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Based on review of documentation, interviews with involved clinical staff and interview with the Risk Manager, the Hospital failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyzed the cause and preventive actions and mechanisms that included feedback and learning throughout the hospital were implemented. At the time of the survey, 4/28/11, the cause of the incorrect sponge count was not identified, even though correct counts (initial and final) were recorded on the operative record. However, interviews with clinical staff involved in the case identified several causal factors that could have resulted in human error resulting in a miscount/retained surgical sponge.

Background information:

The Hospital reported a retained surgical sponge regarding an operative case on 4/11/11 in which a laparoscopic cholecystectomy [gallbladder removal] converted to an open gastric bypass procedure. At the conclusion of the case, the final count was documented as correct. On 4/12/11, during a routine swallow study, the radiologic image demonstrated a retained surgical sponge. Patient #1 underwent an exploratory laparotomy for removal of a laparotomy pad.

Findings included:

1) The Primary Circulating/Scrub Nurse was interviewed in person on 4/28/11 at 8:40 am. The Primary Circulating/Scrub Nurse [PCS] Nurse said she was precepting another nurse for the circulating nurse role. The PCS Nurse said the case began as a laparoscopic incision [several small incisions are made for insertion of scopes for visualization and operative maneuvering] for removal of the gallbladder.

The PCS Nurse said that operative instrumentation is different for laparoscopic procedures than for "open" surgical procedures where the abdominal skin is cut several inches and the body cavity opened for the surgical procedure. The PCS said different instrument kits are required for each type of surgical procedure and there are a "lot of instruments" to open one by one and count to get a case started.

The PCS Nurse said that during the laparoscopic removal of the gallbladder, a "bleeder" [a bleeding vessel] was noted and the Surgeon wanted to open Patient #1's abdomen right away to identify and stop the source of bleeding. The PCS said there was an atmosphere of "urgency" and the PCS said she asked the Surgeon to stop because an additional count of the new instrumentation kit [open] needed to be performed. The PCS said the Surgeon did stop for the count, but reiterated that he needed to move on as soon as possible due to concerns about the source of bleeding. The PCS said there was another nurse in the role of learning the circulating nurse role in the operating room [OR]. The PCS said she instructed that nurse to start the count with the Scrub Nurse while she left the room to obtain more surgical instrumentation kits needs for the conversion to an open surgical case. The PCS said she was not present for the initial count. The PCS said the Surgeon needed to rush them to ready the needed instruments/ surgical equipment, so the nurses were opening the kits hurriedly. The PCS said she "decided to scrub in at that point to speed up the process." The PCS said that the first set of sponges and laparotomy sponges were counted. The PCS said that a huge incision had been made on the abdomen. The PCS said that all the laparoscopic instruments were taken off the field and placed in one corner of the OR. The PCS said that when all the additional kits brought to the room were counted, she scrubbed out of the case. The PCS said there "was a rush in doing all those things." The PCS said the bleeder was large and a lot of laparotomy sponges were needed. The PCS said that additional laparotomy sponge packages were opened and counted. The PCS said she instructed the Circulating Nurse Oriented [CNO] to take all the laparotomy sponges off the field and put them in the kick bucket where they would be taken out and counted one by one. The PCS said the CNO counted and bagged the sponges with the Scrub Nurse. The CNO left at 5 pm.

The PCS said it is her personal clinical practice to limit the amount of laparoscopic pads and not let them accumulate to higher numbers. The PCS said she never allows more than 10 laparoscopic pad [or two packs] in the field. The PCS said that the circulating nurse orientee and the scrub nurse conducted the first/initial count and she was not paying attention because she was getting additional surgical kits for the open surgical procedure.

The PCS said she was sure of the final count because what she could physically see - gets counted. The sponges were visualized, counted and bagged - and that count was correct as well.

The PCS said there were several factors that may have contributed to the retained sponge: 1) there may have been more sponges in a factory prepared package, which are provided in packages of 5. [The statistics for an incorrect amount of sponges placed in a package from the factory is 1:10,000]. 2) There was a sense of urgency/rush based on the identification of a bleeder and the decision to change from a laparoscopic to open surgical procedure. 3) The PCS said her attention was divided. The PCS was in and out of the operating room several times to obtain additional surgical kits and materials.


