Safe Surgical Counting Procedures in the Hybrid Cardiac Catheterization Laboratory

What is a hybrid cath lab?

The 2012 American College of Cardiology Expert Consensus on Cardiac Catheterization Laboratory Standards defines a hybrid cardiac catheterization lab as:

“an integrated procedural suite that combines the tools and equipment available in cardiac cath with anesthesia and surgical facilities, and possesses the sterility of an operating room. Procedures suited for a hybrid room include those requiring surgical access, those where conversion to open surgical procedure may be required, hybrid treatments, device implants or removal, and certain emergency procedures.”¹

Prior to the development of the hybrid cardiac catheterization lab, open cardiac surgical interventions in the United States were typically reserved for the operating room environment. Cath labs were not able to deliver the same level of care as the operating room because they were not maintained as sterile surgical suites, there was minimal space and equipment on hand to perform surgery, and cath lab staff was not trained in surgical tenets. Development of the hybrid cath lab model addressed many issues that prohibited surgery in the non-hybrid cath setting. Modern hybrid cath lab suites are maintained to surgical operating room standards. Surgical supplies and equipment are kept on hand, are readily accessible, and cath lab staff is trained to assist a surgical team.

Safety concerns drive initiative

Cincinnati Children’s Hospital Medical Center (CCHMC) is a 543-bed, standalone children’s hospital with a full-service cardiology program, including heart transplant. There are currently two adjacent hybrid cath labs performing over 800 procedures annually. The CCHMC hybrid cath lab recently underwent an internal safety review that included an inspection of evidence surrounding the counting of surgical items. Currently, surgical item counting is being performed on all hybrid surgical procedures in the cath lab at CCHMC, but at the time of the process review, was not being performed during percutaneous cases without surgical components. Our institution’s concern for patient safety drove an initiative examining the use of only x-ray detectable sponges, along with counting all sponges and sharps on every procedure, including percutaneous procedures.

The Association of Surgical Technologists (AST) considers surgical items to be any sponge, laparotomy sponge, needle, or instrument used during surgical procedures.² A large comparison study from 2009³ indicates that actual retained surgical items in pediatric surgery within the United States are relatively infrequent (1:32,672). No data regarding retained surgical items during hybrid procedures could be found. 

A culture of safety

Patient safety is central to all patient care activities within CCHMC. Within our institution, the James M. Anderson Center for Health Systems Excellence is the coordinating division of quality improvement and strategic initiatives. The Anderson Center summarizes CCHMC’s safety efforts⁴ in its statement that “Keeping our patients safe is a pre-condition for everything we do.” A strategic organizational goal of CCHMC is to eliminate all serious harm to patients by June 30, 2015.⁴ Central to this goal is continual review and improvement of patient care processes. 

Implementing a surgical item counting guideline for all procedures, encompassing both percutaneous and surgical, aligns the practices of our lab with safety standards described by the Association of Operating Room Nurses⁵ (AORN), AST2, and the National Patient Safety Goals and Patient Safety Initiatives.⁶ Practices recommended by AORN⁵ state “sponges should be counted for all procedures in which the possibility exists that a sponge could be retained.” All sharps and other surgical items that are opened on the sterile field should be accounted for during all procedures for which sharps and miscellaneous item are used.⁷ AST publishes practice standards for surgical technologists in the United States, and recommends that sponges be counted on all procedures that have possibility of a foreign object being retained, in order to support patient safety practices. 

Peri-operative procedures⁸ followed at CCHMC align with AORN perioperative standards and recommended practices.⁵ The CCHMC sponge, sharp and miscellaneous item count procedure guideline directs that all sponges, sharps and miscellaneous items should be accounted for and the count reconciliation must be documented on every surgical or invasive procedure. Our institutional guidelines contain a critical definition of an invasive procedure: any procedure that exposes patients to more than minimal risk, including those involving the puncture or incision of the skin, as well as those performed in an interventional radiology area or others outside the operating room. 

Why count in percutaneous procedures? 

The complex procedures performed in hybrid cardiac cath labs are growing more technologically advanced and addressing increasingly difficult clinical presentations. The difference between hybrid cath procedures, other interventional procedures, and minimally invasive procedures is increasingly difficult to discern.⁹ Many of the procedures now being performed percutaneously were once strictly open surgical procedures. Case complexity and treatment modality advancement require an increasing diligence and awareness of potential safety issues. A recent multi-center registry analysis¹⁰ evaluated adverse events in 128 hybrid procedures. In this analysis, 54% of the studied procedures took place in the cath lab setting. In addition, 63% of the total cases with adverse events were considered emergent or non-elective procedures, with unplanned surgical components. Several limitations of this registry analysis make it difficult to draw significant conclusions regarding any association between the adverse events and conversion of the cath procedure to an open surgical intervention. Of interest are the increased numbers of emergent and non-elective procedures within the small number of hybrid procedures analyzed. All transcatheter procedures, whether interventional or diagnostic, carry some risk for a complication requiring open surgical intervention. 

