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Based upon record review, obsevation and interview the facility failed to: 1) Implement improvement actions that will measure, analyze, and track to reduce the risk of medical errors for 3 out of 12 sampled patients (SP) #2, and (SP) #3 as a result of an adverse event involving sampled patient (#1), and 2) To assume full responsibility to ensure that the quality assessment and improvement efforts address priorities for patient safety, and that all improvement actions are implemented and maintained in the resterilization of the sterile trays in the Central Sterile Storage Area.

The findings include:

1. Refer to the findings at A-0286.

2. Refer to the findings at A-0309.

Based upon record review and interview, the facility failed to assure the Surgical Services Department achieves and maintain a high standard of medical practice and patient care by ensuring: 1) The surgical sponge counts are conducted according to the policy in 3 out of 12 sampled patients (SP) #1, #2 and #3; and 2) The re-sterilization of the Orthro/Neuro trays located in the Central Sterile Storage area after a ceiling leak.

The findings include:

1. Refer to the findings at A-0951.

2. Refer to the findings at A-0955.

Based upon record review and interview, the facility failed to implement improvement actions that will measure, analyze, and track to reduce the risk of medical errors for 2 out of 12 sampled patients (SP) #2, and (SP) #3 as a result of an adverse event involving sampled patient (#1).

The findings include:

1. Sampled Patient (SP#1) was admitted to the facility on 01/27/14. Review of the patient's medical record reveals that the 1st surgery (coronary artery bypass) started at 9:01am and ended at 1:15pm. The patient left the OR (Operating Room) and was transferred to the CCU (Critical Care Unit). Further review of the Surgical Case Record documents that there was 3 surgical counts conducted during the surgery. The count included instruments, laps (sponges), blades, needles, booties, and misc. (miscellaneous). The Nurse's Notes on 01/28/14 document that the patient was received in CCU and was transferred back to the OR (Operating Room) by the OR team for a foreign body removal. The Surgical Case Record for the chest re-exploration (second surgery) documents that the patient arrived backed to the OR room at 3:23pm for the chest re-exploration. The Operative Report, dictated by the surgeon, on 01/28/14 has that a re-exploration and removal of a lap pad was performed. The Operative Note also states, the patient underwent an uneventful coronary artery bypass earlier today. The results of his chest x-ray revealed, the patient was found to have a retained lap pad and he was brought to the operating room presently for removal.
SP#1 patient ' s medical records show that there were 3 Circulating Registered Nurses (RN) and 2 Surgical Techs for the CABG surgery on 01/28/14. Sampled Employee (SE) #1 & #3 were Circulating Nurses and SE#2 was one of the Surgical Techs for SP#1.
In an interview with sampled employee (SE) #1 on 02/12/14 at 3:14pm, the Circulating RN states, I was relieving [name of SE#3] for lunch. We counted. I thought I had the correct count. [Name of SE#3] was the Circulating Nurse. I came at 12pm. I looked on the board to see the count before. I discovered when I got there that the count was wrong. There were initially 40 laps and there were only 39. We searched and looked for the lap. There were 9 on the table and 30 in the bags. I counted three times. I looked around for the one. I rang them into the machine 3 times and on the 4th count, there was a lap in the bucket in the Clear Count Machine. It appeared in the clear count bucket. I didn't put it in the bucket. I thought the scrub tech threw it there. It just appeared there. I counted again and it was 40. I assumed the lap fell out of the bucket and someone put it back in the bucket. [Name of SE#3] came back from lunch, saw it was 40 and I moved on. I came back to the room after the surgery to clear the count and saw that it was not correct. It was saying 39 (thirty-nine). I had held up the surgery because of the miscount. I couldn't find the lap. I dreaded it ended up in a patient. I went to scan the patient with the wand and brought the patient back.
In an interview with SE#3 on 02/12/14 at 3:35pm, the Circulating RN states, I was gone to lunch, when I came back from lunch, I was told that we were missing a sponge. We started looking, we couldn't find a sponge. We counted the field, there were 9. [Name of SE#1] had one in his hands from the bucket. We counted the field again. One was in the bucket, and 30(thirty) off the field. We thought we had the correct count at the time. I did not open the bags to see what was in each of the 3 bags. This was the final count. We left the room, later we realized we left the sponge. I did not clear the Clear Count. To clear the Clear Count machine, we put everything in the bucket. That was not done prior to the patient leaving. I forgot to check the Clear Count Machine. After the incident, we had meetings, completed an analysis, and we had meeting where we went over the count policy again.
In an interview with the Executive Director of Surgical Services on 2/11/14 at 10:45am, the Executive Director states that there was a case of a sponge left in a patient which happened two weeks ago. The Executive Director of Surgical Services then states, the team in the room did not follow policy. The team never stuck the sponges in the Clear Counter machine (RFID machine) at the end of the surgery. They did 4 counts and they were all correct. Before the patient was extubated, we found the error. The patient was scanned with the RFID wand, a chest x-ray was done and the patient was brought back to surgery to remove the sponge.

