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Based on documentation, observation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure Surgical Department temperature and humidity levels were maintained within the required ranges to promote a safe surgical environment for surgical patient care. This has the potential to affect all patients serviced by the CAH Surgical Department which performs an average of 56 surgical procedures monthly.

Findings include:

1. The CAH policy titled "O.R. Daily Work Checklist" was reviewed on 8/15/18 at approximately 11:10 AM. The policy stated "Procedure and rationale: 3. Prior to start of surgical cases temperature/humidity will be checked. Any temperature or humidity out of range (temperature 68-75 degrees (Fahrenheit), humidity 20-60%) supervisor and maintenance notified immediately. 4. If unable to control temperature or humidity within parameters the OR will be closed until parameters achieved."

2. The AORN (Association of periOperative Registered Nurses) 2015 Edition Guidelines for Perioperative Practice was reviewed on 8/15/18 at approximately 11:10 AM. On page 274, the guidelines stated, "Environment of Care, Part 2 Table 2: HVAC (Heating, Ventilation, Air Conditioning) Design Parameters 1, 2" The table stated the Operating room "Humidity 20% to 60%" and the "Temperature 68 F to 75 F". The table further stated T/H ranges for the "Preparation and packaging/clean workroom ... Clean/sterile storage ... Postanesthesia care unit ... Procedure room ... Gastrointestinal endoscopy procedure room ..."

3. An observational tour of the Surgical Department was conducted on 8/15/18, between approximately 9:30 AM and 10:20 AM, with the Director of Surgery and Obstetrics (E#3). The following were noted:
a. A dehumidifier was in the Women's Locker room bathroom. A green preventive maintenance sticker with the date 6/19/18 on it.
b. Major OR (O. R.- operating room): Two temperature (T)/humidity (H) monitors were noted. One stated: T-61 degrees Fahrenheit (F) and H-61 percent (%), and the second one stated: T-63.2 and H-62%. (Required levels=Humidity 20% to 60%" and Temperature 68 F to 75 F.)
c. Minor OR: T- 61 F and H- 62%. (Required levels=Humidity 20% to 60%" and Temperature 68 F to 75 F.)
d. There was no T/H monitor in the Endoscopy Room.

4. The O. R. Daily Work Checklists, dated 4/30/18 through 8/15/18, were reviewed on 8/15/18 at approximately 10:05 AM. The following were noted:
a. 1 out of 56 days lacked any documentation the T/H was checked.
b. 55 out of 55 recorded days, the "4. Temperature/Humidity" sections were signed with initials but lacked temperature numbers.
c. 47 out of 55 recorded days, the "4. Temperature/Humidity" sections were signed with initials but lacked humidity numbers.
d. 6 out of the 8 documented humidity numbers were greater than 60%, ranging 62% to 72%.
e. There was no documentation of supervisor and/or maintenance notification of the outlying humidity levels.

5. An interview was conducted with E#3 on 8/15/18 between approximately 9:40 AM and 11:10 AM. E#3 stated, "We follow AORN and our policy (for T/H). We (E#3 and the Director of Plant Operations- E#2) had concerns with the control of the humidity (in the Surgical Department) in June and July and were concerned we would have to close the OR (because of elevated humidity levels), so we got it (a dehumidifier) in case we needed it. We haven't used it. The date on the sticker (6/19/18) is when (E#2) checked it out before we used it." E#3 stated, "Our HVAC system has a system in it that notifies me and (E#2) if the temperature or humidity are a concern. We were not alerted of the outlying T/H levels today." E#3 reviewed the T/H logs (4/30/18 to 8/15/18) and stated, "We don't require them to put a number, just initial that they did them. If there is a number, it's probably the Major OR, but I'm not sure. No, we don't write down if we've called maintenance and we don't fill out any work requests."

6. An interview was conducted with E#2 on 8/15/18 at approximately 11:00 AM. E#2 stated, "I don't have exact dates for when the issues (T/H) have occurred. I know it's been awhile. I don't have any work orders. We (E#2 and E#3) just call each other. In June (2018), Anesthesia (E#11- Certified Registered Nurse Anesthetist) asked about a dehumidifier. (E#11) even went out and bought one to see if it would help bring the humidity down, but it was too small." At approximately 11:10 AM, E#3 and the Infection Preventionist (E#9) joined the interview. E#2 and E#3 both agreed the above mentioned humidity events and purchase of the dehumidifier occurred, but neither could say when the dehumidifier was bought, when it was used or how long the newly bought dehumidifier had been used. There was no documentation of these events. E#9 stated no knowledge that the surgery department was having any T/H issues/concerns.

