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Based on records reviewed and interviews, for one of four contracts, the Hospital failed to take actions through the Hospital's QAPI program to: assess those services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities and ensure the monitoring and sustainability of those corrective or improvement activities.

Findings include:

The Surveyor observed in the Pre-Operative Unit on 11/7/18 at 8:05 A.M., the Neurophysiological Monitoring Technologist explain to Patient #6 the neurological testing she would perform in the Operating Room.

The Surveyor observed in Operating Room #9 that the Neurophysiological Monitoring Technologist had inserted needles into Patient #6's lower extremities connected to monitoring cables to monitor Patient #6's nerve conduction during the lumbar (low back) surgery. This neurological monitoring assessed the spinal system to reduce the risk of spinal cord injury.

Review of the of the contracted services provided by the Hospital indicated that the Hospital had contracted with Intraoperative Neurophysiological Monitoring Services on 10/9/18 which provided preoperative, intraoperative and postoperative neurophysiologic monitoring services and clinical neurophysiological testing services conducted by qualified Neurophysiological Monitoring Technologists. The Monitoring Technologist was trained in intra-operative neurophysiological testing and monitoring surgical procedures.

According to the contracted service agreement, the Hospital will accommodate professional supervision by the monitoring company's affiliated staff as part of compliance, risk management and patient safety.

The Surveyor interviewed the Manager of Quality Regulatory and Infection Prevention on 11/8/18 at 8:04 A.M. The Manager of Quality Regulatory and Infection Prevention said the Hospital QAPI process had not evaluated the contracted Neurological Monitoring Service.

The Hospital was out of compliance with the Condition of Participation for Infection Control.
Findings include:

The Hospital failed to implement, for five of five patients with Surgical Site Infections, an organized, data driven, scientific infection investigation that considered the causative organism (Staph aureus), its mode of transmission and known reservoir.

Based on records reviewed and interviews the Hospital failed, for five (Patient #1, Patient #2, Patient #3, Patient #4 and Patient #5) of ten sampled patients, to ensure that the Hospital implemented timely interventions based on the identified pathogen's mode of transmission and known reservoir when there was an identified cluster of five Surgical Site Infections; failed to ensure the manufacturer's directions for use was followed for high level disinfection and that adequate documentation of sterilization logs was maintained; and, failed to ensure that an expired solution was replaced and that employee health policies were followed related to N95 fit testing.

Findings include:

1.) On 11/6/18 the Surveyor requested a copy of the Hospital's Outbreak Investigation Policy. Infection Preventionist #1 said the Hospital did not have a formal policy.

The Surveyor reviewed the Association for Professionals in Infection Control and Epidemiology (APIC) Consultant Corner related to an Outbreak Investigation. The publication indicated the primary elements of an effective outbreak investigation included:

a. Confirm the diagnosis and determine that an outbreak exists.
b. Identify additional cases and create a line list.
c. Generate a hypothesis (a proposed explanation used as a starting point for further investigation) regarding outbreak sources and modes of transmission.
d. Implement control measures, communicate findings to the outbreak team, and continue surveillance.

The Surveyor reviewed the Line Listings associated with post-operative spine surgeries with identified infections on 11/6/18. The Line Listing indicated that the Hospital had identified five cases of Surgical Site Infections with the causative agent of Staph aureus.

According to the Center for Disease Control and Prevention, humans are a natural reservoir and Staph aureus is usually spread through direct contact with another person, not through the air.

The Surveyor interviewed the Chief of Surgery at 3:15 P.M. on 11/6/18. The Chief of Surgery said that the stakeholders had been meeting as an "Action Group" to design the investigation. The Chief of Surgery said that the Infectious Disease Physician had not attended these meetings but was easily accessible to the group. The Chief of Surgery said these were not formal meetings but the members had done a drill down to identify the commonalities of these cases i.e. suture material, gloves, drains, skin prep and surgical hand care used by the provider. The Chief of Surgery said that the Action Group had directed the environmental culturing.

The Surveyor reviewed the document titled 2018 SSI Investigation Report. According to the Report, between 10/17/18 and 11/2/18, a total of 43 environmental sites had been cultured. The Report consisted of surgical instruments, OR Imaging Equipment, Sterile Dressings and implantable screws. None of the 43 sites cultured yielded any evidence of Staph Aureus.

