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Based on document review and interview, the Hospital failed to maintain their heating and ventilation humidity system as evidenced by the operating room humidity levels dropping below the CMS minimum 35% minimum levels on more than one occurrence in more than one operating room during the last six months, and by the occurrence of misting in more than one operating room on more than occasion during the last six months. These deficient practices could lead to an increased possibility of an electro static operating room fire, and a decrease in infection control measures, and affected all patients and staff in the operating room when such deficient practices occurred.

NFPA 101, 2000 Edition.
19.3.2.3 Anesthetizing Locations. Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.

NFPA 99. 1999 Edition
Chapter 5 Environmental Systems
5-1* Scope. This chapter covers the performance, maintenance, and testing of the environmental systems used within health care facilities.

5-4.1* Ventilation-Anesthetizing Locations.
5-4.1.1* The mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 35 percent or greater.

NFPA 101, 2000 Edition
19.5.2, heating, Ventilating, and Air Conditioning
19.5.2.1, Heating, ventilating, and air conditioning shall comply with the provisions of section 9.2 and shall be installed in accordance with the manufacturer's specifications.

NFPA 101, 2000 Edition,
9.2.1, Air conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating, and Air Conditioning Systems, as applicable unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.

NFPA 90A, 1999 Edition,
2-1.3, Equipment shall be guarded for personal protection and against the intake of foreign matter into the system.

NFPA 90B, 1999 Edition,
4-3.3, Air for Combustion and Ventilation.
Heating appliances shall be installed in a location in which the facilities for ventilation provide for combustion and proper ventilation under normal conditions of operation and use.

Findings:

During the investigation of an entity reported event CA00311724 at the Hospital on 5/18/2012, and during phone conversations with the Hospital Staff and Professional vendors on 6/18/2012, the Hospital's humidity control system policy was reviewed.

The ERI CA00311724 states,
" On 3/9/2012, a patient had a craniotomy procedure in the operating room. During the surgical procedure, a mist from the vent on the OR showered the sterile operative cranial wound with non-sterile water. As a result, the surgery went from being a clean wound to contaminated wound."

In an interview with the Engineer on 3/18/2012, the staff stated that the hospital followed OSHPD minimum humidly levels of 30%, and not the current CMS minimum level of 35%.

A facility memo to CDPH dated 5/17/2012 stated that the humidity levels in operating rooms were lower than 30% on 1/17/2012. The memo stated that some components, primarily valves used to generate steam to humidify the rooms, had either failed or were not operating properly. By mid March, 2012, the memo stated that vendors had replaced faulty valves and other components of the humidifying system, but that the humidity levels continued to fluctuate. The memo concludes with the statement that a professional vendor will be hired to modify the system to better control the humidity levels.

On 5/18/2012, during an interview with a Hospital Engineer and Operating Room nurse, staff stated that misting had occurred in the OR room on the 3/9/2012 date, and presented an official OR room humidity and temperature log for operating rooms 1-12 for the date of 3/9/2012. While OR room 10, where the actual 3/9/2012 misting occurred had a minimum humidity level of 41.4, OR rooms 1 and 2 had minimum humidity levels at 32.2 and 33.9 on the 3/9/2012 date.

The Hospital memo and related flow chart states there was a problem with misting and humidity levels at various times over the course of the first five months of 2012.

Based on the entity reported event of 3/9/2012, the hospital memo dated 5/17/2012, and interviews with staff, 5/18/201 and 6/18/2012, the hospital had failed to follow the CMS minimum humidity level of 35%.

On 6/18/2012, during a conversation with the professional vendor hired to modify the humidly system at the hospital and in review of the vendor proposed modification documents dated 5/18/2012, the documents showed that the prior existing faulty steam control valves which are related to the misting issue had caused the hospital to close operating rooms 1 and 5 for some time pending repairs. The documentation did not show operating room 10 to be in need of repair at the time. The documentation did show a general modification of all operating room humidity control systems. As of 6/18/2012, the modification work was in progress or had been completed at the time.

