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Based on observation, interview and document review, the facility failed to maintain the medical air system in accordance with NFPA 99 Health Care Facilities. This was evidenced by the failure to repair identified problems with the medical air system, by no monitoring for the dew point, by no second dryer, and by breach of the medical air system without recertification. The dew point is the temperature at which air becomes saturated and produces moisture. This affected the Neonatal Intensive Care Unit, (NICU) and Post Partum Unit. This failure could result in potential harm to patients.

NFPA 99, Standard for Health Care Facilities 1999 Edition
2-2 Definitions
Medical Air* For purposes of this standard, medical air is air that
(a) Is supplied from cylinders, bulk containers, medical air compressors, or has been reconstituted from oxygen USP and nitrogen NF, and
(b) Complies with the following:
1. Medical Air USP
2. total hydrocarbons
liquid non-detectable
gaseous < 25 ppm
3. Pressure dew point at 50 psig < 39 F (4 degrees C)
4. Permanent particulates 5mg/m3 at normal atmospheric
pressure of particulate at
1 micron size or greater (PIP)

4-3.1.1.9 (g)* Accessories. Compressor systems for medical air shall be equipped with intake filter-mufflers of the dry type, aftercoolers or air dryers, or both, line filter(s) appropriate for the intake air conditions and compressor type, pressure regulators, and a pressure relief valve set at 50 percent above nominal line pressure to ensure the delivery of medical air (see definition of Medical Air in Section 2-2).
The medical air receiver shall be provided with a three-valve bypass to permit service to this device without shutting down the medical air system.
Dryer systems shall be, at a minimum, duplexed and valved to permit isolation of individual components to allow for maintenance or repair in the event of failure, while still continuing to adequately treat the flow of air. Under normal operation, only one dryer shall be open to airflow with the other dryer valved off. Each dryer system shall be designed to provide air at a maximum dew point of 35F (1.7 C) at the peak calculated demand of the system [See 4-3.1.2.2 (b) 3g.] System design shall preclude formation of liquid water in the air line.
Aftercoolers, where required, shall be duplexed and provided with individual condensate traps. The receiver shall not be used as an aftercooler or aftercooler trap.
Where more than two devices are provided, the peak calculated demand shall be met with the largest single unit out of service.
Final line filters located upstream of the final line regulators shall be duplexed with appropriate valves to permit service to these devices without shutting down the medical air system. Each of the filters shall be sized for 100 percent of the system peak calculated demand at design conditions and shall be rated for a minimum of 98 percent efficiency at 1 micron. These filters shall be equipped with a continuous visual indicator showing the status of the filter element life.
All final line regulators shall be multiplexed with isolating valves to permit service to the regulator without completely shutting down the gas piping system. Each of the regulators shall be sized for 100 percent of the system peak calculated demand at design condition.

4-3.4.1.1 Piped Gas Systems------Level 1
4-3.4.1.1* General. Inspection and testing shall be performed on all new piped gas systems, additions, renovations, temporary installations, or repaired systems, to assure the facility, by a documented procedure, that all applicable provisions of this document have been adhered to and system integrity has been achieved or maintained.
This inspection and testing shall include all components of the system or portions thereof including, but not limited to, gas bulk source(s), manifolds, compressed air source systems (e.g., compressors, dryers, filters, regulators), source alarms and monitoring safeguards, master alarms, pipelines, isolation valves, area alarms, zone valves, and station inlets (vacuum and outlets (pressure gases).

All systems that are breached and components that are subject to additions, renovations, or replacement (e.g., new gas sources-bulk, manifolds, compressors, dryers, alarms) shall be inspected and appropriately tested.
Systems shall be deemed breached at the point of pipeline intrusion by physical separation or by system component removal, replacement, or addition. The breached portions of the systems subject to inspection and testing shall be confined to only the specific altered zone and components in the immediate zone or area that is located upstream for vacuum systems and downstream for pressure gases at the point or area of intrusion.
The inspection and testing reports shall be verified and a certificate and submitted directly to the party that contracted for the testing. That party shall then submit the report through channels to the responsible authority and any others that are required. These reports shall contain detailed listings of all findings and results.
The responsible facility authority shall review these inspection and testing records prior to the use of all systems. This responsible facility authority shall ensure that all findings and results of the inspection and testing have been successfully completed, and all documentation pertaining thereto shall be maintained on-site within the facility.
Before piping system are initially put into use, the health care facility authority shall be responsible for ascertaining that the gas delivered at the outlet is that shown on the outlet label and that the proper connecting fittings are checked against their labels. This can be accomplished by accepting the results of 4-3.4.1.3, System Verification.
Manufactured assemblies shall, prior to arrival at the installation site, be pretested to comply with 4-3.4.1.2 (a) 4-3.4.1.2 (e) , except that 4-3.4.1.2 (c) shall be permitted to be performed by any leak testing method that will assure pressure decay of less than 1 percent in 24 hours. The manufacturer shall provide documentation attesting to the performance and successful completion of these tests.