The Surveyor reviewed the minutes of the Infection Control Committee dated 10/24/18. Despite being aware of four Surgical Site Infections related to spine surgery in the weeks prior to the Infection Control Committee, there was no presentation to the Committee of the cluster of infections. The Infection Control Committee minutes read that there were additional Surgical Site Infections that the program was struggling with and that a separate work group was involved.

The Surveyor reviewed the posters and the minutes from the Surgical Site Infection Work Group. The minutes indicated the areas of discussion were the financial impact of Surgical Site Infections, the recent flux of Surgical Site Infections, antimicrobial stewardship, Operating Room prep and the importance of culturing common equipment, surfaces and instruments used in surgery. The minutes indicated additional information about pre-procedure nares screening and CHG (chlorhexidine gluconate) bathing. The minutes indicated the resulting action plan would be physician individual practice, Operating Room staff practice (i.e. changing gloves and surgical attire) screening for surgical patients and the environmental items to be cultured.

The Surveyor interviewed the Director of Surgical Services at 10:00 A.M. on 11/6/18. The Director of Surgical Services said the decision about pre-procedure skin care for the patient had been approved the day before survey began.

The Surveyor toured the Central Sterile Processing Department at 11:22 A.M. on 11/6/18. The Manager of the Central Sterile Processing Department said that Neurological Surgeon #1's surgical instruments had been sequestered because it was thought the instruments may have been a potential source of surgical site infections; however, cultures of these instruments did not indicate there was a pathogenic organism.

The Surveyor reviewed the Service Agreement for Infectious Diseases Services. The Agreement indicated that the Infectious Disease Physician would serve as Chair of the Hospital's Infection Control Committee, support the existing antimicrobial stewardship program, attend regular meetings with the Infection Control Practitioners and the Chief Medical Officer and would be available for questions from the Microbiology Laboratory and provide information in the event of a public health emergency. The Agreement indicated an allotment of two hours per week.

The Surveyor interviewed the Infectious Disease Physician at 1:30 P.M. on 11/7/18. The Infectious Disease Physician said she was contracted two hours per week however she did not watch the clock. The Infectious Disease Physician assured the Surveyor that she was able to fulfill her duties within that amount of time. The Infectious Disease Physician said she had not attended the Surgical Work Group or the Action Group but was in phone contact with Infection Preventionist #1. The Infectious Disease Physician said she was concerned about the cluster of Surgical Site Infections that had been identified. The Infectious Disease Physician said, while she was well aware of Staph Aureus being a skin bug, the environmental cultures were underway under the direction of the Chief of Surgery. The Infectious Disease Physician said she would be most concerned about hand hygiene, surgical scrub and skin antisepsis. The Infectious Disease Physician said she was aware that she had not attended the Infection Control Committee since March of 2018. The Infectious Disease Physician said because the sensitivity testing (a test that determines the "sensitivity" of bacteria to an antibiotic) from the microbiology testing of the Staph aureus was different that she did suspect a single source was the cause of the cluster of infections. The Infectious Disease Physician said she was not aware that the isolates (a microbiology sample that is held for further specialty testing) from Patients #1, 2, 3, or 4 had not been saved as part of the infection investigation. The Infectious Disease Physician said she was not aware that Neurosurgeon #1's instruments had been sequestered and she had not yet spoken with Neurosurgeon #1.

The Hospital Policy titled Sterile Technique, dated 6/25/18, indicated to establish and maintain sterile technique, implementing sterile technique, when preparing, performing, or assisting with surgical and invasive procedures is the cornerstone of maintaining sterility and preventing microbial contamination. In addition, prevention of healthcare associated infections is a priority of all healthcare providers. Healthcare associated infections can result in untoward outcomes such as increased morbidity and mortality, longer length of stay, pain and suffering. Team members should observe for, recognize and immediately correct breaks in sterile technique when preparing, performing, or assisting with surgical or invasive procedures.