7. The quarterly "Safety Dashboards" minutes, dated January 24, 2018, April 16, 2018, and July 11, 2018 were reviewed on 8/15/18 at approximately 12:30 PM. There was no documentation of the T/H issues in the Surgery Department.

8. A follow up interview was conducted with E#2 on 8/15/18 at approximately 2:15 PM. E#2 demonstrated a computer program that was set up to monitor the T/H of the CAH, as a whole. E#2 hovered over the area titled "Rm C188A-B Surgery Operating Rm" (the Major OR) and the screenshot stated the "Outside Air Humidity" was 43% and that the Major OR room temperature was 62.4 F. E#2 stated an alert was set up to notify E#2 and E#3 if the humidity reading would reach 50% "because then we would be concerned with potential issues in the OR. It doesn't mean the humidity in the OR is that high or low. We don't have it set up with alerts for temperatures (outlying temperatures in the OR)." E#3 joined the interview at approximately 2:25 PM. E#3 stated "That's not the way I thought it was set up." Both verbally agreed no official action plan to address the ongoing outlying Surgery Department T/H results had been developed and outlying T/H had not been communicated with the Safety Committee and/or the Infection Control Committee and should have been.

Based on observation, document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure its Infection Control program was followed, corrective action was taken, and ongoing monitoring to assure maintenance of corrective action was established to address identified and potential infection control events. This has the potential to affect all inpatients, outpatients, and visitors of the CAH.

Findings include:

1. The CAH failed to ensure the Infection Control Committee established an ongoing action plan to assure continued abatement of an identified mold event in one section of the roof top units requiring corrective action. See C-278A.

2. The CAH failed to ensure notification of designated personnel of infection control events that have the potential to cause harm to surgical patients, in accordance with its Infection Control Plan. See C-278B.

A. Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure the Infection Control Committee established an ongoing action plan to assure continued abatement of an identified mold in one section of the roof top units requiring corrective action. This has the potential to affect all inpatients, outpatients, and visitors of the CAH.

Findings include:

1. The quarterly "Safety Dashboards" minutes, dated January 2018, April 2018, and July 2018 were reviewed on 8/15/18 at approximately 12:30 PM.
a. The January Safety Dashboard minutes stated "Maint (maintenance) staff discovered what looked like mold in one section of all 5 roof top units ... were cleaned by... Maintenance will monitor ..."
b. The April Safety Dashboard minutes stated "continued monitoring shows no signs of mold returning in any roof top units. Summer would be prime season for this. Maintenance will continue to monitor."
c. The July Safety Dashboard minutes lacked any documentation as to the monitoring of the roof top units for mold.
d. There was no maintenance documentation of any of the follow up monitoring of the roof top units for mold.

2. The Infection Control and Operative and High Risk Committee meeting minutes dated February 15, 2018 and May 17, 2018 were reviewed on 8/15/18 at approximately 11:30 AM.
a. The February minutes stated "Other Business: -- Mold in Air Handling units ... These units were cleaned and will be cleaned on a regular basis. Dr ... did not feel these non-harmful molds will be a problem in general surgery cases but what about total joint replacements ... Dr ... offered to do some research in the molds."
b. The May meeting minutes lacked any follow up on the discussion. There was no documentation as to how often the air handling units were to be monitored and/or cleaned and/or how this would be incorporated into Quality for ongoing monitoring to assure continued mold abatement.

3. The Infection Prevention Plan 2018 (dated 07/2018) was reviewed on 8/15/18 at approximately 11:30 AM. The Plan stated "Design and implement effective intervention strategies to control the spread of infection and communicable disease and to promote safety while supporting the environment... Goals and Objectives... No mold was identified last year ... Our maintenance department makes weekly checks and the infection preventionist makes random site checks." There was no documentation of the mold event and no documentation of the maintenance and/or infection preventionist site checks.