2) The CNO was interviewed in person on 4/28/11 at 10:40 am. The CNO said she was employed at the hospital for three years as an operating room nurse, but on the other campus which did different cases, such as minor ambulatory and orthopedic cases. The CNO said that bariatric cases were completely new to her. The CNO said this case was only her second bariatric case and each Surgeon was different. The CNO said she was still on orientation with the PCS.

The CNO said she arrived at 3 pm and at that point, the laparoscopic instrumentation set was being removed. The CNO said the PCS scrubbed in to assist in this process and helped her complete this task. The CNO said she and the Scrub counted all the open instrument sets. The CNO said they asked the Surgeon if they could have extra time to count the additional instruments for the open surgical procedure and the Surgeon agreed, but said the patient was bleeding and they needed to hurry.

The CNO said Patient #1's gall bladder was removed during the laparoscopy procedure and the open procedure was started for the gastric bypass procedure. The CNO said there was a commotion at 3 pm because it was change of shift. The CNO said the Surgeon was upset because it was not a good time for the changeover of staff. The CNO said the Surgeon told them if you have to leave the room, tell me.

At this point, there were the CNO, the PCS and Scrub Technician present during the conversion from laparoscopic to open procedure. The CNO said the PCS left the room several times to get additional surgical instrument sets. The CNO said she counted with the Scrub Technician and they proceeded with an open surgical gastric bypass.

The CNO said she bagged two sets of 5 laparoscopic sponges with the Scrub Technician. The CNO said she left at 5 pm. The CNO was not present for the final count.

The PCS and the Scrub Technician performed the final count.

3) It should be noted that the PCS was previously precepting another Scrub Technician and there was another Circulating Nurse precepting the CNO. In total, there were two Scrub Technicians and two Circulating Nurses on the case. There were a total of six OR staff for the procedure. One Scrub Technician and one Circulating Nurse left at 3 pm for change of shift.

4) The Scrub Technician was interviewed in person on 4/28/11 at 11:50 am. The Scrub Technician [ST] said she arrived at 3 pm to relieve the first Scrub Technician. The ST said she arrived at the end of the laparoscopic procedure when the gall bladder was being removed. The ST said the PCS relieved the Circulating Nurse who was orienting the CNO. The ST said there was a lot of instruments that needed to be counted and moved out from the laparoscopic procedure and a new kit needed to be brought into the room for the open procedure.

The ST said she recalled the Surgeon gave them about 2 minutes to perform the counts for taking off the laparoscopic instruments and opening the surgical instruments for the open procedure. The ST said there was urgency based on the bleeding noted.

The ST said the PCS was not in the room at the time of the counts because she was obtaining the extra surgical kits for the open procedure. The ST said the PCs was in and out of the room several times. The ST said that she and the CNO performed the count on the sterile field. At one point the PCS scrubbed in to help and then scrubbed out to resume the role as Primary Circulating Nurse and continue orienting the new Circulating Nurse.

The ST said she and the PCS conducted the final count of the laparoscopic sponges. The ST said they reported the count as correct to the Surgeon and it was repeated again. The counts were conducted according to policy and they were correct. The ST said they were informed the following day of the retained laparoscopic sponge.

The ST said there were several factors in this case: 1) there was a sense of urgency, so they were rushing and that does not help 2) the case changed from an expected closed or laparoscopic procedure to an open abdomen case for the gastric bypass. 3) "There were three sets of hands in the pot" during the counting process. The ST said the PCS and the CNO counted and bagged a different set of laparotomy sponges. The CNO then left at 5 pm. The ST said that the PCS and she did a final laparotomy sponge count and it was correct.

5) Review of the Pre-operative Record dated 4/11/11 indicated that there were six clinicians present for the case: 3 Scrub Technicians: different scrubs began the case and ended the case. The PCS also served as a scrub technician for a period of time. There was a scrub orientee at the beginning of the case who left at 3 pm. The Circulating Primary Nurse was assigned to the Circulating Nurse Orientee. There was also an additional Circulating Nurse at the beginning of the case and left at 3 pm.