4-3.4.1.4 Source Equipment Verification.
(b) Medical Air Compressor.
1. The proper functioning of the medical air system shall be tested before it is put into service. This shall include the purity test for air quality, and the test of the alarm sensors after calibration and setup per the manufacturer's instructions and automatic switchover as outlined in 4-3.1.1.9 (d) (2).
2. The following tests shall be conducted at the sample point of medical air system.
a. The operation of the system control sensors, such as dew point, air temperature , and all other air-quality monitoring sensors and controls, shall be checked for proper operation and function before the system is put into service.
b. The quality of medical air as delivered by the compressor air supply shall be verified after installation of new components prior to use by patients. The test shall be performed a minimum of 24 hours after continuous running of the machinery, at a sample port downstream of the pressure regulator and upstream of the piping system as defined in Figure 4-3.1.1.9. A demand of approximately 25 percent of the rated compressor capacity shall be created to cause the compressors to cycle on and off continuously and the dryers to operate for the 24-hour period.

Findings:

During a follow up telephone conference, about 2 p.m., on December 29, 2011, the facility provided additional information regarding their reported event about moisture in the medical air line. This was reported to the district office on December 28, 2012. During the interview, Staff 1, Staff 2, and Staff 3, stated that the facility had an incident on December 24, 2011 with moisture in the medical air line. Staff 3 reported the NICU medical air lines were affected. He reported there were no work orders or logs regarding action taken by maintenance staff for the problem.

Staff 1 stated that they were going to have a vendor on site on Saturday December 31, 2011, to repair to the system. Staff 1 stated the facility would notify the Life Safety Code Unit Chief on Friday, December 30, 2011, what time the vendor would be on site.

On December 30, 2011 at 12 p.m., the facility was contacted. Staff 1 stated that there was a vendor currently at the facility. Staff 1 stated the vendor arrived around 6 a.m., and was analyzing the system and not doing any repairs. Staff 1 stated a different vendor would be at the facility on Saturday December 31, 2011 to install the temporary desiccant air dryer. A desiccant dryer is used to remove moisture from the line.

On December 30, at 2:10 p.m., during the entrance conference, documentation was requested for the current incident in the NICU, as well as prior incidents pertaining to the medical air system. Documents for the inspections, testing and repairs for the medical air system and daily census for the NICU were requested.

At 2:25 p.m., during record review, Staff 2 confirmed an incident occurred on November 9, 2011, when NICU staff noticed water coming out from the "oxygen line." This incident was documented on the Nursing Administrative Daily Report dated November 9, 2011. The incident was reported to the Engineering Department.

Staff 2 stated that another incident was reported on November 28, 2011, when staff noticed an "Oxygen line" in NICU was squirting water from the line. Engineering was notified about the problem. Documentation was provided on the Nursing Administrative Daily Report dated November 28, 2011, which indicated "Oxygen line in NICU is squirting water from the line, engineering was notified."

The most current Nursing Administrative Daily Report for December 24, 2011, was not available at the time of the investigation.

At 2:26 p.m., records were requested for action taken by engineering staff after the moisture was reported in the "oxygen lines," on November 9, 2011 and November 28, 2011. Staff 3 stated there was no paperwork for checking the system. He stated it was not checked. Staff 2 stated the NICU had not been used ( beds in suspense) from September 19, 2011 through December 7, 2011.

At 2:33 p.m., during an interview, Staff 3 stated there was no paperwork for the November 9, 2011 occurrence or what actions plant operations staff took to resolve the problem. Staff 3 reported a refrigerated air dryer was installed sometime before Thanksgiving. He could not remember the date engineering staff installed the dryer.

