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Based on observation, interview and record review, the facility failed to ensure acceptable standards of infection control were followed and to assure surgical procedures were provided in a safe and sanitary manner to avoid potential sources of infection and transmission of infections and communicable disease by failing to:

1. Assure the operating room temperature and humidity was maintained in acceptable range. The facility did not address out of acceptable range temperature and humidity.
2. Prevent the use of an unsafe and unsanitary air-conditioning system in the operating room. The facility did not replace an unsafe air conditioning system in the operating room.
3. Follow manufacturer's guideline when using Immediate Use Steam Sterilizer #1 (AS#1) and Immediate Use Steam Sterilizer #2 (GS#2).

Findings:

1. During a tour of Hospital B Operating Room (OR) on 8/3/17 at 10:15 a.m. with: Chief Nursing Officer (CNO); Environmental Services (EVS) director and Quality Improvement (QI) director, out of range temperature and humidity was observed in the operating rooms (OR) including: OR#4 the Temperature (T) was 74 degree Fahrenheit (F) and Humidity (H) was 70%. Gastro Intestinal (GI) scopes were observed stored in cabinets in OR#4. In OR #OR#3, the temperature was 78F and humidity was70%.

During a tour of the Post Anesthesia Care Unit (PACU) the temperature was 74F and humidity was 70%. In the PACU Malignant hyperthermia medication was stored; Pyxis and crash cart were observed.

A recheck of temperature and humidity at 1:15 p.m. on 8/3/17 in OR#3 the temperature was 78F and humidity was 64% and OR#4 temperature was 76% and humidity was 72%.

During an interview with the CNO on 8/3/17 at 10:35 a.m., she indicated OR#3 and OR#4 were only in use and the remaining three operating rooms were not in use since 2014. When asked for the Nursing director for the Operating room she indicated there currently was no director for the Operating room. When asked if the surgeries scheduled for the morning would proceed she indicated if the temperature and humidity were out of range surgeries would be cancelled. When asked who checks temperature and humidity, CNO indicated the RN's in the OR check temperature and humidity at 7 am and notify EVS if temperature and humidity were out of range. EVS director indicated EVS also checks temperature and humidity.

A review of the monthly temperature and humidity logs, titled" Temperature and Humidity log for Operating Room" for EVS for 4/2017; 5/2017; 6/2017;7 /2017 and 8/2017 indicated multiple out of range readings each month for both temperature and humidity in the OR.

On 8/4/17 at 1:40 p.m. in the presence of the CNO and director of EVS, the facility director was interviewed. When asked for any documentation of discussion or meetings with the surgery department or Medical Executive Committee (MEC), Governing body repeated out of range Temperature and Humidity, the facility director stated there were none.

The MEC meeting minutes dated 4/27/17; 5/26/17; 6/29/17, Governing Body minutes dated 5/26/17 and Infection control meeting minutes dated 5/19/17 and 6/9/17 were reviewed. There was no documentation the out of range temperature and humidity in the OR was addressed and discussed.

A review of a service report completed by Company#1 dated 8/3/17, titled "Rooftop unit inspection/Evaluations serving the OR department" indicated " Overall the current units are either In-Operative or in poor operating conditions" including "Condensing coils are failing and impacted .... Interior compartments have failed and allowing outside air to enter the unit on the leaving side of the evaporator coils and contaminate conditions by mixing warm outside air and possibly cause room to operate outside of compliance parameters".

During an interview with MD#1 on 8/4/17 at 2:20 p.m., indicated all surgeries have been cancelled and patients will be transferred to general acute care hospital (GACH) #2 or GACH #3 if surgery is required. MD#1 indicated based on the finding of the service report on 8/3/17 on the HVAC report for the OR and in consultation with the CNO, Hospital B plans to install a new air conditioning unit for the OR.

A review of the facility policy and procedure titled, "Temperature and Humidity" dated 2/17 indicated OR environment "Acceptable temperature range is 68-73 degrees. Acceptable humidity range is 20-60%". A review of the facility policy and procedure titled "Medication storage" dated 2/17 indicated " Drugs shall be stored at appropriate temperatures, room temperature shall be between 68 degrees F and 77 degrees F".

