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Based on policy and procedure review, document review, medical record review, and staff interviews, it was determined the facility failed to maintain an infection control program that minimizes risk of infections associated with procedures performed by the facility as evidenced by the following:

1. Facility failed to follow accepted standards of sterilization and disinfection of surgical instruments. This practice potentially exposes patients unnecessarily to infectious diseases.

2. Facility failed to have a sterilization and disinfection of sterile instruments policy reflecting current practice standards and guidelines.

4. Facility failed to have a policy and procedure for testing and treatment of patients exposed to bloodborne pathogens. Delayed disclosure can result in transmission of infectious disease to the exposed patient when preventative medications are not received in a timely manner.

5. The facility Infection Prevention Program failed to ensure compliance with sterilization and disinfection practices in the OR related to immediate use steam sterilization (IUSS) and Steris 1E sterilization of surgical instruments. Failure to ensure compliance can result in surgical patients being potentially exposed to infectious diseases.

See A749

Based on policy and procedure review, document review, medical record review, and staff interviews, it was determined the facility failed to maintain an infection control program that minimizes risk of infections associated with procedures performed by the facility as evidenced by the following:

Findings included:

On 02/05/18 a review of the facility December 2017 incident reports showed an event on 12/26/17 related to a break in sterile technique during the surgery of Patient #5. The incident report showed the Registered Nurse First Assist (RNFA) discovered sterilizer strips lying on a computer workstation in the OR after the surgery was over. The strip showed that the laparoscope used during surgery had gone through sterilization in a Steris 1E sterilizer and had not met sterilization parameters. The surgeon was notified immediately of the event. Manager comments showed a laparoscope had been placed in a Steris IE sterilizer and had not met all the required parameters for sterilization before being placed in the sterile field and used on Patient #5. The chemical indicator in the instrument tray turned color, but the heat, temperature, and exposure time failed.

On 02/06/18 at 1:45 PM a tour was conducted of the OR accompanied by the Surgical Services Manager, Infection Prevention (IP) Manager, and the Surgical Services IP. During the tour, observations were made verifying there were 10 autoclave steam sterilizers and 4 Steris 1E sterilizers located in the OR. During the tour, surgical instruments were observed being steam sterilized. The autoclave steam sterilizers and Steris 1E sterilizer were observed to be in the same room as the sink where surgical instruments are decontaminated and cleaned. This process was confirmed by the surgical services manager and IP manager while on tour.

On 02/ 07/18 at 11:00 AM, an interview with the Surgical Services Assistant Manager revealed a surgical technician (ST) removed the bariatric scope from the Steris 1E, along with the tape that showed if sterilization parameters were met. The ST then placed the scope and ticket on the RN circulator's side table in the OR and the surgeon subsequently used the scope on Patient #5. After the procedure, it was discovered by the Registered Nurse First Assist (RNFA), that the sterilizer tape parameters had not been met. The RNFA then informed the RN circulator. The RN circulator then called the Surgical Services Assistant Manager to make her aware of the incident. After receiving report of the incident from the RN circulator, the assistant manager failed to call the surgical services manager, SPD manager, administrator on duty (AOD), or the Infection Preventionist, as required by facility policy. The assistant manager asked the RN circulator to fill out an incident report (pink slip) and put the incident report in an envelope in the incident reports basket. The pink slip incident form was filed on 12/26/17 by the RN circulator and placed into the incident basket for manager review. The manager and assistant manager returned to work on 12/27/17; however, the incident report was not reviewed and entered into the incident reporting system (Prism) until the afternoon of 12/28/17, by the Assistant Manager of Surgical Services. Once the incident report was entered into Prism, the Risk Manager (RM) received the report immediately.

An interview with the Surgical Services Manager on 02/05/18 at 11:15 AM revealed she had not reviewed the incident report upon returning to work on 12/27/18.

An interview conducted with the facility Risk Manger (RM) on 02/05/18 at 11:15 AM, revealed she was not made aware of the incident by the Surgical Services Assistant Manager or AOD on the date of the event. However, she did receive an incident report 12/28/17. The RM stated she did not perform a detailed investigation related to the causes of the incident.

An interview on 02/07/18 at 10:55 AM with the RN circulator involved with the incident revealed she was unaware of who placed the bariatric scope and sterilizer strip on her stand. The RN circulator confirmed she had not checked the sterilization strip to ensure parameters had been met prior to the scope being used on Patient #5.

