Intraoperative Consultation Quality Assurance

Quality assurance of intraoperative consultation (IOC) is typically part of a larger quality assurance (QA) plan for anatomic pathology or surgical pathology (Nakhleh and Fitzgibbons, 2005; Lester, 2006). Even though IOC is an integral part of surgical pathology, in most departments the IOC service operates as a unique subunit. The frozen section room often has a unique and separate physical location, specialized equipment, and possible additional staffing requirements. Many institutions have intraoperative standard operating procedures (SOPs) that are unique to that area or are clearly designated that way. To assure quality of IOCs, a laboratory director must address multiple aspects of practice. Traditional QA activity includes monitoring of five segments of quality, including preanalytic, analytic, postanalytic, turnaround time, and customer satisfaction (Nakhleh and Fitzgibbons, 2005). Assuring quality also includes addressing practice parameters in policy and procedures, as well as creating clear expectations. It all starts with a clear QA plan.

IOC Quality Assurance Plan

The goal of any QA plan should be to address the inherent risks involved in an operation (Valenstein, 2005). As stated before, this is typically part of the anatomic pathology or surgical pathology QA plan and not a plan on its own. In this chapter we will address aspects of practice that are relevant to IOC. The purpose of an IOC service is to manage specimens during surgical care and to assist the surgeon with intraoperative decisions.

In addition to quality monitors and quality improvement ideas, the plan should include specific policies and procedures outlined to assure quality and safety. In assuring quality, specific policies may be listed for addressing specific types of specimens (e.g., lymph nodes for lymphoma workup, muscle tissue for myopathy evaluation, kidney tissue for evaluation of glomerular disease) or policies that may impact the practice of pathologists (e.g., a policy outlining situations in which a second pathologist should be consulted). In assuring safety, policies addressing the safety of the employee should be considered (e.g., handling of hazardous specimens such as Creutzfeldt-Jakob disease or tuberculosis), as well as the safety of the patient. The plan could also include situations and examples where it may be inappropriate to cut a frozen section (e.g., bone).

Table 22-1 lists aspects of practice that should be included in the QA plan for IOC. Specific monitors designated to check on selected aspects of practice of IOC are also listed.

Table 22-1

Aspects of a Quality Assurance Plan Relevant to IOC

Purpose	This quality management plan is designed to assure that this laboratory meets regulatory and performance standards for quality and safety.
Domain and oversight	This plan is a part of the quality management plan for anatomic pathology and is under the direction of (lab director). This committee reports directly to (department of laboratory medicine and pathology QA committee). Some data may be shared with other departments (e.g., surgery), hospital QA committee, or risk management.
Policies and procedures	These may be included here if they address specific issues relevant to quality and safety.
Responsibility	A listing of individuals who are responsible for collection of data should be included with a timetable for the QA committee meeting and presentation of the data.

Aspect of Quality	Specific Monitors
Statistics	Number and location of IOCs Number of frozen sections Number of cases by service and clinician
Preanalytic	Specimen adequacy Remote site timely delivery Remote site scheduling
Analytic	Frozen section–permanent section discordance Frozen section–permanent section deferral
Postanalytic	Appropriate documentation of frozen section diagnosis Appropriate documentation of discordance Appropriate documentation of communication in instances of discordance
Turnaround time	TAT of single block cases TAT of multiple block cases
Customer satisfaction	Customer satisfaction survey may be part of more general surveys of the laboratory, usually every 2-5 years.

Policies and Procedures

General Safety

IOC is generally performed on fresh, unfixed tissues and presents a hazard for blood-borne and airborne infections (Occupational Safety and Health Administration–a and b). Whereas this risk is similar to gross-room dissection risk, pressure for a quick turnaround time may force compromise in handling of tissue. Safe handling of tissues should be emphasized during IOC. In addition to general blood-borne and airborne pathogen education and refreshers for all employees, consideration should be given to competency assessment specifically designed to evaluate employees engaged in fresh specimen handling. Also, departments should continuously examine all incident reports that result in employee injury, with specific attention to possible blood-borne and airborne pathogen infection.

Specific policies and procedures should be included in the gross-room manual that addresses what to do in cases with the potential of a specific infectious agent. Cases that must be addressed include Creutzfeldt-Jakob disease and tuberculosis (Occupational Safety and Health Administration–a and b). Specific policies should be in place regarding whether to cut tissue for frozen section analysis and, if performed, how to clean the infected equipment, including the cryostat.

From a general perspective, appropriate and adequate space, lighting, and equipment are assumed. However, there are many examples of personal injury due to inadequate or faulty equipment.

Patient Safety

Typically following an incident of diagnostic misadventure, many laboratories have chosen to have a second pathologist review a case at the time of IOC (Nakhleh et al, 2010). Usually this involves only selected cases, such as brain biopsies for a tumor or other potentially problematic specimens, such as thyroid. In most instances these types of policies are instituted after a mishap. Whereas there is no current literature to support an improvement in intraoperative accuracy, a second pathologist review of a case does appear to reduce potential disagreements in the final report.

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