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Based on observation, document review, and staff interview, the facility failed to develop an active Infection Prevention Program that provided appropriate monitoring to ensure all surgical instruments were sterile and that an effective system was in place to identify, track, and monitor surgical site infections. The facility failed to:

1. ensure Sterile Processing Technicians performed Biological Indicator monitoring according to the manufacturer's directions. (Refer to A-749)

2. ensure the Infection Control Nurse developed and implemented an effective system to detect, track, and monitor surgical site infections. (Refer to A-749)

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to guarantee sterility of the surgical instruments and determine if surgical site infections had increased as a result.

I. Based on observation, document review, and interviews, the facility failed to ensure Central Sterile Staff followed the manufacturer's directions when using biological indicators in 2 of 2 terminal sterilization autoclaves when staff did not use a 16-towel pack. The facility identified an average of 180 surgical procedures performed at the facility per month that required sterile surgical instruments.

Failure to follow the manufacturer's directions for challenging the biological indicators resulted in the facility's inability to ensure the items processed in the terminal sterilizer autoclaves had received sufficient conditions to kill all microorganisms on the surgical tools. Failure to kill all microorganisms could potentially result in microorganisms remaining on the surgical tool used with one patient to potentially cause an infection in another patient.

Findings include:

1. Observations, during a tour of the surgical services department, on 3/19/13 at 1:40 PM, revealed the facility had 2 terminal sterilization Autoclaves (devices that used steam pressure, heat, and time to kill all the bacteria, viruses, and fungi on surgical tools) in the Central Sterile Processing department. Further observations revealed 1 partially empty box of individual 3M Attest 1292 Biological Indicators (BI, a tube approximately 1-inch by 1/8th-inch in diameter that contained bacterial spores from the most difficult to kill bacteria. If the autoclave killed the spores, the facility could verify the autoclave would actually kill all other bacteria, viruses, and fungi).

During an interview, at the time of the tour, Sterile Processing Technician (SPT) A stated she placed the individual 3M Attest 1292 BI into a small metal box, and placed the box in the autoclaves every morning in the coldest part of the autoclave.

Observation of the metal box revealed a stainless steel box approximately 6-inches long, 4-inches wide, and approximately 1/2-inch thick. The box had 2 hinged flaps on the top surface to allow placement of objects inside the box. The box contained numerous small holes in all metal sides to allow steam to penetrate the box in the autoclave, but keep the contents from falling out.

SPT A demonstrated the method she used to prepare the BI test by opening one of the hinged flaps, placed an individual 3M Attest 1292 BI into the box, and closed the flaps on the box. SPT A stated she would place the unwrapped box in the coldest part of the autoclave.

During an interview on 3/20/13 at 9:10 AM, SPT A stated she ran the autoclave with a BI test pack at 270 degrees Fahrenheit for 4 minutes using a vacuum assist. She placed surgical instruments in a wrapped package inside the autoclave, and ran the autoclave cycle using the same parameters.

SPT A stated she had placed a biological indicator in the autoclave following the procedure she described on 3/19/13 at 1:40 PM. SPT A relied on the biological indicator to show the autoclave had killed all the mirco-organisms on the surgical tools and the surgical instruments were sterile. SPT A stated she also placed a BI into all autoclave loads that contained an implant such as a screw or plate used to repair a broken bone.

2. According to the Infection Control Nurse, the facility subscribes to the practices recommended by the Association of Professionals in Infection Control and Epidemiology (APIC). Review of the APIC text, Chapter 21, copyright 2013, revealed in part, "Critical Items involve a high risk of infection if such an item is contaminated with any microorganisms, including bacterial spores. Thus, it is critical that objects that enter sterile tissue or the vascular system be sterile because any microbial contamination could result in disease transmission. This category of items includes surgical instruments...implants ...used in sterile body cavities. The items in this category should be...sterilized with steam sterilization if possible."

3. Review of the manufacturer's directions for the 3M Attest 1292 Biological Indicators, copyright 2005, revealed if the facility used an autoclave cycle at 270 degrees Fahrenheit for 4 minutes with vacuum assist with wrapped instruments, the facility was required to place the Biological Indicator inside an AAMI 16 towel pack (a stack of 16 folded surgical towels, with the BI placed in the middle of the stack).

4. During a phone interview on 3/20/13 at 9:40 AM, 3M Help Line Customer Service Representative (CSR) B stated the facility's practice of placing the 3M Attest 1292 BI into an unwrapped metal box and placing the box in the coolest place in the autoclave did not meet the manufacturer's requirements for the BI to fully measure if the autoclave could kill all the microorganisms (bacteria, viruses, and fungi). According to the 3M Help Line CSR B, the facility would need to place the BI in a package, such as a 16-towel pack, to increase the difficulty of the steam penetrating to the BI, and increased the chances of the steam to not fully kill all the bacteria in the BI.

