HospitalInspections.org

Based on interview and record review the facility failed to ensure that tuberculosis prevention precautions were implemented for one (#15) of two patients reviewed for tuberculosis infection resulting in the potential for transmission of infection to staff providing care and patients in close contact. Findings include:

On 5/13/19 at approximately 1445 during a tour of the radiology department with Staff DD, the Radiology Manager, Staff HHH reported that staff had a Tuberculosis (TB) exposure (exposed to a patient infected with active TB) over the weekend.

On 5/13/19 at approximately 1450 Staff DD was interviewed said she was called by the Radiology Department Supervisor who informed her that Radiology staff had an exposure to TB on 5/11/19 during a chest CT scan on 5/11/19 of a Patient with active TB (Patient #15). Staff DD said at this time that she received notification of this over the weekend, and the facility was compiling a list of staff who provided care to this patient so that a TB exposure follow up could be done for them. Staff DD reported that a facility incident report (RL solutions) was completed for this event.

On 5/14/19 at 1330 the facility Infection control (IC) program was reviewed with Staff DD, and the facility IC team, Staff TT, Staff UU, Staff VV, Staff WW and Staff XX. Review of the IC program 2019 risk assessment revealed the facility was assessed as at moderate risk for TB infections. Review of 2018 IC data revealed three patients with TB were diagnosed in the facility and eight staff conversions (staff who were negative for TB infection became positive for TB infection) occurred in 2018. Review of 2019 IC data revealed that four TB cases were diagnosed to date in 2019 with no staff conversions noted.

On 5/14/19 at approximately 1340, Staff DD and Staff XX revealed the patient infected with TB who was seen in the facility over the weekend and potentially exposed staff to TB was Patient #15.

On 5/14/19 at approximately 1345 Patient #15's clinical record was reviewed with Staff DD and Staff XX and revealed the following:

Patient #15 was a 45 year old male who was referred to the facility for a CT scan of the chest by the local public health department. The prescription form for the procedures from the local public health department noted that Patient #15's diagnosis for the procedure was " Positive (+) QFT (Quantiferon alpha release assay (QFT-G) test- a blood test for active or latent TB). Patient #15 received testing in the facility Radiology department on 5/11/19 and there was no documentation to indicate that he wore a protective mask while in the facility or that his TB infection was noted until after the radiologist reported the results of his test.

On 5/14/19 at approximately 1500 Staff DD and the entire Infection Control Department Team were interviewed regarding this, and an RL solution adverse event report for the incident was reviewed. Staff DD stated that post exposure follow-up protocol was initiated immediately. Staff DD stated that usually the health department notified the hospital before they sent a TB positive patient so that they could put the correct mask on the patient as soon as they entered the building. Staff DD and the IC staff all stated that the Radiology Department Patient Registration staff should have known that the patient had a communicable disease because the patient had a prescription for a chest CT scan by the public health department. Staff DD stated that this was missed because the non-clinical Patient Registration Staff did not realize that a diagnosis of +QFT meant that the patient had TB. The Infection control lead, Staff XX stated that it might be a good idea to make sure that all Patient Registration staff received training/education on screening for diagnoses or symptoms of TB. Staff XX reported that facility IC policies required all patients with symptoms of TB to wear an approved mask and be placed in droplet isolation precautions on arrival to the facility. A facility policy for TB precautions and prevention was requested but not provided.

Based on observation, interview and record review, the facility failed to ensure that hinged surgical instruments were processed and packaged in the open position according to their policy and acceptable standards of practice for 23 of 30 autoclaved pouches of hinged surgical instruments (peel packs) observed in the sterilized and ready to use inventory in one of two Central Sterile Processing departments of the facility and in addition, the facility failed to ensure that sterilized multi-layer surgical instrument containers contained a sufficient number of sterilization adequacy indicator strips according to their policy for one of one sterilized and ready for use wrapped surgical instrument containers inspected in one of two Central Sterile Processing departments of the facility, resulting in the potential for transmission of surgical site infections. findings include:

On 5/15/19 at approximately 0830 the central supply and sterilization (CSS) department at the facility's outpatient surgery center was toured with the facility Director of Nursing Operations Staff DD, the Administrative director of Surgical Services Staff GGG and the Supervisor of the out patient surgery site CSS Staff YY. 30 peel pouches (sterilized packages) of hinged surgical instruments in the ready for use storage racks were inspected. 23 peel pouches contained instruments that were autoclaved and packaged in the locked and closed position.