2. Review of SP#2 medical records document that there were only 2 counts done for SP#2's surgical procedure. SP#2 medical records document that the patient was admitted the facility, on 02/03/14 for right knee surgery. The patient's medical record documents that the patient arrived to the OR on 02/03/14. The surgery ended at 4:10pm and the patient left the OR at 4:14pm. Review of the SP#2 medical records documents that the total number of sponge counts completed was 2.
3. Review of SP#3 medical records documents that there was only one count done during SP#3's surgical procedure. SP#3 medical records also reveals that the patient was admitted to the facility on 02/05/14 for surgery. Review of the patient's medical records shows the patient was taken to the OR on 02/10/14 at 2:46pm. Review of the patient's medical records shows that there was one surgical count documented in the patient's medical records.
In an interview with SE#4 on 02/14/14 at 1:10pm, the Circulating Registered Nurse (R.N.) states that the counts are done at least 3 times on every patient, even for minor surgeries.
In an interview with SE#8 on 02/11/14 at 10:59am, the Circulating RN states, that we do a minimum of 3 counts, before the first incision, as the first layer is being closed, and after sutures are made. If the count is incorrect, we stop, notify the doctor, and find the missing item. We use the Clear Count machine and we count manually.

In an interview with the Executive Director of Surgical Services on 02/14/14, it was reported that the surgical department has not been tracking errors with sponges. The Executive Director states, that since the purchase of the Radiofrequency Identification (RFID) in 2012, there have not been any incidences of retained sponges. Therefore, there is no need to track sponge counts.

Review of the facility's Sponge, Needle/Sharps and Instrument Counts policy documents that there will be at least 3 counts performed on all procedures: the first count prior to incision; the second count initiated just prior to closure of wound; the third count initiated after fascia is closed but before skin is closed. All counts are to be documented, individually and in the operative records to include, but not limited to name (s) and title (s) of O.R. personnel performing the count, results of surgical item counts, name (s) and title (s) of relief team members."
The Executive Director of Surgical Services also states that the improvement plan is to re-educate the staff on following the sponge and count policy.
During review of the retained sponge and Count Policy distribution attendance log (sign in sheets) it was noted, all of the OR staff (RNs and OR Techs) have not attended the sessions that were held on 01/30/14.
On 02/12/14 at 1:00pm, the Executive Director of Surgical Services reported, that the physicians that were involved in SP#1 incident have not been re-educated to date.

Based on observation, interview, and record review the facility failed to assume full responsibility to ensure that the quality assessment and improvement efforts address priorities for patient safety, and that all improvement actions are implemented and maintained in the resterilization of the Ortho/Neuro trays in the Central Sterile Storage Area.

Findings include:

Review of the report by the security department documents that on 01/31/14 there was a water leak in the 3rd floor surgical services storage room. The report states, there was a major water leak coming from the ceiling upon arrival. Plant ops (Operations) were on the scene replacing tiles and cleaning the area. The report further notes that the Assistant Director of Perioperative Services advised there was water damage to his supplies of surgical kits and drapes.
In an interview with SE#5 on 02/11/14 at 9:59am, the Central Service Tech states, I was here that day. The leak happened in the Ortho/Neuro trays storage. I went to the back of the Ortho/Neuro tray storage area to get a tray and I heard a dripping. I pushed the carts back and the whole area was leaking. We called Plant Ops, they came and everyone started moving stuff. Plant Ops repaired the leak. Our staff and the OR staff moved everything. Environmental Services cleaned up. We moved the trays and they sectioned off the area. The trays went to decontamination the same day. I did not have to clean up. The cleaning happened the same day.
In an interview with SE#6 on 02/11/14 at 10:04am, the Central Service Tech states, I was here when it happened. We got everything out the way as fast as we could. All the trays had to be redone. People came in to work overtime. I was asked to stay late to help move the trays. Some people came in on Saturday and worked all day. I didn't come in on Saturday. I came on Sunday. The majority of the trays were completed by the end of the weekend. All the trays went back to decontamination, were rewashed, and re-sterilized. I did not clean up. Environmental cleaned up the spill. I took the trays to be redone. I don't know exactly what was coming down, it was amber colored. There was no smell to tell if it was urine. It was not feces. They threw away a lot of supplies.