6) Review of the Operative Record indicated the initial and final instrument and sponge counts were correct.

7) Review of the Hospital Policy titled Prevention of Unintentionally Retained Objects, section II Policy Statements, A, 3. indicated the initial count establishes the baseline for subsequent counts.

B. Active communication between all members of the surgical team must be employed in the count process, which includes verbal notification of the status of all counts when executed.

C. To ensure patient safety, distractions must be avoided during the count process.
1. Time must be allowed for the focused performance of counts to ensure accuracy.
2. Nonessential task must be minimized.
3. Hand-offs should not occur while actively counting.

D. An exploration of the operative site should be performed by the Surgeon before the closure.

Based on review of documentation, interviews with clinical staff and the Risk Manager, the Hospital failed to ensure the Hospital took actions aimed at performance improvement. Although the initial and final counts were documented as correct, a retained surgical sponge was identified on x-ray the day following surgery. As of the day of the survey, 4/28/11, the Hospital had not implemented any plans to safeguard patients against having such an event occur.

1) The Perioperative Nurse Manager and the Perioperative Nurse Specialist were interviewed in person on 4/28/11 at 2:20 pm. They said there is a special Quality Assurance Topic for near misses. They said a Graduate Student is working with them. They said the standard incident reporting system does not capture relevant data in this situation. They said they are currently inquiring what other Hospitals are doing in this situation and conducting a literature search. They said there was an initial meeting the day of the incident with most of the involved staff. The case was also discussed at the weekly safety meeting with chiefs the prior day. They said they are "still digging down" to identify the cause of the error/documentation of correct count, but with the outcome of a retained sponge. They said there is no resolution at this time. They said they do not want to rush on the analysis.

They said the Hospital had formed a Safety Culture Task Force in which any member of the clinical team could call a time out or huddle to discuss concerns/issues in a case. The PCS is a member of this task force and is a 24 year employee of the Hospital with long term OR experience.

During interview, the clinicians identified several factors which contributed to confusion and rush during the count procedures, yet none of the team members considered calling a time out prior to Patient #1 leaving the OR for a final x-ray.

2) The Risk Manager was interviewed in person on 4/28/11 at 1:50 pm. The Risk Manager [RM] said the Root Cause Analysis was protected peer information and was not shared with this Surveyor. The RM said the analysis was not complete and stressed the Hospital had 30 days to complete the analysis. The RM said the plan of correction was also not completed. The RM said that calls were made to other Hospitals for copies of their policies and they would be reviewed. At the time of the survey, there was no plan implemented to protect patients from having this type of incident/error occur again.

Based on review of documentation and interviews, the Hospital failed to ensure that surgical services were consistent with needs and resources. The Hospital failed to ensure that surgical services policies governing surgical care were designed to assure the achievement and maintenance of high standards of medical practice and patient care.

Findings included:

1) Although the Hospital had implemented a Safety Culture Task Force in which any member of the clinical team could call a time out or huddle to discuss concerns/issues in a case, and the PCS is a member of the task force, no member of the surgical team considered calling a time out in this case.

2) Review of the medical record and interviews indicated that despite several factors that could contribute to a human error in counting: 1) conversion from laparoscopic to open 2) identification of a bleeding vessel 3) a rush/emergent situation with limited time allotted by the Surgeon to count the outgoing laparoscopic instruments and the incoming open surgical instruments 4) the addition of additionally sponges to contain/control the bleeding source and 5) change of shift with outgoing/incoming staff - compounded with 2 additional orientee 6) distractions 7) the circulating nurse leaving and entering the OR several times to obtain extra surgical kids, no member of the team considered calling a time out to perform an additional count or to consider obtaining a final x-ray.

3) There were no revisions in the Prevention of Unintentionally retained Objects Policy as a result of this incident.

Based on review of documentation, interviews with involved clinical staff and interview with the Risk Manager, the Hospital failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyzed the cause and preventive actions and mechanisms that included feedback and learning throughout the hospital were implemented. At the time of the survey, 4/28/11, the cause of the incorrect sponge count was not identified, even though correct counts (initial and final) were recorded on the operative record. However, interviews with clinical staff involved in the case identified several causal factors that could have resulted in human error resulting in a miscount/retained surgical sponge.

