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Based on review of documentation and interviews, the Hospital failed to ensure that all practitioner's orders, nursing notes, reports of treatment, medication records, radiology and laboratory reports and vital signs and other information necessary to monitor the patient's conditions.

NB: Please see Tag 0951 for more information regarding background information about the Patient and Operating Room Policy regarding counting of surgical items.


Findings included:

Please see Tag # 0951 for more information.

1) Circulating Nurse #2 was interviewed in person on 8/4/10 at 2:12 pm. Circulating Nurse #2 said she could not recall if the surgical scanning machine was used during an emergency surgery conducted on 4/3/2009. Review of the Intraoperative Nursing Note dated 4/3/2009, comments section, did not indicate if the surgical scanner was used. Circulating Nurse #2 said that if the surgical scanner is used, the staff will document it in that section.

2) The Nursing Manager of Surgical Services and the Associate Chief Nurse were interviewed in person on 8/4/2010 at 1 pm. The Nursing Manager of Surgical Services and the Associate Chief Nurse said that policy requires that in emergency surgery cases, a X-ray will be obtained prior to closure of the abdomen to ensure that no retained surgical items remain in the body cavity. Review of the Intraoperative Nursing Note dated 4/3/2009 indicated the case was designated as an emergency. Circulating Nurse #2 failed to document if an X-ray was obtained. Review of the medical record did not indicate that an X-ray was obtained.

3) Interview with the Nursing Manager of Surgical Services indicated that the hand held surgical scanner, which is used as a second count of surgical sponges and items, was not used during the surgical procedure performed on 4/3/10.

4) Review of the Intraoperative Nursing Note dated 7/6/2010 indicated the Patient had emergency surgery to remove a retained surgical sponge from the surgery performed on 4/3/2009. This Intraoperative Nursing Note also did not contain documentation regarding use of the surgical scanner and if an X-ray was obtained prior to closure of the abdomen.

5) Review of the Intraoperative Nursing Note dated 4/3/2009 indicated that the Registered Nurse Circulator column for "relieved by" was not correctly filled out. As a result, the time the first registered nurse circulator was relieved by RN Circulator #2 is not known.

Based on review of documentation, observations, review of Hospital operating room policy regarding counting of surgical items and interviews, the Hospital failed to ensure that policies governing surgical care were designed to assure the achievement and maintenance of high standards of medical practice and patient care.


Findings included:

Background information:

Review of the Patient's medical record indicated the Patient had surgery on 4/3/2009 for emergency repair of a perforated duodenal diverticulum. Review of the Intraoperative Nursing Note dated 4/3/2009, section on "Counts" indicated the first, second and third closure counts were correct. The first count was conducted by the Scrub Technician and Circulating Nurse [RN #1]. The second and third count was conducted by the Scrub Technician and Circulating Nurse [RN #2].

Review of the Patient's medical record indicated the Patient presented to the Emergency Department on 7/5/2010 for abdominal pain. Review of the X-Ray report documentation indicated the presence of a foreign object in the abdomen. The Patient had surgery on 7/6/2010 where a surgical sponge was removed that was encapsulated. The medical record indicated the surgical sponge was left in the abdominal cavity from the surgical procedure performed on 4/3/2009. The foreign body was removed and the Patient recovered without incident. The Patient was discharged to home on 7/10/2010.

Findings:

1) Review of the Hospital Policy titled: Sponge, Sharp, Instrument and Miscellaneous Count indicated that all counts will be done audibly and viewed concurrently by a perioperative nurse and the scrub nurse or technician. The circulating nurse and scrub person have equal accountability in keeping an account of the countable items.

2) Review of the section titled: "Bar-coded sponges", point 10, indicated that laparotomy and raytec gauze sponges will be bar-coded. When using these sponges, along with doing an audible count, scan them with the sponge scanner prior to counting and point 11, the bar-coded sponges will be scanned prior to an initial sponge count.

3) Review of the section titled "Closing Counts", point 30, indicated that the audible count is completed and verified with the sponge count scanner prior to moving the patient out of the room and point 31 indicated the Surgeon must be verbally informed of every count result.