During an observation of the Central Sterile Storage on 02/11/14 at 09:45 am reveals, a clean storage area and a sterile storage area. The Sterile storage area consists of racks with trays which included Ortho/Neurology (neuro), General Thoracic, Vascular, Otolaryngology, Plastic, and Oral-maxillofacial trays.
Another observation of the Ortho/Neurology racks on 02/14/14 at 2:20 pm reveals, that there are trays with sterilization stickers that were dated December 31, 2012 (on rack 3), January 9, 2013 (on rack 3), October 4, 2013, October 5, 2013, January 14, 2013, January 20, 2013 (on rack 3), and January 31, 2014. It was noted these trays were dated prior to and on the date of the ceiling leak.
In an interview with the Central Sterile Room (CSR) Manager on 02/11/14 at 9:51am, the manager states that there was a leak in the Central Sterile Supply room two weeks ago on Friday January 31, 2014 and that the Ortho and Neuro trays were affected. The manager states the trays were rewrapped and went through decontamination with an enzymatic solution. The Central Sterile staff took the trays to the decontamination room. The leak came from the 4th floor. The sink in the bathroom was stopped up and overflowed. The ceiling tiles were replaced and the leak was cleaned up in one day. Seventeen (17) carts (also called racks) were affected, 15 were moved because 2 are permanently bolted to the floor. The things that were wet were decontaminated.
In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 10:14am, the Administration personnel states, there is a sink upstairs, the faucets were left on, the water overflowed and floated down. The whole Ortho/Neurology area was contained. We placed a big plastic cover to cover the ceiling. The ceiling was sprayed with a bacterial cleaner mist before we put the plastic. The tiles in the ceiling were replaced. Everything took 2 to 3 hours to repair. The racks that got wet were re-sterilized. 3 racks got wet.
On 02/11/14 at 1:07pm, observation was made of the bathroom in the Medical Information System (MIS) Training Room (#4104) on the fourth floor where the leak started.
In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 1:07pm it was reported, that the facility plans to change the water faucets to hands-free motion detected water faucets. This way the water cannot be left running.
In an interview with the Executive Director of Surgical Services on 02/12/14 at 1:03pm, the Executive Director states that there is no tray tracking system to track which trays were on the racks before the leak.
In an interview with the Executive Director of Infection Control on 02/11/14 at 10:26am, the Executive Director of Infection Control states, I was made aware of the leak when it happened. I am not following the trays that are being used after the leak because all the trays were decontaminated to my knowledge.
Review of the Infection Control Program policy and procedure has that the objective is to: (7) create a safe environment and identify infection control risks, and (10) establish a system to determine if action is taken when necessary, if problem are resolved, and improvement noted.

Based upon record review, interview and observation, the facility failed to ensure the Surgical Services Department achieves and maintains a high standard of medical practice and patient care by ensuring: 1) The surgical sponge counts are conducted according to the facility's policy in 3 out of 12 sampled patients (SP) #1, #2 and #3) and 2) The re-sterilization of the Orthro/ Neuro trays in the Central Sterile Storage area.

The Finding include:

1. Sampled Patient (SP#1) was admitted to the facility on 01/27/14. Review of the patient's medical record reveals that the 1st surgery (coronary artery bypass) started at 9:01am and ended at 1:15pm. The patient left the OR (Operating Room) and was transferred to the CCU (Critical Care Unit). Further review of the Surgical Case Record documents that there was 3 surgical counts conducted during the surgery. The count included instruments, laps (sponges), blades, needles, booties, and misc. (miscellaneous). The Nurse's Notes on 01/28/14 document that the patient was received in CCU and was transferred back to the OR (Operating Room) by the OR team for a foreign body removal. The Surgical Case Record for the chest re-exploration (second surgery) documents that the patient arrived backed to the OR room at 3:23pm for the chest re-exploration. The Operative Report, dictated by the surgeon, on 01/28/14 has that a re-exploration and removal of a lap pad was performed. The Operative Note also states, the patient underwent an uneventful coronary artery bypass earlier today. The results of his chest x-ray revealed, the patient was found to have a retained lap pad and he was brought to the operating room presently for removal.
SP#1 patient ' s medical records show that there were 3 Circulating Registered Nurses (RN) and 2 Surgical Techs for the CABG surgery on 01/28/14. Sampled Employee (SE) #1 & #3 were Circulating Nurses and SE#2 was one of the Surgical Techs for SP#1.
In an interview with sampled employee (SE) #1 on 02/12/14 at 3:14pm, the Circulating RN states, I was relieving [name of SE#3] for lunch. We counted. I thought I had the correct count. [Name of SE#3] was the Circulating Nurse. I came at 12pm. I looked on the board to see the count before. I discovered when I got there that the count was wrong. There were initially 40 laps and there were only 39. We searched and looked for the lap. There were 9 on the table and 30 in the bags. I counted three times. I looked around for the one. I rang them into the machine 3 times and on the 4th count, there was a lap in the bucket in the Clear Count Machine. It appeared in the clear count bucket. I didn't put it in the bucket. I thought the scrub tech threw it there. It just appeared there. I counted again and it was 40. I assumed the lap fell out of the bucket and someone put it back in the bucket. [Name of SE#3] came back from lunch, saw it was 40 and I moved on. I came back to the room after the surgery to clear the count and saw that it was not correct. It was saying 39 (thirty-nine). I had held up the surgery because of the miscount. I couldn't find the lap. I dreaded it ended up in a patient. I went to scan the patient with the wand and brought the patient back.
In an interview with SE#3 on 02/12/14 at 3:35pm, the Circulating RN states, I was gone to lunch, when I came back from lunch, I was told that we were missing a sponge. We started looking, we couldn't find a sponge. We counted the field, there were 9. [Name of SE#1] had one in his hands from the bucket. We counted the field again. One was in the bucket, and 30(thirty) off the field. We thought we had the correct count at the time. I did not open the bags to see what was in each of the 3 bags. This was the final count. We left the room, later we realized we left the sponge. I did not clear the Clear Count. To clear the Clear Count machine, we put everything in the bucket. That was not done prior to the patient leaving. I forgot to check the Clear Count Machine. After the incident, we had meetings, completed an analysis, and we had meeting where we went over the count policy again.
In an interview with the Executive Director of Surgical Services on 2/11/14 at 10:45am, the Executive Director states that there was a case of a sponge left in a patient which happened two weeks ago. The Executive Director of Surgical Services then states, the team in the room did not follow policy. The team never stuck the sponges in the Clear Counter machine (RFID machine) at the end of the surgery. They did 4 counts and they were all correct. Before the patient was extubated, we found the error. The patient was scanned with the RFID wand, a chest x-ray was done and the patient was brought back to surgery to remove the sponge.

2. Review of SP#2 medical records document that there were only 2 counts done for SP#2's surgical procedure. SP#2 medical records document that the patient was admitted the facility, on 02/03/14 for right knee surgery. The patient's medical record documents that the patient arrived to the OR on 02/03/14. The surgery ended at 4:10pm and the patient left the OR at 4:14pm. Review of the SP#2 medical records documents that the total number of sponge counts completed was 2.
3. Review of SP#3 medical records documents that there was only one count done during SP#3's surgical procedure. SP#3 medical records also reveals that the patient was admitted to the facility on 02/05/14 for surgery. Review of the patient's medical records shows the patient was taken to the OR on 02/10/14 at 2:46pm. Review of the patient's medical records shows that there was one surgical count documented in the patient's medical records.
In an interview with SE#4 on 02/14/14 at 1:10pm, the Circulating Registered Nurse (R.N.) states that the counts are done at least 3 times on every patient, even for minor surgeries.
In an interview with SE#8 on 02/11/14 at 10:59am, the Circulating RN states, that we do a minimum of 3 counts, before the first incision, as the first layer is being closed, and after sutures are made. If the count is incorrect, we stop, notify the doctor, and find the missing item. We use the Clear Count machine and we count manually.

In an interview with the Executive Director of Surgical Services on 02/14/14, it was reported that the surgical department has not been tracking errors with sponges. The Executive Director states, that since the purchase of the Radiofrequency Identification (RFID) in 2012, there have not been any incidences of retained sponges. Therefore, there is no need to track sponge counts.