Background information:

The Hospital reported a retained surgical sponge regarding an operative case on 4/11/11 in which a laparoscopic cholecystectomy [gallbladder removal] converted to an open gastric bypass procedure. At the conclusion of the case, the final count was documented as correct. On 4/12/11, during a routine swallow study, the radiologic image demonstrated a retained surgical sponge. Patient #1 underwent an exploratory laparotomy for removal of a laparotomy pad.

Findings included:

1) The Primary Circulating/Scrub Nurse was interviewed in person on 4/28/11 at 8:40 am. The Primary Circulating/Scrub Nurse [PCS] Nurse said she was precepting another nurse for the circulating nurse role. The PCS Nurse said the case began as a laparoscopic incision [several small incisions are made for insertion of scopes for visualization and operative maneuvering] for removal of the gallbladder.

The PCS Nurse said that operative instrumentation is different for laparoscopic procedures than for "open" surgical procedures where the abdominal skin is cut several inches and the body cavity opened for the surgical procedure. The PCS said different instrument kits are required for each type of surgical procedure and there are a "lot of instruments" to open one by one and count to get a case started.

The PCS Nurse said that during the laparoscopic removal of the gallbladder, a "bleeder" [a bleeding vessel] was noted and the Surgeon wanted to open Patient #1's abdomen right away to identify and stop the source of bleeding. The PCS said there was an atmosphere of "urgency" and the PCS said she asked the Surgeon to stop because an additional count of the new instrumentation kit [open] needed to be performed. The PCS said the Surgeon did stop for the count, but reiterated that he needed to move on as soon as possible due to concerns about the source of bleeding. The PCS said there was another nurse in the role of learning the circulating nurse role in the operating room [OR]. The PCS said she instructed that nurse to start the count with the Scrub Nurse while she left the room to obtain more surgical instrumentation kits needs for the conversion to an open surgical case. The PCS said she was not present for the initial count. The PCS said the Surgeon needed to rush them to ready the needed instruments/ surgical equipment, so the nurses were opening the kits hurriedly. The PCS said she "decided to scrub in at that point to speed up the process." The PCS said that the first set of sponges and laparotomy sponges were counted. The PCS said that a huge incision had been made on the abdomen. The PCS said that all the laparoscopic instruments were taken off the field and placed in one corner of the OR. The PCS said that when all the additional kits brought to the room were counted, she scrubbed out of the case. The PCS said there "was a rush in doing all those things." The PCS said the bleeder was large and a lot of laparotomy sponges were needed. The PCS said that additional laparotomy sponge packages were opened and counted. The PCS said she instructed the Circulating Nurse Oriented [CNO] to take all the laparotomy sponges off the field and put them in the kick bucket where they would be taken out and counted one by one. The PCS said the CNO counted and bagged the sponges with the Scrub Nurse. The CNO left at 5 pm.

The PCS said it is her personal clinical practice to limit the amount of laparoscopic pads and not let them accumulate to higher numbers. The PCS said she never allows more than 10 laparoscopic pad [or two packs] in the field. The PCS said that the circulating nurse orientee and the scrub nurse conducted the first/initial count and she was not paying attention because she was getting additional surgical kits for the open surgical procedure.

The PCS said she was sure of the final count because what she could physically see - gets counted. The sponges were visualized, counted and bagged - and that count was correct as well.

The PCS said there were several factors that may have contributed to the retained sponge: 1) there may have been more sponges in a factory prepared package, which are provided in packages of 5. [The statistics for an incorrect amount of sponges placed in a package from the factory is 1:10,000]. 2) There was a sense of urgency/rush based on the identification of a bleeder and the decision to change from a laparoscopic to open surgical procedure. 3) The PCS said her attention was divided. The PCS was in and out of the operating room several times to obtain additional surgical kits and materials.


2) The CNO was interviewed in person on 4/28/11 at 10:40 am. The CNO said she was employed at the hospital for three years as an operating room nurse, but on the other campus which did different cases, such as minor ambulatory and orthopedic cases. The CNO said that bariatric cases were completely new to her. The CNO said this case was only her second bariatric case and each Surgeon was different. The CNO said she was still on orientation with the PCS.