Staff 3, was asked if the refrigerated air dryer was tested before and after the installation and he stated "no."

At 2:43 p.m., Staff 3 stated that the refrigerated air dryer was replaced before Thanksgiving. There was an extra one in the boiler room and plant operations staff replaced the old dryer with the spare. Staff 3 did not recall what date the dryer was changed. Staff 3 failed to document dew point readings after installation of the air dryer. There were no records of retesting after installation of a new component to the system.
There were no records for monitoring the medical air system as required.

Staff 1 stated "You are right we are not doing what we should be doing here."

At 3 p.m., during an interview, Vendor 1, who was evaluating the system, stated that light to moderate moisture was noted in the NICU and Post- Partum area lines. Vendor 1 stated the rooms affected were 115, 118, 120 and 122, in Post-Partum and 2 beds in NICU.

At 4 p.m., during a tour, with Staff 2, Staff 5 and Vendor 1, the NICU and Post-Partum areas were observed. Vendor 1 identified 2 of 2 beds in NICU and 7 of 9 beds in Post Partum that had moisture in the lines.

At 4:30 p.m., during an interview, Nursing Staff 1, in the Post- Partum/NICU area, was asked how the moisture was found in the NICU lines on December 24, 2011. Nursing Staff 1 stated that they were trying to stabilize a baby and when they disconnected the lines from the ventilator water came out.

There were no patients in the NICU during the tour. In Post Partum, Rooms 115, 118 and 122 had 1 patient, and there were 2 patients in Room 120. These patients were moved during the tour, to other rooms not affected.

At 5:07 p.m., during an interview, Staff 3 was asked if the system was breached when the refrigerated air dryer was replaced in November. Staff 3 stated he did not know if the system was breached.

On December 31, 2011, at 9 a.m., documentation dated December 30, 2011, was provided for the previous testing of the Medical Air System by Vendor 1 who was on-site. The report indicated there was moisture in the medical air lines. An e-mail report sent to Staff 3 from Vendor 2, on December 30, 2011, was also provided. The report from Vendor 2, dated December 29, 2011, identified problems with the Medical Air System and recommended 3 phases to bring the Medical Air System into compliance with NFPA 99.

At 9:05 a.m., Vendor 2 was on site to begin installation of the temporary desiccant air dryer.

At 9: 50 a.m., during an interview, Vendor 1 was asked if the system was breached at the time when the facility replaced the refrigerated air dryer back in November 2011. Vendor 1 stated "yes."

At 10:05 a.m., during an interview, Staff 3 was asked if the system was recertified after they installed the refrigerated air dryer in November 2011. He stated "no."

At 10:40 a.m., the system was back on line with the desiccant dryer installed and the refrigerated air dryer as a back up, per Vendor 1. Vendor 1 stated he would wait for 15 to 20 minutes and then would start testing the Dew point readings in the medical air lines. Vendor 2 reported that this is a temporary fix until a new desiccant air dryer is received by the facility.

At 10:56 a.m., during an interview, Staff 2 stated the facility will monitor dew point readings in the NICU and in the Post-Partum rooms affected. Once rooms have been cleared for use the facility will then monitor dew point readings in the boiler room and check affected rooms periodically.

At 11:05 a.m., Staff 3 reported "they fixed the monitor, it had been disconnected." The monitor was located in the boiler room, near the dryer.

On January 3, 2012, at about 10:45 a.m., the Nursing Administrative Daily Report dated December 24, 2011 was received. The report stated "NICU/Nursery is still having lots of water in the air line. Someone came and blew the line out earlier, but it doesn't seem to have done any good. A short while ago, this water blew out one of the LLMC vents(not today). When the line was blown out today, the water saturated a cloth diaper due to the large amount of H20."

On January 3, 2012, at 12 p.m., a copy of the work order dated November 7, 2011, was received via e-mail, showing the medical air dryer was replaced with a spare unit. The work order indicated the priority was high. No documentation was sent showing what the dew point readings were after installation, or if the system was re-certified.

On January 3, 2012, at 2:22 p.m., the November 2009 Medical Gas System Report was received. During review of the report for medical air (page 8 of 13) under comments "Dew Point Monitor was showing Error Code at Time of Inspection". No documentation was provided by the facility showing this had been repaired.