Based on document review and interview, the Hospital ailed to maintain their heating and ventilation humidity system as evidenced by the operating room humidity levels dropping below the CMS minimum 35% minimum levels on more than one occurrence in more than one operating room during the last six months, and by the occurrence of misting in more than one operating room on more than occasion during the last six months. These deficient practices could lead to an increased possibility of an electro static operating room fire and a decrease in infection control measures and affected all patients and staff in the operating room when such deficient practices occurred.

NFPA 101, 2000 Edition.
19.3.2.3 Anesthetizing Locations. Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.

NFPA 99. 1999 Edition
Chapter 5 Environmental Systems
5-1* Scope. This chapter covers the performance, maintenance, and testing of the environmental systems used within health care facilities.

5-4.1* Ventilation-Anesthetizing Locations.
5-4.1.1* The mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 35 percent or greater.

NFPA 101, 2000 Edition
19.5.2, heating, Ventilating, and Air Conditioning
19.5.2.1, Heating, ventilating, and air conditioning shall comply with the provisions of section 9.2 and shall be installed in accordance with the manufacturer's specifications.

NFPA 101, 2000 Edition,
9.2.1, Air conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating, and Air Conditioning Systems, as applicable unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.

NFPA 90A, 1999 Edition,
2-1.3, Equipment shall be guarded for personal protection and against the intake of foreign matter into the system.

NFPA 90B, 1999 Edition,
4-3.3, Air for Combustion and Ventilation.
Heating appliances shall be installed in a location in which the facilities for ventilation provide for combustion and proper ventilation under normal conditions of operation and use.

Findings:

During the investigation of an entity reported event CA00311724 at the Hospital on 5/18/2012 and during phone conversations with the Hospital Staff and Professional vendors on 6/18/2012, the Hospital's humidity control system policy was reviewed.

The ERI CA00311724 reads:

" On 3/9/2012, a patient had a craniotomy procedure in the operating room. During the surgical procedure, a mist from the vent on the OR showered the sterile operative cranial wound with non-sterile water. As a result, the surgery went from being a clean wound to contaminated wound."

In an interview, with the Engineer on 3/18/2012, the staff stated that the hospital followed OSHPD minimum humidly levels of 30% and not the current CMS minimum level of 35%.

A facility memo to CDPH dated 5/17/2012 states that the humidity levels in operating rooms were lower than 30% on 1/17/2012. The memo states that some components, primarily valves used to generate steam to humidify the rooms had either failed or were not operating properly. By mid March, 2012, the memo states that vendors had replaced faulty valves and other components of the humidifying system, but that the humidity levels continued to fluctuate. The memo concludes with the statement that a professional vendor will be hired to modify the system to better control the humidity levels.

On 5/18/2012, during an interview with a Hospital Engineer and Operating Room nurse, staff stated that misting had occurred in the OR room on the 3/9/2012 date and presented an official OR room humidity and temperature log for operating rooms 1-12 for the date of 3/9/2012. While OR room 10, where the actual 3/9/2012 misting occurred had a minimum humidity level of 41.4, OR rooms 1 and 2 had minimum humidity levels at 32.2 and 33.9 on the 3/9/2012 date.

The Hospital memo and related flow chart states there was a problem with misting and humidity levels at various times over the course of the first five months of 2012.

Based on the entity reported event of 3/9/2012, the hospital memo dated 5/17/2012, and interviews with staff, 5/18/201 and 6/18/2012, the hospital had failed to follow the CMS minimum humidity level of 35%

On 6/18/2012, during a conversation with the professional vendor hired to modify the humidly system at the hospital and in review of the vendor proposed modification documents dated 5/18/2012, the documents showed that the prior existing faulty steam control valves which are related to the misting issue had caused the hospital to close operating rooms 1 and 5 for some time pending repairs. The documentation did not show operating room 10 to be in need of repair at the time. The documentation did show a general modification of all operating room humidity control systems. As of 6/18/2012, the modification work was in progress or had been completed at the time.