5. During an interview 3/19/13 at 4:00 PM, the Director of Surgical Services stated if SPT A failed to follow the manufacturer's recommendations for the 3M Attest 1292 BI, the biological indicator could give the facility a false negative (when the biological indicator incorrectly shows the autoclave killed all the microorganisms in the packages when, in fact, the autoclave had actually allowed some microorganisms to live, providing an opportunity for transmission to another patient). SPT A stated she had not read the 3M 1292 Attest BI manufacturer's instructions for use. She stated if she had read the manufacturer's instructions, she would have performed the BI monitoring as 3M required.

6. During an interview on 3/21/13 at 11:20 AM, the Director of Patient Care Services stated the facility did not know when the sterile processing department started to use the 3M Attest 1292 Biological Indicators incorrectly. She acknowledged SPT A had failed to follow the manufacturer's instructions for the 3M Attest 1292 BI. Since the facility did not know when the sterile processing department had started to use the 3M Attest 1292 BI incorrectly, and SPT A had failed to follow the manufacturer's instructions, the facility could not verify the sterility all of the surgical instruments in the facility, including the instruments currently in use in the operating rooms.


II. Based on document review and staff interview, the facility failed to develop and implement an effective system to detect, track, and monitor surgical site infections. The facility identified an average of 180 surgical procedures performed at the facility per month.

Failure to have an effective system to detect, track, and monitor surgical site infections
inhibits the facility's ability to identify and treat patients with surgically-related infections. This also inhibits the facility's ability to identify patterns and trends in surgically-related infection rates, which would enable the hospital to identify the source of the problem and change their practice to prevent or minimize future infections.

Findings include:

1. During an interview on 3/20/13 at 1:30 PM, the Infection Control Nurse stated she used data from wound cultures to determine if a patient developed a surgical site infection. Additionally, the Infection Control Nurse stated she followed the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN) definitions for surgical-site infections when she calculated the incidence of surgical site infections at the hospital. She stated she was responsible for determining the number of surgical-site infections that occurred at the hospital and research the causes.

2. Review of the CDC NHSN guidelines, dated 1/12, revealed the NHSN defined a surgical site infection as an infection that occurred within 30 days of the operation if the surgeon did not leave an implant (a device such as a screw or plate to fix a broken bone) in the patient. If the surgeon left an implant in the patient, the guidelines defined a surgical site infection as an infection relating to the implant that occurred within 1 year of the surgery.

3. During an interview on 3/21/13 at 10:00 AM, the Director of Surgical Services stated the facility had an implant log and produced the implant log for the prior year. She stated the Infection Control Nurse had access to the log as the Director of Surgical Services stored the log on a shelf in the Surgical Services department.

4. During an interview on 3/20/14 at 1:30 PM, the Infection Control Nurse stated she did not proactively monitor for surgical site infections at the facility. She had the Laboratory Manager send her all of the reports of all wounds cultured (a process to determine what bacteria caused an infection) through the facility. She examined every culture to see if the patient had received care at the facility and looked for possible causes of the infection. She also relied on surgeons to report any surgical site infections to her.

The Infection Control Nurse did not proactively solicit the surgeons to report surgical site infections to her. Instead, she relied on passive methods. Additionally, if a surgeon did not culture the wound, or immediately sent a patient to another hospital to treat the wound, she stated she would not know about the surgical site infection.

The Infection Control Nurse acknowledged she lacked a method to determine if a patient developed a surgical site infection within 30 days after the surgery. Additionally, she lacked a method to determine if a patient developed a surgical site infection related to an implant left in a patient after a surgical procedure within the prior year. According to the Infection Control Nurse, facility staff called patients within 1 or 2 weeks after delivering a baby to see how they were doing. She also said staff called patients who had undergone procedures and/or surgery but didn't know what the timeframe was for those calls. The Infection Control Nurse acknowledged it would be unlikely that patient's would have signs and symptoms of a surgical site infection recognizable by a patient within 24-48 hours.

The Infection Control Nurse stated she only knew of 3 surgical site infections during the past 15 months. She acknowledged she relied on the surgeons to notify the Infection Control Nurse in all 3 cases. The Infection Control Nurse could not guarantee a surgeon had not treated an unreported surgical site infection during the prior year. The Infection Control Nurse could only account for the surgical site infections where the surgeon had cultured the wound. The Infection Control Nurse could not account for any surgical site infections where the surgeon did not culture the wound, but diagnosed a surgical site infection.

During an interview on 3/21/13 at 1:50, the Director of Surgical Services reported staff call surgical patients the next working day after surgery.

During an interview on 3/21/13 at 2:00, the Director of Inpatient Services reported staff call surgical patients the day after their discharge but within the first 48 hours.

The Director of Surgical Services and the Director of Inpatient Services acknowledged it would be unlikely that patient's would have signs and symptoms of a surgical site infection recognizable by a patient within 24-48 hours.

The Infection Control Nurse, Director of Surgical Services, and the Director of Inpatient Services acknowledged the facility had a form staff used when calling post-surgical patients. However, the form staff used for these calls did not direct staff to ask questions related to the patient's surgical site that would include signs and symptoms of surgical site infection. They also reported staff did not ask questions specific to the patient's surgical site and/or signs and symptoms of infection during the phone calls.