The CNO said she arrived at 3 pm and at that point, the laparoscopic instrumentation set was being removed. The CNO said the PCS scrubbed in to assist in this process and helped her complete this task. The CNO said she and the Scrub counted all the open instrument sets. The CNO said they asked the Surgeon if they could have extra time to count the additional instruments for the open surgical procedure and the Surgeon agreed, but said the patient was bleeding and they needed to hurry.

The CNO said Patient #1's gall bladder was removed during the laparoscopy procedure and the open procedure was started for the gastric bypass procedure. The CNO said there was a commotion at 3 pm because it was change of shift. The CNO said the Surgeon was upset because it was not a good time for the changeover of staff. The CNO said the Surgeon told them if you have to leave the room, tell me.

At this point, there were the CNO, the PCS and Scrub Technician present during the conversion from laparoscopic to open procedure. The CNO said the PCS left the room several times to get additional surgical instrument sets. The CNO said she counted with the Scrub Technician and they proceeded with an open surgical gastric bypass.

The CNO said she bagged two sets of 5 laparoscopic sponges with the Scrub Technician. The CNO said she left at 5 pm. The CNO was not present for the final count.

The PCS and the Scrub Technician performed the final count.

3) It should be noted that the PCS was previously precepting another Scrub Technician and there was another Circulating Nurse precepting the CNO. In total, there were two Scrub Technicians and two Circulating Nurses on the case. There were a total of six OR staff for the procedure. One Scrub Technician and one Circulating Nurse left at 3 pm for change of shift.

4) The Scrub Technician was interviewed in person on 4/28/11 at 11:50 am. The Scrub Technician [ST] said she arrived at 3 pm to relieve the first Scrub Technician. The ST said she arrived at the end of the laparoscopic procedure when the gall bladder was being removed. The ST said the PCS relieved the Circulating Nurse who was orienting the CNO. The ST said there was a lot of instruments that needed to be counted and moved out from the laparoscopic procedure and a new kit needed to be brought into the room for the open procedure.

The ST said she recalled the Surgeon gave them

Based on review of documentation, interviews with clinical staff and the Risk Manager, the Hospital failed to ensure the Hospital took actions aimed at performance improvement. Although the initial and final counts were documented as correct, a retained surgical sponge was identified on x-ray the day following surgery. As of the day of the survey, 4/28/11, the Hospital had not implemented any plans to safeguard patients against having such an event occur.

1) The Perioperative Nurse Manager and the Perioperative Nurse Specialist were interviewed in person on 4/28/11 at 2:20 pm. They said there is a special Quality Assurance Topic for near misses. They said a Graduate Student is working with them. They said the standard incident reporting system does not capture relevant data in this situation. They said they are currently inquiring what other Hospitals are doing in this situation and conducting a literature search. They said there was an initial meeting the day of the incident with most of the involved staff. The case was also discussed at the weekly safety meeting with chiefs the prior day. They said they are "still digging down" to identify the cause of the error/documentation of correct count, but with the outcome of a retained sponge. They said there is no resolution at this time. They said they do not want to rush on the analysis.

They said the Hospital had formed a Safety Culture Task Force in which any member of the clinical team could call a time out or huddle to discuss concerns/issues in a case. The PCS is a member of this task force and is a 24 year employee of the Hospital with long term OR experience.

During interview, the clinicians identified several factors which contributed to confusion and rush during the count procedures, yet none of the team members considered calling a time out prior to Patient #1 leaving the OR for a final x-ray.

2) The Risk Manager was interviewed in person on 4/28/11 at 1:50 pm. The Risk Manager [RM] said the Root Cause Analysis was protected peer information and was not shared with this Surveyor. The RM said the analysis was not complete and stressed the Hospital had 30 days to complete the analysis. The RM said the plan of correction was also not completed. The RM said that calls were made to other Hospitals for copies of their policies and they would be reviewed. At the time of the survey, there was no plan implemented to protect patients from having this type of incident/error occur again.