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Based on interviews and document review, the facility failed to ensure surgical services were provided to acceptable standards of practice. Specifically, the facility failed to ensure a smoke evacuation device was used in the operating room during procedures that produced surgical smoke.

Findings include:

Facility policy:

The Surgical Smoke Evacuation Policy read, the reduction of surgical smoke inhalation is implemented using smoke evacuation equipment. To eliminate the hazards associated with surgical smoke inhalation, a surgical smoke evacuation system will be used with a disposable Electrosurgical Unit (ESU) pencil (a heat generating device that produces surgical smoke). Wearing a surgical mask is not adequate to prevent the inhalation of surgical smoke. A smoke evacuation system is activated at all times when surgical smoke is produced during the procedure. Effective surgical smoke evacuation needs to occur as close to the surgical site as possible in order to capture the surgical smoke. Regular wall suction used to suction fluid is not an appropriate or acceptable surgical smoke evacuation method.

References:

According to House Bill 18-1399,
https://leg.colorado.gov/sites/default/files/documents/2018A/bills/2018a_1399_01.pdf:
25-3-118. Regulation of surgical smoke - requirement to adopt 5 a policy - rules - definitions - applicability. (1) ON OR BEFORE JULY 1, 6 2019, A HOSPITAL WITH SURGICAL SERVICES OR AN AMBULATORY 7 SURGICAL CENTER, LICENSED IN ACCORDANCE WITH THIS ARTICLE 3, 8 SHALL ADOPT A POLICY TO PREVENT HUMAN EXPOSURE TO SURGICAL 9 SMOKE.THE POLICY MUST INCLUDE THE REQUIREMENT TO USE A SURGICAL 10 SMOKE EVACUATION SYSTEM WHENEVER A PROCEDURE GENERATES 11 SURGICAL SMOKE.

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017:

Recommendation I.b.2 (page 483) Smoke evacuation should be used in addition to room ventilation.

Recommendation II.a (page 485) The perioperative team should use a smoke evacuation system (e.g., smoke evacuator, in-line filter) to evacuate all surgical smoke.

Recommendation II.a.2 (page 492) A smoke evacuator with a 0.1 um filter (e.g., ultra-low particulate air [ULPA]) should be used when surgical smoke is anticipated.

According to the The Association of periOperative Registered Nurses (AORN) Facility Reference Center, 2012-2022,
https://aomguidelines.org/guidelines/content?sectionid=173725179&view=book#173725179, AORN Guidelines for Perioperative Practice: Surgical Smoke Safety, surgical smoke evacuation and filtration systems, administrative policies and procedures, staff education and training are needed to reduce exposure to surgical smoke and establish safe surgical practices and directly reduce exposure to the hazards of surgical smoke.

1. The facility failed to ensure ESU units (a medical device used to cut and coagulate tissues) were used in accordance with a state house bill, facility policy, and nationally recognized guidelines. Specifically, the facility failed to ensure a smoke evacuation system (a filtration system to reduce exposure to surgical smoke) to evacuate and filter surgical smoke (a smoke byproduct composed of biological particles, cells, and toxic chemicals) was implemented during surgical procedures.

a. Medical records for Patient #1, Patient #2, and Patient #5 were reviewed and revealed the following:

i. Record review revealed Patient #2 had a right L4-L5 Microdiscectomy and a right L5-S1 Microdiscectomy (a surgical procedure to relieve pressure on the spinal nerve due to a herniated disc) performed.

ii. Record review revealed on 6/15/22 Patient #5 had a Left L5-S1 Discectomy (a surgical procedure to remove a herniated or degenerative disc in the lower spine) performed.

iii. Record review revealed on 7/5/22 Patient #1 had a Left L2-3 Discectomy (a surgical procedure to remove a herniated or degenerative disc in the lumbar spine) performed.

According to the Panel 1 Combined Pick Lists (list of all surgical instruments and supplies used for each procedure) for Patient #1, Patient #2, and Patient #5, there was no evidence an ESU with a smoke evacuator was used to filter surgical smoke during the procedure.

This was in contrast to the Surgical Smoke Evacuation policy, which stated, the hazardous surgical smoke produced when using ESUs will be eliminated through the use of a surgical smoke evacuation system. Surgical smoke evacuation systems must be used to eliminate surgical smoke. The use of a fluid suction device may not be used to evacuate surgical smoke.

b. Interviews

i. An interview on 7/5/22 at 5:05 p.m. with registered nurse (RN) #1 was conducted. RN #1 stated Surgeon #1 did not use a smoke evacuator bovie (an ESU, or a medical device used to cut and clot tissues during a surgical procedure). RN #1 also stated AORN guidelines were the standard for practice requiring the use of a smoke evacuator bovie.

ii. An interview on 7/6/22 at 9:22 a.m. with RN #2 was conducted. RN #2 stated he was present during Patient #1's surgical procedure on 7/5/22. RN #2 stated Surgeon #1 used an ESU during the procedure but did not use a smoke evacuation device. RN #2 stated surgical smoke contained carcinogens (a substance known to cause cancer) and harmful particulates. Furthermore, RN #2 stated inhalation of surgical smoke was known to cause adverse health effects.

iii. An interview on 7/6/22 at 12:35 p.m. with Surgeon #1 was conducted. Surgeon #1 stated he had not been using the ESU with a smoke evacuator, although he previously had tried this device. Surgeon #1 stated the ESU with the attached smoke evacuator was bulky and difficult to use. He then stated he ultimately "abandoned" the use of an ESU with the attached smoke evacuator. Surgeon #1 stated he recognized the facility wanted a smokeless environment, however, he continued to use ESU devices without the smoke evacuator.