New York State Department of Health - NYPORTS
NYPORTS News & Alert
|Department of Health, Issue 11||September 2002|
Retained Surgical Sponges
The retained surgical sponge/lap pad occurrence is less likely to garner public notoriety typical of a wrong site surgery. However, a NYPORTS analysis completed in 1999 (News and Alert #3) and updated in July, 2001 (News And Alert #9) found that surgical sponges and lap pads are the most frequently retained foreign objects after the surgical procedure. Retained sponges/lap pads can result in serious conditions including sepsis, intestinal obstruction, fistula or abscess formation and adhesions. A secondary surgical procedure is often required for removal of the retained foreign item.
The NYPORTS findings have prompted an interest in retrospective analysis of the Root Cause Analysis (RCA’s) submitted for code 913 (Unintentionally retained foreign body due to inaccurate surgical count or break in surgical technique). The purpose of the analysis is to identify methods and suggestions presented in the RCA’s that might improve the accuracy of the surgical count and decrease the occurrence of a retained surgical sponge or lap pad.
Many corrective actions from RCA’s suggest utilization of x-ray to identify retained foreign bodies. The use of sponges containing a radiopaque marker substantially improves the ability to locate them in an x-ray. While this is a widely used practice, it does not prevent the retention of surgical sponges. Although the use of x-ray is a standard diagnostic tool in locating a retained sponge or lap pad, there can be great variability in their appearance, leading to diagnostic misinterpretations. It may be helpful for facilities to maintain a collection of examples of the x-ray appearance of retained surgical sponges to assist the Radiologists/Surgeons with identification.
The Association of Operative Registered Nurses (AORN Journal Dec 1999) recommends that sponges be counted:
- Before the procedure to establish a baseline,
- Before closure of a cavity within a cavity,
- Before wound closure begins,
- At skin closure or end of procedure, and
- At the time of permanent relief of either the scrub person or the circulating nurse.
Also, sponges should be counted and recorded when added to the field.
RCA’s note that even with this meticulous care, inaccurate counts can occur when surgical sponges stick together or when situations interrupt the counting process (common root causes). Additional suggestions compiled from NYPORTS RCA’s include:
- Using two individuals to perform the surgical count, instead of one.
- Consulting the attending radiologist to determine which radiographic pictures would be most beneficial in locating a retained sponge or lap pad.
- Developing protocols for extended situations that may warrant x-ray examination in addition to surgical counts, such as when surgical sponge count is impacted by emergent situations.
- Considering a protocol to account for the use of an unusual or different type of sponge/lap pad, other than what was planned for procedure.
Looking at Prophylaxis for Thromboembolic Disease
Proper prophylaxis plays a major role in the prevention of unexpected adverse occurrences due to PE or DVT. However, despite the most ardent efforts, it is not effective in every case. The process for identifying risk factor categories for thromboembolism and the resulting prophylaxis varies from facility to facility. Some facilities have developed a thromboembolism risk factor assessment tool, which assigns a designated number or score to a variety of risk factors to determine whether a patient is at low, moderate or high risk for a developing a PE/DVT. An assessment of several thromboembolism risk factor assessment tools, which were shared with the NYSDOH, revealed that facilities assign different scores and weights to the same risk factor, and that the number of risk factors used varies. For example, at one facility the risk factor score for prior DVT is assigned a score of 1. At another facility, the same risk factor is given a score of 3. Since the risk categories are determined by the sum of these scores, the same patient could be potentially considered a moderate risk at one facility and at high risk at another, changing the agent and modalities for prophylaxis accordingly.
A recent research study at Brigham and Woman's Hospital (Goldhaber, Dunn, and MacDougal, 2000) calculated percentages of the patients in the study who developed venous thromboembolism (VTE) with 0-4+ risk factors. The study also found that most patients who developed secondary VTE had multiple risk factors. For example, 101 cases had two risk factors, 113 had 3 risk factors and 104 cases had 4+ risk factors. The research study also found that most deaths due to PE in this study population were related t failed versus omitted prophylaxis. The study suggests that quality improvement committees consider more intensive prophylaxis of high-risk patients and conduct meticulous follow-up of these patients to ensure successful outcomes. Based on this study, hospitals should consider examining their thromboembolism risk factor assesssment tools to assure proper patient risk categories are in place and proper prophylaxis occurs in all risk categories.
Goldhaber, S., Dunn, K., and MacDougall,R. (2000).
New onset of thromboembolism among hospitalized patients at Brigham and Woman's Hospital is caused more often by prophylaxis failure than withholding treatment. Chest, 118:1680-1684.
Reporting an unexpected death related to PE/DVT (even when prophylaxis was given) allows trends to be identified by the retrospective analysis of statewide RCA submissions, that may not be detectable by an individual facility. The 915 definition does not include language regarding preventability or prophylaxis. Current analysis of high risk populations in the 915 study sample does not support modifying the reporting criteria. A Data Analysis Panel (Clinical Specialists) has recently begun to study the qualitative and quantitative information from the RCA submissions and will be providing feedback to hospitals.