On 02/07/18 at 2:10 PM, an interview with the ST involved with the incident, revealed she had removed the scope from the sterilizer, along with the sterilization strip, and placed both on the RN circulators stand. The ST confirmed she had not checked the sterilization strip to ensure parameters had been met prior to removing the scope from the sterilizer.
Review of the policy entitled, Surgical Services, # BC-IPC-152, revised 10/17, showed the following:
1. All scopes will be decontaminated and processed by high-level disinfection or terminally sterilized following each use as instructed by the manufacture for their purpose.
2. Immediate use steam sterilization (gravity or pre-vacuum) is used in the OR as a technique to process unsterile materials or reprocess items that have become contaminated.
3. Implantable devices will be sterilized by IUSS only when not available from the manufacturer in a sterile state or due to time constraints in which the Sterile Processing Department (SPD) is unable to perform the instrument sterilization. A rapid readout biological indicator will be initiated, documented and logged with results.
4. IUSS will be documented on the intraoperative Electronic Health Record. Documentation includes the cycle type, item description, reason for IUSS, sterilizer location, load number, and that parameters were met. Printouts will be maintained and stored.
5. At the conclusion of the sterilization cycle, the RN/Surgical tech (ST) is responsible for confirmation of the sterilization process before being removed from the sterilizer. The RN/ST must verify the chemical indicator strip has changed to the appropriate color and checking the sterilizer printout for verification of the correct cycle date and time, correct temperature reached, correct sterilization and dry time completed, and type of container used.
6. Following verification, the RN/Surgical technician will initial the sterilizer tape to indicate that parameters necessary to sterilize the contents for the cycle were reached. If not reached, the process must be repeated until they are reached or the goods not used.
7. When questionable materials have been already used in patient care, the SPD Manager/Charge Nurse, physician and Infection control team must be notified verbally and via occurrence report so that close patient monitoring and early intervention can be provided.
8. The daily tape for each sterilizer will be maintained and stored.
A complete review of the policy failed to show compliance with current standards of practice and regulations related to IUSS of surgical instruments. IUSS should be reserved for immediate use needs (e.g., used only emergently), when a needed instrument has been contaminated and there is no sterile replacement available, or for a patient care item that cannot be packaged, sterilized and stored before use). Additionally, IUSS of implants should only be performed when no other alternative is available and must have a biological indicator with every implant sterilized.

On 02/08/18 a review of the December 2017 Steris 1E instrument sterilization log, failed to show the presence of the bariatric scope used on Patient #5, which would indicate sterilization had occurred prior to use. Further review of the IUSS/Steris 1E logs for all of 2017 showed the following:
1. Monthly IUSS of surgical instruments in 2017 averaged between 60-70 loads each month or 779 loads annually.
2. Top 3 reasons IUSS was used:
- Doctor's Instruments
-Turnover of hospital instruments
- Loaner instruments - not sterile
3. Implants sterilized for immediate-use without biologicals confirming sterilization:
12/18/17 - Elbow Implant IUSS - no biological confirming sterilization.
03/01/17 - Implants spine lumbar thoracic - no biological confirming sterilization.
05/08/17 - Implant tray IUSS for orthopedic humorous ORIF - no biological confirming sterilization.
05/23/17 - Femur trial knee arthroplasty- no biological confirming sterilization.
07/11/17 - Implants ORIF maxilla- no biological confirming sterilization.
4. Multiple IUSS loads not indicating what was sterilized or why.
5. Orthopedics Surgery is the most prevalent instrumentation being IUSS.

On 02/07/18 a review of the facility Steris 1E sterilizer tapes for December 2017, showed there were five loads of instruments sterilized with the Steris 1E sterilizer, but no sterilizer tapes were found confirming sterilization parameters were met.

On 02/05/18 at 1:30 PM, the Surgical Services Manager confirmed the above findings related to IUSS of surgical instruments and sterilization tapes. She also stated the facility 2017 rate of IUSS of instrumentation was 6% of the 12,044 surgeries performed. The manager confirmed there were 779 loads of IUSS instruments used during patient surgeries in 2017.

On 02/07/18, a review of the facility 2017 hip and knee infections showed 10 infections. Two of the knee infections were noted to have had IUSS instruments used during their procedure. An interview conducted with the facility IP Manager confirmed these findings on 02/07/18 at 4:00 PM.