Based on document review and interview, the Hospital failed to maintain their heating and ventilation humidity system as evidenced by the operating room humidity levels dropping below the CMS minimum 35% minimum levels on more than one occurrence in more than one operating room during the last six months, and by the occurrence of misting in more than one operating room on more than occasion during the last six months. These deficient practices could lead to an increased possibility of an electro static operating room fire, and a decrease in infection control measures, and affected all patients and staff in the operating room when such deficient practices occurred.

NFPA 101, 2000 Edition.
19.3.2.3 Anesthetizing Locations. Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.

NFPA 99. 1999 Edition
Chapter 5 Environmental Systems
5-1* Scope. This chapter covers the performance, maintenance, and testing of the environmental systems used within health care facilities.

5-4.1* Ventilation-Anesthetizing Locations.
5-4.1.1* The mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 35 percent or greater.

NFPA 101, 2000 Edition
19.5.2, heating, Ventilating, and Air Conditioning
19.5.2.1, Heating, ventilating, and air conditioning shall comply with the provisions of section 9.2 and shall be installed in accordance with the manufacturer's specifications.

NFPA 101, 2000 Edition,
9.2.1, Air conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating, and Air Conditioning Systems, as applicable unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.

NFPA 90A, 1999 Edition,
2-1.3, Equipment shall be guarded for personal protection and against the intake of foreign matter into the system.

NFPA 90B, 1999 Edition,
4-3.3, Air for Combustion and Ventilation.
Heating appliances shall be installed in a location in which the facilities for ventilation provide for combustion and proper ventilation under normal conditions of operation and use.

Findings:

During the investigation of an entity reported event CA00311724 at the Hospital on 5/18/2012, and during phone conversations with the Hospital Staff and Professional vendors on 6/18/2012, the Hospital's humidity control system policy was reviewed.

The ERI CA00311724 states,
" On 3/9/2012, a patient had a craniotomy procedure in the operating room. During the surgical procedure, a mist from the vent on the OR showered the sterile operative cranial wound with non-sterile water. As a result, the surgery went from being a clean wound to contaminated wound."

In an interview with the Engineer on 3/18/2012, the staff stated that the hospital followed OSHPD minimum humidly levels of 30%, and not the current CMS minimum level of 35%.

A facility memo to CDPH dated 5/17/2012 stated that the humidity levels in operating rooms were lower than 30% on 1/17/2012. The memo stated that some components, primarily valves used to generate steam to humidify the rooms, had either failed or were not operating properly. By mid March, 2012, the memo stated that vendors had replaced faulty valves and other components of the humidifying system, but that the humidity levels continued to fluctuate. The memo concludes with the statement that a professional vendor will be hired to modify the system to better control the humidity levels.

On 5/18/2012, during an interview with a Hospital Engineer and Operating Room nurse, staff stated that misting had occurred in the OR room on the 3/9/2012 date, and presented an official OR room humidity and temperature log for operating rooms 1-12 for the date of 3/9/2012. While OR room 10, where the actual 3/9/2012 misting occurred had a minimum humidity level of 41.4, OR rooms 1 and 2 had minimum humidity levels at 32.2 and 33.9 on the 3/9/2012 date.

The Hospital memo and related flow chart states there was a problem with misting and humidity levels at various times over the course of the first five months of 2012.

Based on the entity reported event of 3/9/2012, the hospital memo dated 5/17/2012, and interviews with staff, 5/18/201 and 6/18/2012, the hospital had failed to follow the CMS minimum humidity level of 35%.

On 6/18/2012, during a conversation with the professional vendor hired to modify the humidly system at the hospital and in review of the vendor proposed modification documents dated 5/18/2012, the documents showed that the prior existing faulty steam control valves which are related to the misting issue had caused the hospital to close operating rooms 1 and 5 for some time pending repairs. The documentation did not show operating room 10 to be in need of repair at the time. The documentation did show a general modification of all operating room humidity control systems. As of 6/18/2012, the modification work was in progress or had been completed at the time.

