheduled colonoscopy on 11/10/10. The Patient had a history of diabetes, end stage renal disease pending kidney transplant, elevated cholesterol, peripheral vascular disease, and prior cerebral vascular accident. The Patient was classified as American Society of Anesthesiologists (ASA) III - Severe systemic disease, but not incapacitating. The Patient became unresponsive and required resuscitation 19 minutes after the procedure started. The Patient was transported to the hospital and pronounced after additional unsuccessful resuscitation efforts.

Findings included:

1) Review of the policy titled: Criteria for Patients Receiving Care at the Endoscopy Center, Section I. Purpose - indicated that the policy provided guidelines for which patients will receive care at the Endoscopy Center and which patients will be referred to the hospital setting for care.

Section V. Policy Statement - indicated that the free standing Endoscopy Center is to only perform procedures on patients classified as American Society of Anesthesiologist [ASA] classification I: Healthy patients with no medical problems and classification II: Patients with mild systemic disease .

Review of Section IV. Responsibility - indicated that it is the ultimate responsibility of the physician to determine if a patient is eligible for an endoscopic exam at the Endoscopy Center.

2) The Gastroenterologist Physician who performed the exam was interviewed in person on 12/8/10 at 10:05 am. The Gastroenterologist said s/he had been performing procedures at the Astrology Center for two years. The Gastroenterologist said s/he " was not aware he could not do ASA IIIs here " at the Gastroenterology Center. The Gastroenterologist said s/he had " no official orientation here [to the Gastroenterology Center]."

Review of the Pre-Procedural History and Physical dated 11/10/10 section on ASA classification written by the Gastroenterologist indicated the Patient was classified as an II, was crossed out and the classification checked as III with "Patient cleared for conscious sedation".

3) The medical Chief of the Gastroenterology Center was interviewed in person on 12/8/10 at 10:30 am. The Chief of the Gastroenterology Center said the classification levels are
"grey" and it is " difficult to determine the category " and the ASA guidelines are "open for interpretation." The Chief of the Gastroenterology Center said the policy was revised to add additional categories of complications (such as obstructive sleep apnea with CPAP, pre and post organ transplant and difficult airway/intubation) to ensure that patients with medical complications receive the procedure at a hospital setting.

4) The Chief of Anesthesiology was interviewed by phone on 12/8/10 at 4 pm. The Chief of Anesthesiology said that it is not unusual for one anesthesiologist to classify a patient at one level and another anesthesiologist to classify the same patient as another level. The Chief of Anesthesiology said that the free standing Center should not perform procedures on patients classified as ASA III and the guidelines should be clear to ensure patients receive the procedure in the appropriate setting.

Based on review of documentation, review of Hospital policy and interviews, the Facility failed to ensure that registered nurses supervised and evaluated the nursing care for each patient. Specifically, the nursing staff that performed the intake procedure at the Endoscopy Center did not ensure that patients classified as an ASA III did not undergo procedures at the Center according to policy and as a result, did not initiate the chain of command to involve Nursing Administration.

Findings included:

1) The Nurse who conducted the Admission Assessment on 11/10/10 was interviewed in person on 12/8/10 at 10:50 am. Nurse #1 said that s/he discussed the Patient's status with the Gastroenterologist: that the Patient was blind and on the kidney transplant wait list. Nurse #1 said this is the "typical population the doctor does." Nurse #1 said the doctor does the ASA classification and evaluates if it was OK to perform the procedure at the Center. Nurse #1 said that "ASA IIIs are done here " and it was " the responsibility of the doctor to make the determination of ASA level and if appropriate to do here." Nurse #1 said the "ASA IIIs are done here if they are stable." Nurse #1 was shown the Gastroenterologist's documentation of the history and physical and said s/he was not aware the Patient was classified as an ASA III. Nurse #1 said that the nurse who is assigned to the Patient for the procedure gets her admission form and that is all the contact she has with the patient for the day.

Nurse #1 said she was not aware the Patient was an ASA III that day, Nurse #1 said she did not initiate the chain of command because it was " the doctors determination and this was typical clientele for the doctor and s/he determined it was OK to do here." Nurse #1 said the Patient " looked good; vital signs were normal; breath sounds were clear and the history was an issue for me, but the doctor said it was OK [to do the colonoscopy here]." Review of Nurse #1 ' s Moderate Sedation & Procedure Record #1 dated 11/10/10 at 9:10 am indicated that the Patient was pre-kidney transplant; diabetes, right toe amputation, hypertension, blind, right arm fistula, right chest catheter/skin graft - " Discussed above condition with [Gastroenterologist]. In the section titled: Checklist - ASA status determined - documentation indicated that " MD - Yes. "

2) The Nurse who was assigned to the Patient for the colonoscopy was interviewed in person on 12/8/10 at 10:25 am. Nurse #2 said s/he reviewed the admission documentation and noted Nurse #1 signed that the Patient's medical diagnoses/condition was discussed with the Gastroenterologist. Nurse #2 said s/he felt the Patient was high risk, but said the Patient was visibly assessed to be stable on presentation. Nurse #2 said the Patient had stable vital signs and clear breath sounds. Nurse #2 said s/he reviewed the Patient's medical record and noted the Patient had an upper gastrointestinal exam in September under conscious sedation and tolerated it with no incident. Nurse #2 said the Patient was "at the moment, OK " for the procedure. Nurse #2 said the Patient received two doses of Fentanyl and Versed for the conscious sedation and they were talking throughout the induction period. Nurse #2 said that before the 10:09 vital signs were taken, the Patient's oxygen saturation monitor was not registering, so Nurse #2 thought it was due to poor circulation in the extremities and changed the site to the Patient's ear lobe, where no reading was obtained as well. The Patient was unresponsive, so 911 was called and the code was started. Nurse #2 said the ambulance team arrived and had a difficult time intubating the Patient as well. The Patient was transported to the hospital where further resuscitation was unsuccessful and the Patient was pronounced.

Nurse #2 was asked about the Policy regarding ASA classification and that Patients classified as III were not to undergo any procedure at the Center. Nurse #2 said that s/he
"thought we were allowed to take some ASA IIIs if they were stable" ; " it depended on the doctor and the evaluation of the status of the patient at the moment; " I ' m not sure."

As a result of Nurse #2's lack of understanding of the policy, Nurse #2 did not question the Gastroenterologist or initiate the chain of command to involve Nursing Administration regarding the safety of the Patient undergoing the procedure at the Center .