Review of the facility policy entitled, Disclosure of Unanticipated Outcomes & Event Resulting Serious Harm, #BC-RSK-105, revised on 12/06/16 and reviewed on 05/17 showed " the organization will communicate through disclosure to patients and/or their representatives when one of the following circumstances occurs:
1. An unanticipated outcome, which is not expected, and has not been disclosed to the patient prior to the treatment and /or procedure. Examples may include an event that does not cause serious patient harm but results in the need for treatment, intervention, or hospitalization (initial or prolonged).
2. An event that results in serious patient harm. Disclosure should not be postponed until all facts are known. Patients may be advised that "this is what we know today" and that additional information will be forthcoming as it becomes available.
3. When to disclose includes, as soon as practical after an event has occurred or been identified. Team members should notify the administrator on duty (AOD) and AOD should notify the Risk Manager (RM). Documentation of Disclosure showed the individual who discloses to the patient will have the responsibility of documenting in the notes of the medical record a brief statement of the facts and that a disclosure was made to the patient.

According to the CDC website referenced to June 6, 2017, "PEP (post-exposure prophylaxis) means taking antiretroviral medicines (ART) after being potentially exposed to HIV to prevent becoming infected. PEP should be used only in emergency situations and must be started within 72 hours after a recent possible exposure to HIV." Because Patient #5 was not informed of the potential exposure to blood and body fluids until three weeks after the event, the patient was not offered antiretroviral medicines within the 72-hour window recommended by the CDC, thereby placing the patient at risk for transmission of communicable diseases.

Review of Patient #5's medical record on 02/05/18 at 10:50 AM, showed the patient was admitted to the facility on 12/26/17 for a surgical procedure. Review of the operative report dated 12/26/17, showed the patient had bariatric surgery, in which a bariatric scope was used during the procedure. There was no documentation in the operative report of an incident related to the bariatric scope. Further review of the medical record failed to reveal documentation related to the use of an unsterilized bariatric scope. The physician discharge summary showed the patient was discharged on 12/28/17 with an uneventful post-operative course. The medical record failed to reveal blood borne pathogen (BBP) testing and disclosure of the event had occurred while the patient was still in the facility. Additionally, the facility was unable to produce evidence the scope used on Patient #5 had been sterilized or that sterilization parameters had been met on the Steris 1E tape printout.

An interview with the facility Infection Prevention (IP) Manager revealed she was made aware of the scope incident late in the afternoon of 12/28/17 by the OR assistant manager. The IP confirmed she was not verbally made aware of the incident on the date of the event, as required by policy. On 12/28/17, after confirming the details of the incident and how the sterilizer failed, the IP phoned the facility Infectious Disease Physician Chair, and was instructed to obtain BBP testing on the source patient (the patient that had the scope used immediately prior to the exposed patient), as well as the exposed patient. Before calling the surgeon, the IP checked to see if the patients were still in the facility, but both had been discharged. On 12/28/17, the IP manager phoned the surgeon that performed the surgery on both patients to advise him that they needed HIV and Hepatitis blood tests as soon as possible, due to the potential for exposure to BBP. The surgeon stated he would do that. On 01/10/18, the facility IP manager realized they had not received the results of BBP testing on these patients, so she had the surgical services IP once again contact the surgeon's office for the results of the BBP. The IP spoke with the surgeon's medical assistant (MA). The MA was not aware of the situation. The IP then went to the surgeon's office and provided requisition forms for BBP so both of the patients could be tested. The IP reiterated that both patients needed to be notified and tested as soon as possible. The IP manager stated she learned the surgeon made the exposed patient aware of the incident on her follow up visit with the surgeon on 01/17/18, 3 weeks after the exposure. The IP manager confirmed she had not called the patients to make them aware of the unsterile scope and the need for BBP testing. The IP manager stated that the facility had a BBP exposure policy for staff exposed to BBP's, but not for patients exposed to BBP. The IP confirmed post exposure prophylaxis (PEP) for HIV and hepatitis was not offered to the patient exposed to the unsterilized scope. The IP confirmed that PEP for HIV should be started within 72 hours of the exposure to BBP's.

On 02/07/18 at 10:10 AM an interview with the Quality Manger (QM) revealed the event report was not put into the computer incident reporting system until 12/28/17. The QM stated the surgeon had been notified at the time of the event in the OR on 12/26/17. The QM confirmed the medical record did not include documentation the patient was ever informed of the event.

On 02/07/18 at 11:40 AM, an interview with the Director of surgical services revealed she was aware of the incident, and still did not know who took the scope out of the sterilizer without checking the parameters. The Director confirmed the above findings related to Patient #5's exposure to an unsterilized bariatric scope used during surgery on 12/2/6/17.