Review of the facility's Sponge, Needle/Sharps and Instrument Counts policy documents that there will be at least 3 counts performed on all procedures: the first count prior to incision; the second count initiated just prior to closure of wound; the third count initiated after fascia is closed but before skin is closed. All counts are to be documented, individually and in the operative records to include, but not limited to name (s) and title (s) of O.R. personnel performing the count, results of surgical item counts, name (s) and title (s) of relief team members."
The Executive Director of Surgical Services also states that the improvement plan is to re-educate the staff on following the sponge and count policy.
During review of the retained sponge and Count Policy distribution attendance log (sign in sheets) it was noted, all of the OR staff (RNs and OR Techs) have not attended the sessions that were held on 01/30/14.
On 02/12/14 at 1:00pm, the Executive Director of Surgical Services reported, that the physicians that were involved in SP#1 incident have not been re-educated to date.

4. Review of the report by the security department documents that on 01/31/14 there was a water leak in the 3rd floor surgical services storage room. The report states, there was a major water leak coming from the ceiling upon arrival. Plant ops (Operations) were on the scene replacing tiles and cleaning the area. The report further notes that the Assistant Director of Perioperative Services advised there was water damage to his supplies of surgical kits and drapes.
In an interview with SE#5 on 02/11/14 at 9:59am, the Central Service Tech states, I was here that day. The leak happened in the Ortho/Neuro trays storage. I went to the back of the Ortho/Neuro tray storage area to get a tray and I heard a dripping. I pushed the carts back and the whole area was leaking. We called Plant Ops, they came and everyone started moving stuff. Plant Ops repaired the leak. Our staff and the OR staff moved everything. Environmental Services cleaned up. We moved the trays and they sectioned off the area. The trays went to decontamination the same day. I did not have to clean up. The cleaning happened the same day.
In an interview with SE#6 on 02/11/14 at 10:04am, the Central Service Tech states, I was here when it happened. We got everything out the way as fast as we could. All the trays had to be redone. People came in to work overtime. I was asked to stay late to help move the trays. Some people came in on Saturday and worked all day. I didn't come in on Saturday. I came on Sunday. The majority of the trays were completed by the end of the weekend. All the trays went back to decontamination, were rewashed, and re-sterilized. I did not clean up. Environmental cleaned up the spill. I took the trays to be redone. I don't know exactly what was coming down, it was amber colored. There was no smell to tell if it was urine. It was not feces. They threw away a lot of supplies.

During an observation of the Central Sterile Storage on 02/11/14 at 09:45 am reveals, a clean storage area and a sterile storage area. The Sterile storage area consists of racks with trays which included Ortho/Neurology (neuro), General Thoracic, Vascular, Otolaryngology, Plastic, and Oral-maxillofacial trays.
Another observation of the Ortho/Neurology racks on 02/14/14 at 2:20 pm reveals, that there are trays with sterilization stickers that were dated December 31, 2012 (on rack 3), January 9, 2013 (on rack 3), October 4, 2013, October 5, 2013, January 14, 2013, January 20, 2013 (on rack 3), and January 31, 2014. It was noted these trays were dated prior to and on the date of the ceiling leak.
In an interview with the Central Sterile Room (CSR) Manager on 02/11/14 at 9:51am, the manager states that there was a leak in the Central Sterile Supply room two weeks ago on Friday January 31, 2014 and that the Ortho and Neuro trays were affected. The manager states the trays were rewrapped and went through decontamination with an enzymatic solution. The Central Sterile staff took the trays to the decontamination room. The leak came from the 4th floor. The sink in the bathroom was stopped up and overflowed. The ceiling tiles were replaced and the leak was cleaned up in one day. Seventeen (17) carts (also called racks) were affected, 15 were moved because 2 are permanently bolted to the floor. The things that were wet were decontaminated.
In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 10:14am, the Administration personnel states, there is a sink upstairs, the faucets were left on, the water overflowed and floated down. The whole Ortho/Neurology area was contained. We placed a big plastic cover to cover the ceiling. The ceiling was sprayed with a bacterial cleaner mist before we put the plastic. The tiles in the ceiling were replaced. Everything took 2 to 3 hours to repair. The racks that got wet were re-sterilized. 3 racks got wet.
On 02/11/14 at 1:07pm, observation was made of the bathroom in the Medical Information System (MIS) Training Room (#4104) on the fourth floor where the leak started.
In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 1:07pm it was reported, that the facility plans to change the water faucets to hands-free motion detected water faucets. This way the water cannot be left running.
In an interview with the Executive Director of Surgical Services on 02/12/14 at 1:03pm, the Executive Director states that there is no tray tracking system to track which trays were on the racks before the leak.
In an interview with the Executive Director of Infection Control on 02/11/14 at 10:26am, the Executive Director of Infection Control states, I was made aware of the leak when it happened. I am not following the trays that are being used after the leak because all the trays were decontaminated to my knowledge.
Review of the Infection Control Program policy and procedure has that the objective is to: (7) create a safe environment and identify infection control risks, and (10) establish a system to determine if action is taken when necessary, if problem are resolved, and improvement noted.