4. An interview was conducted with the Director of Plant Operations (E#2) on 8/15/18 at approximately 12:30 PM. The Infection Preventionist (E#9) was present. E#9 stated "Yes, I'm aware of the mold issue and it has been cleaned up." E#2 stated "We (maintenance) do frequent checks (no frequency identified) because we're up there (on the roof top) all the time, but we don't write anything down that would show we are checking this (for the presence/absence of mold on the roof top units). We can start doing this." Both reviewed the Safety Dashboard and Infection Control minutes and verbally agreed there was no official action plan for ongoing monitoring of the identified mold event and there was no documentation of ongoing monitoring to assure the absence/reoccurrence of the mold.

B. Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure notification of designated personnel of infection control events that have the potential to cause harm to surgical patients, in accordance with its Infection Control Plan. This has the potential to affect all patients serviced by the CAH Surgical Department which performs an average of 56 surgical procedures monthly.

Findings include:

1. The Infection Prevention Plan 2018 was reviewed on 8/15/18 at approximately 11:30 AM. The Plan stated "Design and implement effective intervention strategies to control the spread of infection and communicable disease and to promote safety while supporting the environment... Goals and Objectives... 100% notifications of Infection Control when any issues arise that are known to the building and could potentially cause patient/staff harm..."

2. See C-226.

3. See C-320.

Based on observation, document review and interview, it was determined for 2 of 2 (Pts #1 and #2) surgical patients, the Critical Access Hospital (CAH) failed to ensure the outlying temperature and humidity (T/H) readings in the Surgical Department were acted upon to maintain a safe environment for the prevention of infection and failed to ensure identified infection control events known to potentially cause harm to patients were communicated to designated infection control personnel. This has the potential to affect all patients serviced by the CAH Surgical Department which performs an average of 56 surgical procedures monthly.

Findings include:

1. An observational tour of the Surgical Services area was conducted on 8/15/18, between approximately 9:30 AM and 10:20 AM, with the Director of Surgery and Obstetrics (E#3). The following were observed: Please see C-226.

2. The Quality Dashboards for January 2018 thru June of 2018 were reviewed on 8/15/18 at approximately 11:00 AM, during an interview with the Infection Preventionist (E#9). The Dashboard stated one surgical site infection (SSI) for the quarter "April, May, June". E#9 stated, "This patient (Pt #1) had a Laparoscopic Hysterectomy in May and was readmitted to another hospital with an abscess and had to have some further surgery. When I investigated it (the SSI), it was felt to be related to the length of surgery." When asked if the T/H of the OR was part of the evaluation as to determine the cause of the SSI, E#9 stated, "No. I didn't know that they (Surgery) was having any issues with the temperature and humidity."

3. A phone interview was conducted on 8/15/18 at approximately 1:30 PM with the Head of Surgery Department and Head of Infection Control (E#12- also Pt #1 and Pt #2's surgeon). E#12 stated being aware of the temperature/humidity concerns "early in June because I had a case (Pt #2) that I had to wait for it (humidity) to come down before we could do it (the surgery). I was told there was an inverse relationship with the temperature and humidity and our surgery, so we had to wait. I wasn't aware of the portable dehumidifier or that it was an ongoing problem."

4. An interview was conducted with the Director of Surgery and Obstetrics (E#3) on 8/15/18 at approximately 1:45 PM. E#3 stated "Yes, we did have a surgery that we had to wait for the humidity to go down and it was in June. That's the case (E#12) was talking about." At approximately 3:00 PM, E#3 presented a demographic sheet for Pt #2 which stated Pt #2 was admitted/discharged on 6/19/18 with the diagnosis of Dysfunctional Uterine Bleeding and underwent a Laparoscopic Total Abdominal Hysterectomy.

5. The O.R. Daily Work Checklist for 5/18/18 and 6/19/18 were reviewed on 8/15/18 at approximately 3:00 PM. The following was noted:
a. On 5/18/18, the checklist lacked a numerical value for the T/H.
b. On 6/19/18, the checklist lacked a numerical value for the T/H. The checklist further stated that on 6/18/18, the humidity was 62% and rechecked and was 72%. On 6/20/18, the humidity was 67%. On 6/21/18, the T/H area was blank. On 6/22/18, the humidity was 72%.
c. There was no documentation of supervisor and/or maintenance notification and/or corrective action being taken.

6. See C-278B