2. During a tour of OR on 8/3/17 at 10:35 with CNO indicated there was no director of sterilization processing department (SPD) and no director of OR that she oversees the Operating room. CNO; EVS director and QI director indicated Immediate Use Steam Sterilizer #1 (AS#1) and Immediate Use Steam Sterilizer (IUSS) #2 (GS#2) were in use while Autoclave located in SPD was being replaced in August 2017. When asked if trays were weighed for sterilization in the immediate use steam sterilizers and how was the steam sterilizer used to sterilize larger items? QI director indicated the facility follows AAMI guidelines and manufacturer guidelines.

A review of the AAMI guidelines titled, "Table 5 Minimum cycle times for dynamic-air -removal steam sterilization cycles" dated 2013 page 83 and 84 indicate "for a specific sterilizer, consult only the manufacturer's recommendation" and "Cycle parameters vary depending on the design of the sterilizer. Only the sterilizer manufacturer is able to establish acceptable parameters" used by the facility to determine sterilization cycles using the IUSS while waiting for the installation of the autoclave indicated.

A review of the manufactures guideline for steam sterilizer AS#1 titled "[Brand Name] Steam Sterilizer" indicated parameters including instructions for steam sterilization under 17 lbs. and for 17 lbs. to 25 lbs. A review of the manufacturer's guidelines for GS#2 titled, "[Brand Name] steam sterilizer" undated indicated instructions for steam sterilizing including weight parameters for a maximum weight of 16 lbs.

On 8/3/17 at 2:55 p.m. during an interview with CNO, and Quality director, there were no scales used to weigh the instruments sterilized in AS#1 and GS#2 steam sterilizers. When asked for any documentation of discussion or meetings with the surgery department or MEC, Governing body as to how to determine the weight of the instruments sterilized in the immediate use steam sterilizers there were no documentations available for review. A review of MEC meeting 4/27/17; 5/26/17; 6/29/17 and Governing Body minutes 5/26/17 and Infection control 5/19/17 and 6/9/17 did not document addressing the weight limits when sterilizing in the steam sterilizersAS#1 and GS#2.

During an interview with biomedical director on 8/4/17 at 3:45 p.m. When asked for the current preventative maintenance (PM) for AS#1 and GS#2 he indicated last PM for AS#1 was 11/3/16 and last PM for GS#2 was 12/16/16 and both are overdue for PMs.

Based on observation, interview and record review, the facility leadership failed to ensure acceptable standards of infection control were followed and to assure surgical procedures were provided in a safe and sanitary manner to avoid potential sources of infection and transmission of infections and communicable disease by failing to:

1. Assure the operating room temperature and humidity was maintained in acceptable range. The facility did not address out of acceptable range temperature and humidity.
2. Prevent the use of an unsafe and unsanitary air-conditioning system in the operating room. The facility did not replace an unsafe air conditioning system in the operating room.
3. Follow manufacturer's guideline when using Immediate Use Steam Sterilizer #1 (AS#1) and Immediate Use Steam Sterilizer #2 (GS#2).

Findings:

1. During a tour of Hospital B Operating Room (OR) on 8/3/17 at 10:15 a.m. with: Chief Nursing Officer (CNO); Environmental Services (EVS) director and Quality Improvement (QI) director, out of range temperature and humidity was observed in the operating rooms (OR) including: OR#4 the Temperature (T) was 74 degree Fahrenheit (F) and Humidity (H) was 70%. Gastro Intestinal (GI) scopes were observed stored in cabinets in OR#4. In OR #OR#3, the temperature was 78F and humidity was 70%.

During a tour of the Post Anesthesia Care Unit (PACU) the temperature was 74F and humidity was 70%. In the PACU Malignant hyperthermia medication was stored; Pyxis and crash cart were observed.

A recheck of temperature and humidity at 1:15 p.m. on 8/3/17 in OR#3 the temperature was 78F and humidity was 64% and OR#4 temperature was 76% and humidity was 72%.

During an interview with the CNO on 8/3/17 at 10:35 a.m. she indicated OR#3 and OR#4 were only in use and the remaining three operating rooms were not in use since 2014. When asked for the Nursing director for the Operating room she indicated there currently was no director for the Operating room. When asked if the surgeries scheduled for the morning would proceed she indicated if the temperature and humidity were out of range surgeries would be canceled. When asked who checks temperature and humidity, CNO indicated the RN's in the OR check temperature and humidity at 7 am and notify EVS if temperature and humidity were out of range. EVS director indicated EVS also checks temperature and humidity.