Based upon interviews and record reviews, the facility failed to ensure that surgical consents were obtained according to the facility's policy in 4 out of 12 sampled patients (SP) #1, #8, #11 and #12.

The findings include:

Review of the facility's Legal Authorization for Treatment Consent documents in Section D: that all consent forms shall be signed in English by the person obtaining the consent, the interpreter if the consent is explained in a non-English language, the patient and the witness. Spanish versions may be offered to the patient for reference only. No signature is required on the Spanish version; this is informational only.

Section D also documents that the patient shall sign, date and time the consent form. The witness shall observe the signature and then sign, date and time in the space provided for the witness on the consent form. By this signature, the witness is indicating only that s/he observed the patient sign the consent form.

Section H documents that in the event of a medical emergency, the operation/procedure may be performed without first obtaining informed consent and In lieu of written evidence of consent, the declaration of a medical emergency should be made in the progress notes with the reasons for the incapacity, by the two (2) physicians, with the date and time that the note was written. Both physicians should also sign the surgical consent form.

1. Sampled Patient (SP#1) was admitted to the facility on 01/27/14. Review of the patient's medical record reveals that the 1st surgery (coronary artery bypass) started at 9:01am and ended at 1:15pm. The patient left the OR (Operating Room) and was transferred to the CCU (Critical Care Unit). The Nurse's Notes on 01/28/14 document that the patient was received in CCU and was transferred back to the OR (Operating Room) by the OR team for a foreign body removal. The Operative Report, dictated by the surgeon, on 01/28/14 documents that a re-exploration and removal of a lap pad was performed.
Sampled patient #1's medical record did not include a surgical consent for the chest re-exploration.
During an interview with the Executive Director of Surgical Services on 02/14/14 at 9:30am, the Executive Director states that SP#1 second surgery was an emergency surgery and no consent was signed. At 1:15pm on 02/14/14, the Executive Director states that in emergencies, if consent cannot be obtained, the physician can obtain two signatures from different physicians.

In an interview with SE#4 on 02/14/14 at 1:10pm, the Circulating Registered Nurse (RN) reported, all patients need to consent before surgery. In emergencies, we contact the next of kin, if the person doesn't answer, two surgeons need to be aware and consent. Emergency surgeries will be scheduled on the roster by the surgeon.

2. Sampled Patient (SP#8) medical record show that the patient was admitted to the facility on 01/31/14 . The patient ' s medical record shows that on 02/09/14, the patient underwent pacer surgery. Review of the patient's medical records show that a Spanish surgical consent for " insercion de marcapaso permanente venografia con contraste de yodo " was signed by the patient, a witness, and the physician. There was no signed English version of the surgical consent in the record.

3. Sampled Patient (SP#11) medical record reveals that the patient was admitted to the facility on 02/11/14 for an elective surgical procedure. Review of the surgical consent form reveals one signature, which the Executive Director of Regulatory Compliance Officer on 02/14/14, identified as the witness's signature. The consent was also signed and dated 02/11/14, by the physician. The patient's signature was not on the surgical consent and there was no date where the witness signed. Review of the Operative Note reveals the date of operation was 02/11/14.

4. Review of Sampled Patient (SP#12) medical record shows that the patient underwent hip surgery on 02/11/14. Review of the patient's medical records shows a Spanish surgical consent that was signed by the patient, a witness, and the physician on 02/11/14. There was no signed English version of the surgical consent in the record.

Based upon observation, interview, and record review, the facility failed to ensure that the infection control program be responsible for the implementation of a successful corrective action plan in an area where a ceiling leak occurred, the Ortho/Neurology trays located in the Central Sterile Storage area had to re-sterilized.