Top 5 NYPORTS Procedures Associated with DVT:
- Total Knee Replacement
- Total Hip Replacement
- Venous Catheterization
- Open Reduction/Internal Fixation of Femur
- Partial Resection of Small Intestine
Top 5 NYPORTS Procedures Associated with PE:
- Total Knee Replacement
- Incision/Excision and Occlusion of Abdominal veins
- Open Reduction/Internal Fixation of Femur
- Total Hip Replacement
- Total Abdominal Hysterectomy
A Matter of Laterality
The NYSDOH evaluated Root Cause Analysis submissions for wrong surgical components in total knee replacement systems, and concluded that the femoral component of this system is the only part that requires laterality verification. Wrong knee component occurrences are a continued problem identified by NYPORTS code 912 (Incorrect procedure or treatment-invasive). Although not on the list of Specific Pre-op Protocols, implant device verification and the communication to effectuate this process is recommended in the Pre-Operative Protocols Final Report (Available on the DOH website at http://www.health.state.ny.us).
Below are some of the corrective actions compiled from the evaluation of RCA’s submitted for this occurrence:
- Evaluate the packaging of knee component parts, and consult your component vendor regarding packaging issues, (Root causes regarding laterality describe exceptionally small font for the words “left” and “right” on the component packaging).
- Facilitate education through vendor workshops.
- Develop a Device/Implant confirmation form, for selecting and signing for component parts. This tool might detail a 3-4 step verification process initiated by the surgeon. The circulating nurse would verify the device/implant and state size and laterality of the component. The nurse will show components to the surgeon prior to opening them and place them on the sterile field.
- It may be helpful to separate components on supply carts and storage areas by laterality, as well as size.
Complicated Cases-Which One Would You Report?
Read each of the following cases studies to determine which case should be reported to NYPORTS.
A patient underwent an urgent tricuspid valve replacement, during which vegetations from endocarditis were well noted. The patient developed an acute abdomen and after evaluation was taken to the OR for a colectomy and end ileostomy due to gangrenous colon. The patient subsequently expired. The patient's pre-existing condition was Candida Endocarditis, with resulting tricuspid insufficiency, renal failure, and sepsis.
A patient underwent surgical intervention for a large tumor removal, developed a pulmonary embolism and expired. SCD boots were used immediately postoperatively. Anti-coagulant therapy was contraindicated. The patient was at high risk for Diabetes Inciptius related to tumor location, and required the use of the drug, DDAVP (a known platelet activator). Pharmacy literature states that there have been rare reports of thrombotic events following administration of DDAVP in patients predisposed to thrombus formation.
Answer #1 - Not reportable
It was concluded that the patient in case #1 had complications related to underlying fungal endocarditis that likely precipitated this unfortunate event. The gangrenous bowel was likely related to the effects of hemodynamic deterioration resulting from embolized fragments of vegetative growths from the heart and its effect on mesenteric perfusion. In addition, it was concluded that the septic condition and surgical stress contributed to the death.
Answer #2 - Reportable
The patient in case #2 did not suffer a PE as a result of underlying disease, but related to the known risk factors. Risk factors alone do not exclude an occurrence from NYPORTS 915 code reportability. This case should be reported as a 401 and 915.
Through a joint effort, the NYSDOH and HANYS will present videoconference training on November 4, 2002. Proposed topics include comparative reports, RCA quality initiatives, enhancements of the NYPORTS I/E list and definitions manual, and NYPORTS data/lessons learned related to unexpected deaths. If you are interested in attending, please contact HANYS at (518) 431-7600.
NYPORTS Statewide Council Meeting
The NYPORTS Statewide Council will meet on September 27, 2002 at the School of Public Health, Rensselaer, from 10:00 a.m.- 3:30 p.m.
For all medication error submissions (108-110), please include the corresponding Detail Code (915-920) and RCA.
AHRQ GRANT UPDATE
The NYSDOH, in conjunction with the University of Albany School of Public health (SPH), was awarded a patient safety grant by The Federal Agency for Healthcare Research and Quality (AHRQ). The funding period is 09/30/01 through 08/31/04. Updates will be regularly provided.
The patient safety Project encompasses two initiatives:
- An effort to improve the quality and completeness of reporting under NYPORTS, and
- Efforts to reduce the occurrence of adverse outcomes through sponsorship of three demonstration projects involving networks or groups of hospitals that study a common and preventable adverse outcome and develop and test initiatives to reduce that outcome.
Awards were made for three Patient Safety Demonstration Projects during June, 2002 for the study period 8/15/02-8/14/04. Hospital groups participating are:
- Code 401/402- (new documented PE, New documented DVT)
Lead organization- Strong Memorial Hospital. Participating hospitals: Highland Hospital, FF Thompson Hospital, St. James Mercy Hospital, and Jones Memorial Hospital.
- Code 604- (Acute Myocardial Infarction unrelated to a cardiac procedure)
Lead organization- New York Presbyterian Hospital, Columbia Presbyterian Center. Participating hospitals-New York Methodist Hospital, St. Barnabas Hospital, White Plains Hospital Center and NY Hospital Center-Queens
- Code 808- (Post-op wound infection following clean or clean/contaminated case requiring drainage or hospital admission within 30 days).
Lead Organization- Westchester Medical Center. Participating hospitals- Benedictine Hospital, St. Agnes Hospital, and Ellenville Regional.Hospital.