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Based on interview, and document review, the hospital was found not to be in compliance with the Conditions of Participation for Surgical Services (CFR 482.51) due to their failure to ensure proper sterilization of surgical instruments occurred, for 11 of 17 patients who underwent cataract surgeries during the month of August 2012. This deficient practice would affect the majority of patients who underwent cataract surgery at the hospital.

Findings include:

The hospital failed to have develop specific policies/procedures, failed to acquire manufacturer's instructions, to ensure surgical instruments were sterilized as recommended to prevent the risk of surgical infections.

During an interview with the Operating Room (OR) head registered nurse (RN)-A at 10:32 a.m. on 8/14/12, it was revealed that there were two ophthalmologists who routinely performed cataract surgeries at the hospital on the first and second Wednesdays of the month. According to RN-A, each of the physicians was accompanied by a representative from Sightpath (a medical supply provider of intraocular surgical equipment). RN-A stated the hospital had 1 cataract tray for each of the ophthalmologists and the Sightpath representative would bring two additional wrapped trays of surgical instruments to use for the day of the surgery. RN-A stated that between surgical cases the surgical staff, including RN's, surgical techs (ST), and the sterile processing department's licensed practical nurse (LPN), would wash the instruments, place the unwrapped instruments on a tray, and flash sterilize them at 270 degrees for ten minutes. RN-A verified the instruments were not necessarily allowed to dry prior to use in the next case. He further added that the hospital was aware they were not supposed to flash sterilize this frequently.

At 2:05 p.m. on 8/15/12, a Sightpath Operation Manager was interviewed via telephone. He indicated that it was the hospital's preference to do flash sterilization of the cataract trays. When was asked whether the instruments were taken through a full cycle of sterilization or terminal cleaning, the Sightpath Operation Manager stated it depended on the individual hospital, how they wanted it done and what their policies dictated.

The hospital did not have policies specific to sterilization of equipment used for cataract surgeries. The only policy provided was entitled, Sterilization in the Practice Setting revised 8/08. It was a general policy which included: "Flash sterilization should be used only in carefully selected clinical situations. 1. In case of emergency 2. When sterilized items can be directly delivered to point of use. 3. Aseptic handling during transfer can be assured. 4. An auditing system is in place...5. Manufacturer's instructions for operating flash sterilization will be followed. ..."

The manufacturer's recommendations for the cataract trays, surgical utensils and the sterilizer used by the hospital, were requested but nothing further was submitted during the survey. Post survey (8/21/12) RN-A submitted the following information by email: "After doing some digging and receiving little help from the manufacturer, I have decided to change our practice to meet standards. Regardless of our history with flash sterilization and low infection rates and the info (information) from manufacturers, I believe we can streamline our processes and improve our care".

Based on interview and record review, the hospital failed to ensure specific policies and procedures for cataract surgery equipment sterilization were developed, and failed to ensure adequate inventory of equipment to ensure safe surgical interventions could be provided. This had the potential to affect the majority of patients who undergo cataract surgery at the hospital.

The findings include:

Review of the surgical logs revealed 17 patients had undergone cataract surgery between 8/1 and 8/15/12.

During an interview with the operating room head registered nurse (RN)-A at 10:32 a.m. on 8/14/12, it was revealed that there were two ophthalmologists who routinely performed cataract surgeries at the hospital. RN-A stated the physicians were accompanied by a representative from Sightpath (a medical supply provider of intraocular surgical equipment).
RN-A stated the hospital had 1 cataract tray for each of the ophthalmologists and the Sightpath representative would bring two additional wrapped trays of surgical instruments to use for the day of the surgery. RN-A stated they flash sterilized the cataract trays and instruments between surgeries as they routinely scheduled 8-12 cataract procedures on the days they were conducted as they had limited equipment. RN-A said they routinely scheduled cataract surgeries to be conducted on the First and second Wednesdays of each month and the second Thursday of each month.

The hospital had not developed policies specific to sterilization of equipment used for cataract surgeries when they routinely used flash sterilization techniques. The only policy provided was entitled, Sterilization in the Practice Setting revised 8/08. It was a general policy which included: "Flash sterilization should be used only in carefully selected clinical situations. 1. In case of emergency 2. When sterilized items can be directly delivered to point of use. 3. Aseptic handling during transfer can be assured. 4. An auditing system is in place...5. Manufacturer's instructions for operating flash sterilization will be followed. ..."

Based on observation, interview and document review, the hospital failed to ensure that 5 of 11 inpatient surgical patients reviewed, had post anesthesia assessment to ensure proper anesthesia recovery following surgery.

Findings include:

Surgical patients' records lacked documentation to support that the patients had been evaluated for proper anesthesia recovery.

Not all surgical patients had a post anesthesia evaluation assessment of their systems including: respiratory function, cardiovascular function, mental status, temperature, pain, nausea and vomiting, and postoperative hydration.

P1 had undergone an appendectomy under general anesthesia on 8/10/12 late in the evening. The documented end time of anesthesia was 12:45 a.m. The certified registered nurse anesthetist (CRNA)-B documented the post-anesthesia note at 12:45 a.m., the same time the anesthesia ended.

P2 underwent a surgical procedure for a loop colostomy under general anesthesia on 8/9/12. The anesthesia stop time documented for this case was 10:00 a.m. CRNA-A documented the post-anesthesia note at 9:54 a.m., 6 minutes prior to the documented end time of anesthesia.

P3 underwent a surgical procedure for right hemi-colectomy under general anesthesia on 8/7/12. The anesthesia stop time documented for the case was 12:50 p.m. CRNA-A documented the post anesthesia note at that same time the anesthesia administration ended.

P8 underwent a laparoscopic cholecystostomy with chol-angiogram surgical procedure under general anesthesia on 8/3/12. Anesthesia stop time documented for the case was 8:20 p.m.. CRNA-A documented the post anesthesia note at 8:15 p.m. or 5 minute prior to the documented anesthesia stop time.

P13 had an appendectomy under general anesthesia on 4/10/12. The anesthesia record indicated the anesthesia ended at 8:30 p.m. and the post-anesthetic evaluation was conducted at that same time, immediately following the discontinuation of anesthesia in the operating room.

The facility's policy, Post Anesthesia Care Standards for the CRNA, was reviewed. Under section VI directions included: "All patients will receive a post anesthetic visit to assess their outcomes and address any questions. This will be documented on the anesthesia record."

During interview at 1:13 p.m. on 8/15/12, the director of nursing verified these Post Anesthesia Notes were conducted prior to or immediately following surgery, which did not allow for proper and adequate evaluation of the post surgical status of the patients.

During interview with RN-A at 2:15 p.m. on 8/15/12, he agreed that the above identified post anesthesia notes would not allow for adequate evaluation of the surgical patient's post anesthesia status.

During interview at 12:13 p.m. on 8/15/12 with CRNA-A and at 12:20 p.m.on 8/15/12 with CRNA-B verified that the current Post Anesthesia Note generated from the computer does not include evaluation of the following for the surgical patient: respiratory function, including respiratory rate and rhythm, airway patency and oxygen saturation level; cardiopulmonary status; documented vital signs including temperature, pulse, respiration and blood pressure; follow up observations or any complications which had occurred during the post anesthesia recovery.