Review of the section titled "Managing High Risk Cases", point 47, indicated that cases at high risk for retained foreign bodies include emergency surgery.

4) Review of the section titled "X-rays", point 49 indicated an x-ray is performed at the time of closure on any abdominal or thoracic operation whenever any TWO of the following risk factors are present: a. emergency operation b. BMI greater than 3.5 c. duration greater than 3.5 hours d. more than one relief e. significant change in the operative plan once the procedure has started.

5) Interviews on 8/4/2010 with the Chief of Surgery at 11:50 am; Manager of Surgical Services at 1pm and the Associate Chief Nurse indicated the surgical service purchased hand held scanner machines to count surgical sponges and laparotomy sponges. The scanner serves as a double check to reduce human error in counting surgical supplies and reduce the risk of a retained surgical object. The clinicians said the hand-held scanner must be used for every surgery in which a body cavity is opened. The clinicians said the scanner may not be used in emergency cases based on lack of time. The Clinicians said that for emergency surgical cases, an x-ray must be obtained prior to final closure of the abdomen to ensure there are no remaining surgical objects prior to closure.

However, as noted in #4 above, review of the Hospital Policy titled: Sponge, Sharp, Instrument and Miscellaneous Count did not clearly indicate that an X-ray must be obtained at the conclusion of a case that was considered an emergency. The policy stated that two factors had to be present for an X-ray to be mandatory. Review of the Hospital policy also did not clearly indicate when the hand held scanner must be used, e.g. during open body cavity surgeries, or that an x-ray must be obtained when the scanner is not used.

The policy did not clearly reflect Hospital Administrative expectations for clinical practice/standards.

6) Review of the Policy indicated that there was no criteria as to when the scanner MUST be used and in what circumstance the scanner may not be used, (e.g. for emergent cases in which there is no time to either count or use the scanner or in cases in which no body cavity is opened, such as hand surgery).

7) Observations of the hand held scanner conducted at 1pm on 8/4/10 indicated the scanner is used to count the initial packages of either 5 or 10 during the initial count and then the scanner is used for the second and third counts and final closure counts. The scanner provided an audible count and a final audible noise when the count was complete and correct. The machine also provides a stored record of all surgical cases and counts. A printable receipt is also available.

8) Review of the scanning receipts indicated that no scanner was used during the surgery performed on the Patient on 4/3/2009. Review of the Intraoperative Nursing Note indicated the surgery was classified as an II E or an emergency case. Review of medical record documentation did not indicate that a final x-ray prior to closure was obtained before the final suturing of the Patient's abdomen.

9) Although the Intraoperative Nursing Note dated 4/3/2009 indicated the initial, first closure and second closure were correct; the patient outcome indicated there was a retained surgical sponge noted over one year after the surgical procedure.

10) Interview by telephone with the Surgeon who performed both operations on 4/3/2009 and 7/6/2010 indicated that he classified the surgery as "urgent" in both cases. The Surgeon said that urgent to him meant that surgery had to be performed within a short amount of time, but not that the surgery had to be performed immediately, within minutes, to save the patient's life.

11) Interviews with the involved clinicians on the 4/3/2009 surgical case, documentation on the Intraoperative Nursing Note for surgery performed on 4/3/2009 and 7/6/2010 and interview with the Surgeon indicated that the Surgeon had a different classification of what constituted an emergency than the rest of the surgical team. As such, the expectation of obtaining a final X-ray before closure of the abdomen was not made clear to the entire surgical team. Interviews with the second Circulating Nurse: RN #2 and the Scrub Technician conducted on 8/4/10 indicated that they were not sure of what the surgery classification was, even though the Intraoperative Nursing Note was made available that clearly indicated the 4/3/2009 surgery was considered an emergency case.

12) Interviews with the Operating Surgeon, RN #2 and the Scrub Technician on 8/4/2010 indicated the operating room team staff were not clear of: 1) what the difference was between an "urgent" and an "Emergency" surgical case 2) what the expectations were for obtaining a final X-ray at the conclusion of a case and 3) when using the surgical scanner/counter was mandatory.