The findings include:

Review of the report by the security department documents that on 01/31/14 there was a water leak in the 3rd floor surgical services storage room. The report states, there was a major water leak coming from the ceiling upon arrival. Plant ops (Operations) were on the scene replacing tiles and cleaning the area. The report further notes that the Assistant Director of Perioperative Services advised there was water damage to his supplies of surgical kits and drapes.

In an interview with SE#5 on 02/11/14 at 9:59am, the Central Service Tech states, I was here that day. The leak happened in the Ortho/Neuro trays storage. I went to the back of the Ortho/Neuro tray storage area to get a tray and I heard a dripping. I pushed the carts back and the whole area was leaking. We called Plant Ops, they came and everyone started moving stuff. Plant Ops repaired the leak. Our staff and the OR staff moved everything. Environmental Services cleaned up. We moved the trays and they sectioned off the area. The trays went to decontamination the same day. I did not have to clean up. The cleaning happened the same day.
In an interview with SE#6 on 02/11/14 at 10:04am, the Central Service Tech states, I was here when it happened. We got everything out the way as fast as we could. All the trays had to be redone. People came in to work overtime. I was asked to stay late to help move the trays. Some people came in on Saturday and worked all day. I didn't come in on Saturday. I came on Sunday. The majority of the trays were completed by the end of the weekend. All the trays went back to decontamination, were rewashed, and re-sterilized. I did not clean up. Environmental cleaned up the spill. I took the trays to be redone. I don't know exactly what was coming down, it was amber colored. There was no smell to tell if it was urine. It was not feces. They threw away a lot of supplies.

During an observation of the Central Sterile Storage on 02/11/14 at 09:45 am reveals, a clean storage area and a sterile storage area. The Sterile storage area consists of racks with trays which included Ortho/Neurology (neuro), General Thoracic, Vascular, Otolaryngology, Plastic, and Oral-maxillofacial trays.
Another observation of the Ortho/Neurology racks on 02/14/14 at 2:20 pm reveals, that there are trays with sterilization stickers that were dated December 31, 2012 (on rack 3), January 9, 2013 (on rack 3), October 4, 2013, October 5, 2013, January 14, 2013, January 20, 2013 (on rack 3), and January 31, 2014. It was noted these trays were dated prior to and on the date of the ceiling leak.

In an interview with the Central Sterile Room (CSR) Manager on 02/11/14 at 9:51am, the manager states that there was a leak in the Central Sterile Supply room two weeks ago on Friday January 31, 2014 and that the Ortho and Neuro trays were affected. The manager states the trays were rewrapped and went through decontamination with an enzymatic solution. The Central Sterile staff took the trays to the decontamination room. The leak came from the 4th floor. The sink in the bathroom was stopped up and overflowed. The ceiling tiles were replaced and the leak was cleaned up in one day. Seventeen (17) carts (also called racks) were affected, 15 were moved because 2 are permanently bolted to the floor. The things that were wet were decontaminated.
In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 10:14am, the Administration personnel states, there is a sink upstairs, the faucets were left on, the water overflowed and floated down. The whole Ortho/Neurology area was contained. We placed a big plastic cover to cover the ceiling. The ceiling was sprayed with a bacterial cleaner mist before we put the plastic. The tiles in the ceiling were replaced. Everything took 2 to 3 hours to repair. The racks that got wet were re-sterilized. 3 racks got wet.

On 02/11/14 at 1:07pm, observation was made of the bathroom in the Medical Information System (MIS) Training Room (#4104) on the fourth floor where the leak started.

In an interview with the Operation Plant and Environmental Administration on 02/11/14 at 1:07pm it was reported, that the facility plans to change the water faucets to hands-free motion detected water faucets. This way the water cannot be left running.
In an interview with the Executive Director of Surgical Services on 02/12/14 at 1:03pm, the Executive Director states that there is no tray tracking system to track which trays were on the racks before the leak.
In an interview with the Executive Director of Infection Control on 02/11/14 at 10:26am, the Executive Director of Infection Control states, I was made aware of the leak when it happened. I am not following the trays that are being used after the leak because all the trays were decontaminated to my knowledge.

Review of the Infection Control Program policy and procedure has that the objective is to: (7) create a safe environment and identify infection control risks, and (10) establish a system to determine if action is taken when necessary, if problem are resolved, and improvement noted.