Based on observation, interview and document review, the facility failed to maintain the medical air system in accordance with NFPA 99 Health Care Facilities. This was evidenced by the failure to repair identified problems with the medical air system, by no monitoring for the dew point, by no second dryer, and by breach of the medical air system without recertification. The dew point is the temperature at which air becomes saturated and produces moisture. This affected the Neonatal Intensive Care Unit, (NICU) and Post Partum Unit. This failure could result in potential harm to patients.

NFPA 99, Standard for Health Care Facilities 1999 Edition
2-2 Definitions
Medical Air* For purposes of this standard, medical air is air that
(a) Is supplied from cylinders, bulk containers, medical air compressors, or has been reconstituted from oxygen USP and nitrogen NF, and
(b) Complies with the following:
1. Medical Air USP
2. total hydrocarbons
liquid non-detectable
gaseous < 25 ppm
3. Pressure dew point at 50 psig < 39 F (4 degrees C)
4. Permanent particulates 5mg/m3 at normal atmospheric
pressure of particulate at
1 micron size or greater (PIP)

4-3.1.1.9 (g)* Accessories. Compressor systems for medical air shall be equipped with intake filter-mufflers of the dry type, aftercoolers or air dryers, or both, line filter(s) appropriate for the intake air conditions and compressor type, pressure regulators, and a pressure relief valve set at 50 percent above nominal line pressure to ensure the delivery of medical air (see definition of Medical Air in Section 2-2).
The medical air receiver shall be provided with a three-valve bypass to permit service to this device without shutting down the medical air system.
Dryer systems shall be, at a minimum, duplexed and valved to permit isolation of individual components to allow for maintenance or repair in the event of failure, while still continuing to adequately treat the flow of air. Under normal operation, only one dryer shall be open to airflow with the other dryer valved off. Each dryer system shall be designed to provide air at a maximum dew point of 35F (1.7 C) at the peak calculated demand of the system [See 4-3.1.2.2 (b) 3g.] System design shall preclude formation of liquid water in the air line.
Aftercoolers, where required, shall be duplexed and provided with individual condensate traps. The receiver shall not be used as an aftercooler or aftercooler trap.
Where more than two devices are provided, the peak calculated demand shall be met with the largest single unit out of service.
Final line filters located upstream of the final line regulators shall be duplexed with appropriate valves to permit service to these devices without shutting down the medical air system. Each of the filters shall be sized for 100 percent of the system peak calculated demand at design conditions and shall be rated for a minimum of 98 percent efficiency at 1 micron. These filters shall be equipped with a continuous visual indicator showing the status of the filter element life.
All final line regulators shall be multiplexed with isolating valves to permit service to the regulator without completely shutting down the gas piping system. Each of the regulators shall be sized for 100 percent of the system peak calculated demand at design condition.

4-3.4.1.1 Piped Gas Systems------Level 1
4-3.4.1.1* General. Inspection and testing shall be performed on all new piped gas systems, additions, renovations, temporary installations, or repaired systems, to assure the facility, by a documented procedure, that all applicable provisions of this document have been adhered to and system integrity has been achieved or maintained.
This inspection and testing shall include all components of the system or portions thereof including, but not limited to, gas bulk source(s), manifolds, compressed air source systems (e.g., compressors, dryers, filters, regulators), source alarms and monitoring safeguards, master alarms, pipelines, isolation valves, area alarms, zone valves, and station inlets (vacuum and outlets (pressure gases).

All systems that are breached and components that are subject to additions, renovations, or replacement (e.g., new gas sources-bulk, manifolds, compressors, dryers, alarms) shall be inspected and appropriately tested.
Systems shall be deemed breached at the point of pipeline intrusion by physical separation or by system component removal, replacement, or addition. The breached portions of the systems subject to inspection and testing shall be confined to only the specific altered zone and components in the immediate zone or area that is located upstream for vacuum systems and downstream for pressure gases at the point or area of intrusion.
The inspection and testing reports shall be verified and a certificate and submitted directly to the party that contracted for the testing. That party shall then submit the report through channels to the responsible authority and any others that are required. These reports shall contain detailed listings of all findings and results.
The responsible facility authority shall review these inspection and testing records prior to the use of all systems. This responsible facility authority shall ensure that all findings and results of the inspection and testing have been successfully completed, and all documentation pertaining thereto shall be maintained on-site within the facility.
Before piping system are initially put into use, the health care facility authority shall be responsible for ascertaining that the gas delivered at the outlet is that shown on the outlet label and that the proper connecting fittings are checked against their labels. This can be accomplished by accepting the results of 4-3.4.1.3, System Verification.
Manufactured assemblies shall, prior to arrival at the installation site, be pretested to comply with 4-3.4.1.2 (a) 4-3.4.1.2 (e) , except that 4-3.4.1.2 (c) shall be permitted to be performed by any leak testing method that will assure pressure decay of less than 1 percent in 24 hours. The manufacturer shall provide documentation attesting to the performance and successful completion of these tests.