On 5/15/19 at approximately 0845 Staff YY and Staff GGG stated that hinged instruments could not be adequately sterilized if they were autoclaved in the locked position, as the surfaces that were locked closed could not be penetrated by the steam for sterilization. Staff GGG was asked if she could guarantee that these instruments were washed in the open position before they were placed in the peel pouches and autoclaved (sterilized in the steam sterilizer) in the closed position. Staff GGG replied that she could not guarantee that the instruments were adequately washed if they weren't opened. Staff GGG said that if the hinged instruments weren't opened when they were put into the peel pouches for sterilization she could not be sure that they were opened for washing.

On 5/15/19 at approximately 0850 Staff GGG inspected the build labels on each of the peel pouches and stated that these peel pouches of surgical instruments were processed within the past two weeks. Staff GGG stated that the peel pouch build labels indicated that 24 of these peel pouches were processed by the same staff member, a non certified central sterile processing technician. Staff AAA.

On 5/15/19 at approximately 0845 a wrapped, sterilized and ready for use container of surgical instruments (orthopedic set) was opened by Staff GGG and Staff YY for inspection. The set contained three layers (organizer trays) of instruments, one on top of the other inside the container. There was a spongy rubberlike matting on the bottom of the container underneath the bottom layer of instruments. The only sterilization indicator noted was on the inside of the top lid of the instrument container/case. There was no sterilization monitor/indicator on any of the middle organizing trays of the container or on the bottom of the container. Staff GGG removed all of the instruments in the container and was unable to fine any additional sterilization indicators in any of the three layers/organizing trays of instruments. Staff GGG said that there should be a sterilization indicator on the bottom corner of the container as well as the one on the top to ensure that the sterilization steam reached every layer in the tightly packed container. Staff GGG stated that the facility did not require an indicator to be placed on each level of multi level instrument containers. When asked, Staff GGG reported that the label on the container/case indicated that this container (set) of surgical instruments was assembled and processed by the same CSS technician who had processed the hinged surgical instruments in the closed/locked position.

On 5/15/19 at approximately 1040, eight CSS technician staff personnel files were reviewed for staff training, certification and competency evaluations. Three CSS staff reviewed did not have certification in Sterile Processing of Surgical instruments. Staff GGG stated that CSS employees who were hired prior to the requirement that all CSS staff be sterilized within 18 months of hire were "grandfathered in" and did not need certification.

On 5/15/19 at approximately 1040 Staff AAA's annual competency evaluation dated 7/2/18 was reviewed and revealed that two of 22 competency observations (performance indicators #9 and #10) were marked as observed but were not checked (approved) as "performed" (met). One of the performance measures that was not documented as competently performed was, "Packages items to insure sterilization (opens/takes apart instruments before placing items in packages for the autoclave)".

On 5/15/19 at approximately 1100 the CSS Manager Staff EE was interviewed and asked about Staff AAA's competency evaluation on 7/2/18. Staff EE stated that he did not remember. Staff EE stated that maybe he was called away to do something while he was doing the evaluation and did not finish the observations of items #9 and #10 in the evaluation and that is why he didn't document that Staff AAA performed these competently. Staff AAA stated that he went to the out patient surgery site CSS several times a week and frequently observed Staff AAA at work and felt that Staff AAA always met expectations for competency and proficiency in decontamination and sterilization of surgical instruments. When asked about the observed concerns, Staff EE stated, "Maybe (Staff AAA) was having an off day."

On 5/15/19 at 1615 review of the provided facility policy entitled, "INF - Sterilization and Disinfection", (no date indicated) revealed the following statements,

"All instruments are to be opened and disassembled prior to sending through the washer/decontaminator."

"All instruments are to be opened and disassembled prior to sterilization."

"An internal indicator should also be placed in the corner of single level trays and on each level of multi-level trays."