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Based on observation, interview and document review the critical access hospital (CAH) was found to be out of compliance with Life Safety Code (LSC) requirements. These findings have the potential to affect all patients in the CAH.

Findings include:

Please refer to Live Safety code inspection tags at: K0051, K0076 & K0147.

Based on observation, interview and document review the critical access hospital failed to ensure staff properly cleaned and disinfected blood glucose monitoring equipment following patient use, in accordance with manufacturer recommendations for 1 of 1 patient (P2) observed to receive blood glucose testing with a multi-patient use device.

Findings include:

P2 was observed on 9/13/16, at 11:45 a.m. to have glucose monitoring conducted with use of a glucometer by nursing assistant (NA)-A. NA-A was observed to obtain a glucometer device from the docking station located at the nursing station and to remove a testing strip from a bottle located at the nursing station. At the time of the observation, NA-A stated she wasn't able to take the entire glucometer strip bottle into P2's room due to the patient having contact isolation precautions. NA-A was observed to utilize hand sanitizer upon entery to P2's room, she then placed the glucometer directly onto the counter located beside the hand sink. NA-A donned an isolation gown and gloves, checked P2's blood glucose, obtained an Oxivir Tb Wipe from a container, wiped over the surface of the glucometer, tossed the used wipe into the trash container and again set the glucometer directly onto the counter. NA-A then removed the isolation gown and gloves, used hand sanitizer, picked up the glucometer and returned the glucometer device to the nursing station where the glucometer was placed onto a docking station for future use. NA-A stated the glucometer was ready to be utilized on the next patient once P2's blood sugar value had been electronically transferred into the computer system.

Registered nurses (RN)-B and C were interviewed on 9/13/16, at 11:55 a.m. and verified the manufacturer instructions for the Oxivir Tb wipes indicated staff should: "allow surface to remain wet for 1 minute" for adequate disinfection. In addition, the nurses confirmed staff were expected to utilize a barrier between the machine and any patient care surface, including the counter by the hand sink.

During interview with RN-D (the infection control preventionist/officer) on 9/15/16 at 9:30 a.m., RN-D confirmed all staff received training on infection control practices and were educated to follow manufacturer recommendations for cleansing and disinfecting reusable equipment.

The manufacturer guidance for the Oxivir TB Wipes was reviewed. The guidance indicated a 60 second contact time was required in order to kill a wide variety of organisms associated with hospital acquired infections (HAIs) including: Norovirus, Hepatitis B, Hepatitis C, MRSA, VRE, Acinetobacter and Klebsiella in 60 seconds.

Review of the facility's policy Standard Precautions, with a revision date of 11/5/15, indicated: Surface and Reusable Equipment cleaning and disinfection: All assigned personnel are trained in the appropriate cleaning/disinfection procedures; the proper use of personal protection equipment (PPE), and proper use and contact time of cleaning/disinfectant products. Soiled patient care equipment will be handled in a manner that prevents cross-contamination of clean/sterile supplies and minimizes the potential for injury or exposure to others.

Based on observation, interview and document review, the Critical Access Hospital (CAH) was found not to be in compliance with the Condition of Participation of Surgical Services CFR 485.639. The CAH failed to ensure the safe use of electrocautery devices resulting in a risk for fire in the operating room and/or risk for patient burns for 1 of 1 patients (P1) observed during surgical procedures where the surgeon and/or surgical staff failed to operate the electrocautery device as directed by hospital policy and manufacturer recommendation. The cumulative effect of this systemic problem resulted in the CAH's inability to ensure the provision of quality health care in a safe environment.


Findings include:

P1 was observed on 9/14/16 at 11:00 a.m. during a surgical excision of a posterior neck mass. P1 was observed to utilize oxygen per face mask during the surgical procedure. During the procedure, it was noted the use of ForceTriad Energy Platform an electrosurgical (cautery) device was utilized by medical doctor (MD)-A and was placed on top of the drape near near the patient's neck and close to the oxygen mask. MD-A failed to place the electrocautery device into the holster several times during the procedure as follows:

1) At 11:10 a.m. MD-A was observed to utilize the cautery pencil and place it on top of P1's draped right shoulder area near the neck. After 1 minute, the certified surgical technician (CST)-A removed the cautery device from the drape and placed it into the holster.
2) At 11:15 a.m. MD-A was observed to place the cautery device on top of P1's draped right shoulder rather than in the holster provided. The cautery device remained on the drape for approximately 1 minute before CST-A removed the cautery from the patient's drape and placed it back into the holster.
3) At 11:20 a.m. MD-A was observed to place the cautery device on top of P1's drape near the neck instead of the holster provided. CST-A removed the cautery from the patient's drape and placed it back in the holster after 1 minute.
4) At 11:28 a.m. MD-A was observed to place the cautery device on top of P1's upper right shoulder on the surgical drape. CST-A removed the cautery from the patient's drape and placed it back in the holster after 30 seconds.
5) At 11:30 a.m. MD-A was observed to place the cautery device near P1's neck instead of in the holster provided. CST-A removed the cautery from the patient's drape and placed it back in the holster after 1 minute.

During interview with CST-A on 9/15/16 at 10:30 a.m., CST-A confirmed MD-A had failed to holster the cautery device as required. CST-A confirmed MD-A had placed the cautery pencil/device onto P1's drape twice during the surgical procedure. CST-A further included that when she had noticed the device had been placed on the drape, she would remove it and place it in the holster as soon as her hands were free to do so. CST-A further indicated she was aware that the cautery was close to the patient's oxygen and realized the potential severity of placing the cautery in the holster and should have prompted the surgeon to do so.

A review of the hospital's incident/accident reports for the past year revealed no incidents of fire/injury had occurred related to the use of electro cautery devices.

When interviewed on 9/15/16, at 11:00 a.m. the director of surgical services indicated all surgical staff have been trained regarding safe use of the electro cautery pencil and all staff were expected to place the cautery in the holster rather than on the drape.

Review of the facility's policy, Electrosurgical Safety dated 6/2016, revealed proper care and handling of electrosurgical equipment is essential to patient and personnel safety. The policy indicated the electrocautery should be used in a manner that minimizes the potential for injuries.

Review of the undated manufacturer's guidance for use of the ForceTriad Energy Platform cautery pencil, with the subject title Warning "Fire/Explosion Hazard", directed staff: "Do not place active instrument near or in contact with flammable materials such as gauze or surgical drapes. Electrosurgical instruments that are activated or hot from use can cause fire. When not in use, place the cautery pencil in a holster and safely away from flammable materials and patients."