4-3.4.1.4 Source Equipment Verification.
(b) Medical Air Compressor.
1. The proper functioning of the medical air system shall be tested before it is put into service. This shall include the purity test for air quality, and the test of the alarm sensors after calibration and setup per the manufacturer's instructions and automatic switchover as outlined in 4-3.1.1.9 (d) (2).
2. The following tests shall be conducted at the sample point of medical air system.
a. The operation of the system control sensors, such as dew point, air temperature , and all other air-quality monitoring sensors and controls, shall be checked for proper operation and function before the system is put into service.
b. The quality of medical air as delivered by the compressor air supply shall be verified after installation of new components prior to use by patients. The test shall be performed a minimum of 24 hours after continuous running of the machinery, at a sample port downstream of the pressure regulator and upstream of the piping system as defined in Figure 4-3.1.1.9. A demand of approximately 25 percent of the rated compressor capacity shall be created to cause the compressors to cycle on and off continuously and the dryers to operate for the 24-hour period.

Findings:

During a follow up telephone conference, about 2 p.m., on December 29, 2011, the facility provided additional information regarding their reported event about moisture in the medical air line. This was reported to the district office on December 28, 2012. During the interview, Staff 1, Staff 2, and Staff 3, stated that the facility had an incident on December 24, 2011 with moisture in the medical air line. Staff 3 reported the NICU medical air lines were affected. He reported there were no work orders or logs regarding action taken by maintenance staff for the problem.

Staff 1 stated that they were going to have a vendor on site on Saturday December 31, 2011, to repair to the system. Staff 1 stated the facility would notify the Life Safety Code Unit Chief on Friday, December 30, 2011, what time the vendor would be on site.

On December 30, 2011 at 12 p.m., the facility was contacted. Staff 1 stated that there was a vendor currently at the facility. Staff 1 stated the vendor arrived around 6 a.m., and was analyzing the system and not doing any repairs. Staff 1 stated a different vendor would be at the facility on Saturday December 31, 2011 to install the temporary desiccant air dryer. A desiccant dryer is used to remove moisture from the line.

On December 30, at 2:10 p.m., during the entrance conference, documentation was requested for the current incident in the NICU, as well as prior incidents pertaining to the medical air system. Documents for the inspections, testing and repairs for the medical air system and daily census for the NICU were requested.

At 2:25 p.m., during record review, Staff 2 confirmed an incident occurred on November 9, 2011, when NICU staff noticed water coming out from the "oxygen line." This incident was documented on the Nursing Administrative Daily Report dated November 9, 2011. The incident was reported to the Engineering Department.

Staff 2 stated that another incident was reported on November 28, 2011, when staff noticed an "Oxygen line" in NICU was squirting water from the line. Engineering was notified about the problem. Documentation was provided on the Nursing Administrative Daily Report dated November 28, 2011, which indicated "Oxygen line in NICU is squirting water from the line, engineering was notified."

The most current Nursing Administrative Daily Report for December 24, 2011, was not available at the time of the investigation.

At 2:26 p.m., records were requested for action taken by engineering staff after the moisture was reported in the "oxygen lines," on November 9, 2011 and November 28, 2011. Staff 3 stated there was no paperwork for checking the system. He stated it was not checked. Staff 2 stated the NICU had not been used ( beds in suspense) from September 19, 2011 through December 7, 2011.

At 2:33 p.m., during an interview, Staff 3 stated there was no paperwork for the November 9, 2011 occurrence or what actions plant operations staff took to resolve the problem. Staff 3 reported a refrigerated air dryer was installed sometime before Thanksgiving. He could not remember the date engineering staff installed the dryer.