Children’s Hospital Boston collected data over one year to determine adverse event rates in the population of cardiac catheterization patients at their institution.¹¹ In 2008, Children’s Hospital Boston found that 1% of their total case volume, or 17 patients, resulted in an adverse event that required extracorporeal membrane oxygenation (ECMO) or surgical intervention.¹¹ In a similar study recently conducted at Mayo Clinic¹², 2% of their cases had some varying type of complication from cardiac catheterization. Two of the complications included emergent surgical intervention, one due to a tangled coil in the chordae of the tricuspid valve, and the second due to perforation of the left ventricular outflow tract with a wire. 

In the event a transcatheter procedure becomes an open surgical intervention in an emergent or unplanned manner, there is a risk of intermingling non-x-ray detectable sponges currently used during percutaneous procedures with x-ray detectable sponges used for the surgery. A sponge that is not x-ray detectable and not accounted for in the transition to open surgical intervention can become a retained surgical item. Gawanda et al¹³ confirms that risk of retained surgical item is increased in cases of emergency surgery or unplanned change in the surgical procedure. The Joint Commission¹⁴ considers retention of a surgical item a never event in the surgical care continuum.

Surveying like facilities on percutaneous procedure counting

Performing surgical counting and the use of x-ray detectable sponges is the care standard for all combined hybrid cath procedures. However, based upon survey of like institutions, routine surgical item counting and the use of x-ray detectable sponges is not standard for percutaneous transcatheter procedures which do not have a known scheduled surgical component. 

The authors conducted a telephone survey of 15 pediatric and adult hybrid cardiac cath labs in the United States where a series of questions were posed to determine surgical item counting among like institutions (see Appendix A for a complete list of survey questions). The queried institutions were made aware that the purpose for collecting this data is the implementation of a guideline for the counting of all surgical items prior to any cases in the cath lab, including percutaneous procedures. None of the facilities contacted are currently counting for percutaneous procedures, nor are they using x-ray detectable sponges for percutaneous procedures. However, of the 15 facilities contacted, the anecdotal response to the proposed guideline was positive. Two of the targeted institutions asked that the authors forward the final position paper, as well as any additional information for the implementation of counting all procedures in the cath lab. The clinical contacts at these two facilities indicated that if this process were implemented at CCHMC, their institutions would likely also create their own guideline for using x-ray detectable sponges for all procedures, and counting surgical items for each procedure done in the cath lab. As of this writing, our team is in the process of implementing this practice as it awaits review by the CCHMC policy and procedure committee. The committee will either approve the initiative or offer suggested changes to permit formal implementation of these guidelines.

Conclusion

Retained surgical items are estimated at 1500-2000 incidences per year, with surgical sponges comprising the majority of retained items.¹⁵ Review of Joint Commission⁷ investigational data indicates that unintended retention of a foreign body is the most reported sentinel event in 2011 and 2012. A paucity of research has been done supporting the counting process and use of x-ray detectable sponges for percutaneous procedures that do not include a scheduled surgical intervention. Eliminating all risk for transcatheter complications that could result in an unexpected surgical intervention or repair is impossible. 

No institutions contacted for this initiative are currently using peri-operative surgical item counting guidelines for percutaneous procedures. Alignment of cath lab procedures with institutional perioperative procedural guidelines and AORN standards can aid efforts to mitigate the risk of retained surgical item in the event of an unexpected need for surgery during a cardiac catheterization procedure. Consistent practice and patient care among the peri-operative, interventional radiology, and cath lab teams within any institution are critical to a goal of eliminating all serious patient harm. The risk of retained surgical item is small, but has a potentially severe patient outcome. Counting of all surgical items for every case, whether scheduled hybrid, unexpected hybrid, or percutaneous, is a natural progression for hybrid cath labs today. In an effort to augment patient safety, institutions should adopt the guideline of using only x-ray detectable sponges for all procedures in the cath lab. 

The authors can be contacted via Michael Harris at michael.harris@cchmc.org.

References 

1. Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers CE, et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012 Jun 12;59(24):2221-305. doi: 10.1016/j.jacc.2012.02.010.
2. Association of Surgical Technologists. (2013). Recommended standard of practice for counts. Available online at https://www.ast.org/. Accessed November 26, 2013.
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