Based on document review and interview, the Hospital ailed to maintain their heating and ventilation humidity system as evidenced by the operating room humidity levels dropping below the CMS minimum 35% minimum levels on more than one occurrence in more than one operating room during the last six months, and by the occurrence of misting in more than one operating room on more than occasion during the last six months. These deficient practices could lead to an increased possibility of an electro static operating room fire and a decrease in infection control measures and affected all patients and staff in the operating room when such deficient practices occurred.

NFPA 101, 2000 Edition.
19.3.2.3 Anesthetizing Locations. Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.

NFPA 99. 1999 Edition
Chapter 5 Environmental Systems
5-1* Scope. This chapter covers the performance, maintenance, and testing of the environmental systems used within health care facilities.

5-4.1* Ventilation-Anesthetizing Locations.
5-4.1.1* The mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 35 percent or greater.

NFPA 101, 2000 Edition
19.5.2, heating, Ventilating, and Air Conditioning
19.5.2.1, Heating, ventilating, and air conditioning shall comply with the provisions of section 9.2 and shall be installed in accordance with the manufacturer's specifications.

NFPA 101, 2000 Edition,
9.2.1, Air conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating, and Air Conditioning Systems, as applicable unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.

NFPA 90A, 1999 Edition,
2-1.3, Equipment shall be guarded for personal protection and against the intake of foreign matter into the system.

NFPA 90B, 1999 Edition,
4-3.3, Air for Combustion and Ventilation.
Heating appliances shall be installed in a location in which the facilities for ventilation provide for combustion and proper ventilation under normal conditions of operation and use.

Findings:

During the investigation of an entity reported event CA00311724 at the Hospital on 5/18/2012 and during phone conversations with the Hospital Staff and Professional vendors on 6/18/2012, the Hospital's humidity control system policy was reviewed.

The ERI CA00311724 reads:

" On 3/9/2012, a patient had a craniotomy procedure in the operating room. During the surgical procedure, a mist from the vent on the OR showered the sterile operative cranial wound with non-sterile water. As a result, the surgery went from being a clean wound to contaminated wound."

In an interview, with the Engineer on 3/18/2012, the staff stated that the hospital followed OSHPD minimum humidly levels of 30% and not the current CMS minimum level of 35%.

A facility memo to CDPH dated 5/17/2012 states that the humidity levels in operating rooms were lower than 30% on 1/17/2012. The memo states that some components, primarily valves used to generate steam to humidify the rooms had either failed or were not operating properly. By mid March, 2012, the memo states that vendors had replaced faulty valves and other components of the humidifying system, but that the humidity levels continued to fluctuate. The memo concludes with the statement that a professional vendor will be hired to modify the system to better control the humidity levels.

On 5/18/2012, during an interview with a Hospital Engineer and Operating Room nurse, staff stated that misting had occurred in the OR room on the 3/9/2012 date and presented an official OR room humidity and temperature log for operating rooms 1-12 for the date of 3/9/2012. While OR room 10, where the actual 3/9/2012 misting occurred had a minimum humidity level of 41.4, OR rooms 1 and 2 had minimum humidity levels at 32.2 and 33.9 on the 3/9/2012 date.

The Hospital memo and related flow chart states there was a problem with misting and humidity levels at various times over the course of the first five months of 2012.

Based on the entity reported event of 3/9/2012, the hospital memo dated 5/17/2012, and interviews with staff, 5/18/201 and 6/18/2012, the hospital had failed to follow the CMS minimum humidity level of 35%

On 6/18/2012, during a conversation with the professional vendor hired to modify the humidly system at the hospital and in review of the vendor proposed modification documents dated 5/18/2012, the documents showed that the prior existing faulty steam control valves which are related to the misting issue had caused the hospital to close operating rooms 1 and 5 for some time pending repairs. The documentation did not show operating room 10 to be in need of repair at the time. The documentation did show a general modification of all operating room humidity control systems. As of 6/18/2012, the modification work was in progress or had been completed at the time.