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Based on observation, interview and record review, the facility failed to ensure Operating Room (OR) staff followed their policy and procedure related to the accounting and inspection of vendor instrument trays.

The hospital also failed to ensure that all physicians performing upper (esophagus and stomach) and lower (bowel) endoscopy wore appropriate eye protection. This resulted in the potential for the transmission of infection agents between patients and staff.


1. The Vice President of Clinical Services (VPC) was interviewed on 9/14/16 at 9:30 A.M. The VPC stated that loaner instrument trays from approved vendors are requested in advance of a patient's surgery. The vendor instrument trays are then reviewed prior to surgery, using the tray list, by the Circulating Nurse, an Advanced Clinician nurse and a Scrub Tech. The vendor is also required to be present during the case. According to the VPC, OR staff are expected to follow the same policy for counting vendor instrument trays as they do hospital instrument trays. The VPC stated, "It is the responsibility of OR staff to ensure everything is accounted for."

On 9/14/16 at 12:35 P.M., an observation was conducted in Operating Room (OR) 6 during Patient 4's surgery. The patient was undergoing a right hip deep hardware removal and revision of total hip arthroplasty.

During the surgery observation, the Director of Surgical Services (DSS) stated during an interview at 12:45 P.M., that Vendor 1 and the Scrub Tech (ST) would count the loaner tray at the end of surgery when the dressing is being placed on the patient.

At the end of the surgery, Vendor 1 was observed holding a white piece of paper, while speaking to the Circulating Nurse. According to the OR Charge Nurse, Vendor 1 and the Circulating Nurse were reviewing the inventory list of the loaner instrument tray. However, the loaner tray was located on a back surgical table, away from the nurse and vendor. Vendor 1 then walked over to the back surgical table, looked at the loaner tray, then turned around and placed a white sheet of paper on another empty surgical table. When interviewed, Vendor 1 stated the paper was an inventory list of the loaner tray. Vendor 1 further stated he was counting the equipment in the loaner tray to compare the items of hardware used during Patient 4's surgery and what remained in the loaner tray. Vendor 1 counted the items in the loaner tray independently.

During an interview on 9/14/16 at 1 P.M., the DSS acknowledged that Vendor 1 counted the items in the loaner tray independently. The DSS further stated the vendor should have looked at the tray during the count with the circulating nurse.

According to the facility's policy, Intraoperative Counts, dated 4/16, "Sponge, sharp, miscellaneous items and instrument counts are the dual responsibility of the scrub person and the RN Circulator with full accountability for the process." The policy further indicates, "Each tray of instruments shall be counted by stating the name and the number of each type of instrument or instrument part."

"The instrument inventory sheet included with each tray shall be retained and used by the circulating RN to document the initial, ongoing and closing instrument counts."

2. The Endoscopy Lab was toured on 9/14/16 at 3:00 PM. No procedures were in progress at the time. The Director of GI Lab was interviewed regarding the use of Personal Protective Equipment during endoscopy. She stated that the technicians and other hospital staff wore gowns, gloves, and masks with clear plastic eye shields. Most physicians followed the same practice but 3 of the 15 practitioners did not wear eye shields.

A hospital policy was provided entitled, "Blood & Body Fluid Exposure Control Plan, effective 11/15. "Page 4, Section D, 1, 3 states, "Wear facial protection including goggles or eye shield and mask when your face is likely to be splashed with blood or body fluids."

The hospital's surgical staff had identified the Association of peri-Operative Registered Nurses as their reference for surgical care. AORN Recommendations for Eye Safety in the OR posted [DATE], states: "The AORN recommends specific eye protection equipment in operating rooms to which aid in preventing conjunctiva bacterial and viral infections transmissible by blood, saliva, and other bodily fluids. For instance, along with gloves, gowns, masks and respirators, the AORN elaborates on eye protection as follows:

Surgical Eyewear
To protect against blood and other infectious material spatter, splashes, droplets and spray
Eye protection includes:
properly fitting goggles including reusable or disposable goggles (eye shields)
masks containing eye shields
chin-to-crown and ear-to-ear face shields,
full-face respirators,
personal glasses with side shields"
Based on interview and document review, the hospital's Department of Anesthesia failed to ensure that patients in the Emergency Department (ED) receiving deep sedation/anesthesia were monitored by staff qualified for this task. Patients receiving Propofol, Etomidate and Ketamine, all considered deep sedation or anesthesia, were monitored by a registered nurse with competency in moderate sedation administration and monitoring. The nurses were not privileged for deep sedation. This resulted in the potential for patients who unintentionally slipped into deep sedation or anesthesia to suffer harm or death.


The ED was toured on 9/13/16 at 1:40 PM. ED Physician 1 was observed sitting at the nursing station. She was questioned regarding the agents used for procedural sedation in the ED and replied that Fentanyl and Versed (moderate sedatives) were used for most cases but Propofol, Etomidate and Ketamine were used when the physician felt it was indicated. For these agents, the physician would administer the drug and begin the procedure. The nurse would monitor the patient. Nurses were privileged for the administration and monitoring of moderate sedation only, not general anesthesia, monitored anesthesia care, or emergency airway management.

The manufacturer's package insert for Propofol states, "For general anesthesia or monitored anesthesia care (MAC) sedation, Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardio-respiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients."

The hospital provided a policy dealing with moderate sedation. "Sedation-Monitoring & Management of the Patient Receiving Moderate Sedation, effective 4/15, states, "No interventions are required to maintain a patent airway. "It also lists "medications typically used in moderate sedation "as follows, "Diazepam (Valium), Midazolam (Versed), Fentanyl, Meperidine (Demerol), Morphine, Hydromorphone (Dilaudid) and Chloral Hydrate. "Propofol, Etomidate and Ketamine are not listed. A policy for deep sedation was requested but not provided.

The American Association of Nurse Anesthetists (AANA) and the American Society of Anesthesiologists (ASA) guidelines states: "AANA-ASA Joint Position Statement Regarding Propofol Administration: Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonistic medications, agents such as propofol require special attention. Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. This restriction is concordant with specific language in the propofol package insert, and failure to follow these recommendations could put patients at increased risk of significant injury or death. Similar concerns apply when other intravenous induction agents are used for sedation, such as thiopental, methohexital or etomidate."

The Chief of Anesthesiology was interviewed 9/14/16 at 2:05 P.M. He stated that as the Chairman of the Department of Anesthesiology he oversees all moderate sedation. When questioned on the use of Propofol, Etomidate and Ketamine in the ED, with monitoring by an RN, he stated he was aware of the practice. He said that he agreed that having monitoring of these agents by a person trained in anesthesia was a better practice.