Staff 3, was asked if the refrigerated air dryer was tested before and after the installation and he stated "no."

At 2:43 p.m., Staff 3 stated that the refrigerated air dryer was replaced before Thanksgiving. There was an extra one in the boiler room and plant operations staff replaced the old dryer with the spare. Staff 3 did not recall what date the dryer was changed. Staff 3 failed to document dew point readings after installation of the air dryer. There were no records of retesting after installation of a new component to the system.
There were no records for monitoring the medical air system as required.

Staff 1 stated "You are right we are not doing what we should be doing here."

At 3 p.m., during an interview, Vendor 1, who was evaluating the system, stated that light to moderate moisture was noted in the NICU and Post- Partum area lines. Vendor 1 stated the rooms affected were 115, 118, 120 and 122, in Post-Partum and 2 beds in NICU.

At 4 p.m., during a tour, with Staff 2, Staff 5 and Vendor 1, the NICU and Post-Partum areas were observed. Vendor 1 identified 2 of 2 beds in NICU and 7 of 9 beds in Post Partum that had moisture in the lines.

At 4:30 p.m., during an interview, Nursing Staff 1, in the Post- Partum/NICU area, was asked how the moisture was found in the NICU lines on December 24, 2011. Nursing Staff 1 stated that they were trying to stabilize a baby and when they disconnected the lines from the ventilator water came out.

There were no patients in the NICU during the tour. In Post Partum, Rooms 115, 118 and 122 had 1 patient, and there were 2 patients in Room 120. These patients were moved during the tour, to other rooms not affected.

At 5:07 p.m., during an interview, Staff 3 was asked if the system was breached when the refrigerated air dryer was replaced in November. Staff 3 stated he did not know if the system was breached.

On December 31, 2011, at 9 a.m., documentation dated December 30, 2011, was provided for the previous testing of the Medical Air System by Vendor 1 who was on-site. The report indicated there was moisture in the medical air lines. An e-mail report sent to Staff 3 from Vendor 2, on December 30, 2011, was also provided. The report from Vendor 2, dated December 29, 2011, identified problems with the Medical Air System and recommended 3 phases to bring the Medical Air System into compliance with NFPA 99.

At 9:05 a.m., Vendor 2 was on site to begin installation of the temporary desiccant air dryer.

At 9: 50 a.m., during an interview, Vendor 1 was asked if the system was breached at the time when the facility replaced the refrigerated air dryer back in November 2011. Vendor 1 stated "yes."

At 10:05 a.m., during an interview, Staff 3 was asked if the system was recertified after they installed the refrigerated air dryer in November 2011. He stated "no."

At 10:40 a.m., the system was back on line with the desiccant dryer installed and the refrigerated air dryer as a back up, per Vendor 1. Vendor 1 stated he would wait for 15 to 20 minutes and then would start testing the Dew point readings in the medical air lines. Vendor 2 reported that this is a temporary fix until a new desiccant air dryer is received by the facility.

At 10:56 a.m., during an interview, Staff 2 stated the facility will monitor dew point readings in the NICU and in the Post-Partum rooms affected. Once rooms have been cleared for use the facility will then monitor dew point readings in the boiler room and check affected rooms periodically.

At 11:05 a.m., Staff 3 reported "they fixed the monitor, it had been disconnected." The monitor was located in the boiler room, near the dryer.

On January 3, 2012, at about 10:45 a.m., the Nursing Administrative Daily Report dated December 24, 2011 was received. The report stated "NICU/Nursery is still having lots of water in the air line. Someone came and blew the line out earlier, but it doesn't seem to have done any good. A short while ago, this water blew out one of the LLMC vents(not today). When the line was blown out today, the water saturated a cloth diaper due to the large amount of H20."

On January 3, 2012, at 12 p.m., a copy of the work order dated November 7, 2011, was received via e-mail, showing the medical air dryer was replaced with a spare unit. The work order indicated the priority was high. No documentation was sent showing what the dew point readings were after installation, or if the system was re-certified.

On January 3, 2012, at 2:22 p.m., the November 2009 Medical Gas System Report was received. During review of the report for medical air (page 8 of 13) under comments "Dew Point Monitor was showing Error Code at Time of Inspection". No documentation was provided by the facility showing this had been repaired.