The Surveyor interviewed Registered Nurse (RN) Circulator #1 at 8:37 A.M. on 11/7/18 and at 12:52 P.M. on 11/8/18. RN Circulator #1 said that the five surgical site infections were only for patients who had a lumbar (low back) surgical approach (the location of the surgical incision). RN Circulator #1 said Neurosurgeon #1's usual practice for marking (to determine the exact location of the surgical incision) was to insert two sterile spinal localizing needles approximately three quarters of an inch into the patient's lower mid back to determine the area for making the surgical incision. RN Circulator #1 said Neurosurgeon #1's did not disinfect the patient's skin before inserting the needles. In addition, if Neurosurgeon #1's needle placement was incorrect he would re-insert (reuse) the same used needle (instead of obtaining a new sterile needle) into the patient's back.

The Surveyor interviewed Neurosurgeon #1 at 9:10 A.M. on 11/7/18. Neurosurgeon #1 said the surgical site infections for Patients #1, #2, #3, #4 and #5 all had the same posterior back approach for their surgeries and the surgical instruments were the probable cause of these infections. Neurosurgeon #1 said he now uses different surgical instruments.

The Surveyor interviewed the Chief Medical Officer at 11:00 A.M. on 11/8/18. The Chief Medical Officer said that when Infection Preventionist #2 monitored Patient #4's surgery performed by Neurosurgeon #1 on 10/18/18, Infection Preventionist #2 thought she may have observed a breech in infection control practice related to not disinfecting Patient #4's skin. The Chief Medical Officer said that Neurological Surgeon #1 should have disinfected the patient's skin prior to inserting localizing needles into the patient's back.

The Surveyor interviewed Infection Preventionist #1 at 9:30 A.M. on 11/8/18. Infection Preventionist #1 said that the details of the investigation had not been widely discussed so as not to cause embarrassment to those involved. Infection Preventionist #1 said that there were no monitors (i.e. hand hygiene or surgical skin preps) or education with OR staff related to Staph aureus including the known reservoir or modes of transmission.

The Surveyor interviewed Infection Preventionist #2 at 9:45 A.M. on 11/8/18. Infection Preventionist #2 said that she had observed one of Neurosurgeon #1's spine surgeries. Infection Preventionist #2 said she had some questions for the surgical team but made no formal recommendation. Infection Preventionist #2 said the patient that she observed (Patient #4) was later admitted to the Hospital with a Surgical Site Infection.

2.) The Surveyor toured the Operating Room at 10:00 A.M. on 11/6/18 and interviewed the Director of Perioperative Services. The Director of Perioperative Services said that the Steris 1E was used to sterilize some of the Urology scopes and provided the Steris 1E log to the Surveyor. The Steris 1E log indicated that the date, the patient identification and the serial number was required in order to track that the equipment had been reprocessed. Of the seven entries into the Steris 1E log only five patient stickers had been used. The Steris 1E log then used a color code to determine the serial number of the scope. One of the seven entries into the Steris 1E log did not indicate the color and it would not be possible to determine which scope had been used with the patient.

The Surveyor interviewed the Manager of the Central Supply Reprocessing Area at 11:20 A.M. on 11/6/18. The Manager of the Central Supply Reprocessing Area provided the Surveyor with the print out from the Steris 1E sterilizer. The print out did not include any identifiers (i.e. patient sticker or the scope serial number) so validation that the Steris 1E had been used to sterilize and meet all of the parameters for sterilization could not be made.

3.) The Surveyor toured the reprocessing room in the Endoscopy Suite at 1:25 P.M. on 11/6/18 and interviewed Endoscopy Tech #2. Endoscopy Tech #2 said that she tested the High level Disinfectant reservoir using a dipstick daily. According to the manufacturer's directions for use, testing of the reservoir must be done prior to each reprocessing cycle.

4.) The Surveyor toured the pre-surgical area at 9:50 A.M. on 11/6/18. The eye wash station fluid expired in August of 2018. The Director of Surgical Services arranged for an immediate replacement.

5.) The Surveyor interviewed Endoscopy Tech #1 at 1:30 P.M. on 11/6/18. Endoscopy Tech #1 said that he would be able to assist in a Bronchoscopy procedure and don an N95 (special particulate respirator mask) if needed because he was fit tested annually to the mask. The Surveyor reviewed Endoscopy Tech #1's employee health record and he had not been fit tested since 10/31/14.