A review of the monthly temperature and humidity logs, titled" Temperature and Humidity log for Operating Room" for EVS for 4/2017; 5/2017; 6/2017;7 /2017 and 8/2017 indicated multiple out of range readings each month for both temperature and humidity in the OR .

On 8/4/17 at 1:40 p.m. in the presence of the CNO and director of EVS, the facility director was interviewed. When asked for any documentation of discussion or meetings with the surgery department or medical executive committee (MEC), Governing body repeated out of range Temperature and Humidity, the facility director stated there was none.

The MEC meeting minutes dated 4/27/17; 5/26/17; 6/29/17, Governing Body minutes dated 5/26/17 and Infection control meeting minutes dated 5/19/17 and 6/9/17 were reviewed. There was no documentation the out of range temperature and humidity in the OR was addressed and discussed.

A review of a service report completed by Company#1 dated 8/3/17, titled "Rooftop unit inspection/Evaluations serving the OR department" indicated " Overall the current units are either In-Operative or in poor operating conditions" including "Condensing coils are failing and impacted .... Interior compartments have failed and allowing outside air to enter the unit on the leaving side of the evaporator coils and contaminate conditions by mixing warm outside air and possibly cause room to operate outside of compliance parameters".

During an interview with MD#1 on 8/4/17 at 2:20 p.m., indicated all surgeries have been canceled and patients will be transferred to general acute care hospital (GACH) #2 or GACH #3 if surgery is required. MD#1 indicated based on the finding of the service report on 8/3/17 on the HVAC report for the OR and in consultation with the CNO, Hospital B plans to install a new air conditioning unit for the OR.

A review of the facility policy and procedure titled, "Temperature and Humidity" dated 2/17 indicated OR environment "Acceptable temperature range is 68-73 degrees. Acceptable humidity range is 20-60%". A review of the facility policy and procedure titled "Medication storage" dated 2/17 indicated " Drugs shall be stored at appropriate temperatures, room temperature shall be between 68 degrees F and 77 degrees F".

2. During a tour of OR on 8/3/17 at 10:35 a.m. with CNO indicated there was no director of sterilization processing department (SPD) and no director of OR that she oversees the Operating room. CNO; EVS director and QI director indicated Immediate Use Steam Sterilizer #1 (AS#1) and Immediate Use Steam Sterilizer (IUSS) #2 (GS#2) were in use while Autoclave located in SPD was being replaced in August 2017. When asked if trays were weighed for sterilization in the immediate use steam sterilizers and how was the steam sterilizer used to sterilize larger items? QI director indicated the facility follows AAMI guidelines and manufacturer guidelines.

A review of the AAMI guidelines titled, "Table 5 Minimum cycle times for dynamic-air -removal steam sterilization cycles" dated 2013 page 83 and 84 indicate "for a specific sterilizer, consult only the manufacturer's recommendation" and "Cycle parameters vary depending on the design of the sterilizer. Only the sterilizer manufacturer is able to establish acceptable parameters" used by the facility to determine sterilization cycles using the IUSS while waiting for the installation of the autoclave indicated.

A review of the manufactures guideline for steam sterilizer AS#1 titled "[Brand Name] Steam Sterilizer" indicated parameters including instructions for steam sterilization under 17 lbs. and for 17 lbs. to 25 lbs. A review of the manufacturer's guidelines for GS#2 titled, "[Brand Name] steam sterilizer" undated indicated instructions for steam sterilizing including weight parameters for a maximum weight of 16 lbs.

On 8/3/17 at 2:55 p.m. during an interview with CNO, and Quality director, there were no scales used to weigh the instruments sterilized in AS#1 and GS#2 steam sterilizers. When asked for any documentation of discussion or meetings with the surgery department or MEC, Governing body as to how to determine the weight of the instruments sterilized in the immediate use steam sterilizers there were no documentation available for review. A review of MEC meeting 4/27/17; 5/26/17; 6/29/17 and Governing Body minutes 5/26/17 and Infection control 5/19/17 and 6/9/17 did not document addressing the weight limits when sterilizing in the steam sterilizers AS#1 and GS#2.

During an interview with biomedical director on 8/4/17 at 3:45 p.m. When asked for the current preventative maintenance (PM) for AS#1 and GS#2 he indicated last PM for AS#1 was 11/3/16 and last PM for GS#2 was 12/16/16 and both are overdue for PMs.