Progression from on-site to point-of-care fine needle aspiration service: Opportunities and challenges

INTRODUCTION

After it started as an experimental procedure met with widespread skepticism, fine needle aspiration (FNA) has matured into a vital and dynamic diagnostic tool. This procedure is inherently a team function between the patient, the clinician and the cyto-pathologist. An active dialogue helps ensure diagnostic accuracy in an efficient and economical way. Specimen adequacy and triage, clinicopathologic correlation, and prompt ancillary testing form the linchpins of on-site FNA service and improved patient care. The value of such synergy cannot be over-emphasized. In the context of the current interest in personalized medicine and “transformational pathology”, point-of-care (POC) FNA represents an excellent example of a team approach for delivering personalized diagnostics and care in the most-efficient manner. We briefly present current practices in on-site FNA service and discuss the challenges and opportunities in extending them to a POC model in our institution.

NEEDLES AND FINE NEEDLE ASPIRATION

The distinctions between needle aspiration, FNA and core needle biopsy, although well known,[1–3] often contribute to confusion. Many a times the terms are used erroneously and interchangeably. While needle aspiration can be performed using 16–20 gauge needles, in the FNA procedures, tissue sampling is done employing a thinner (21–27 gauge) needle, generally attached to a 10 or 20 cc syringe and an aspiration device (handle/gun). Needle aspirations are often performed in dense tissues such as abdominal fat pad and soft tissue lesions. FNA uses the cutting properties of a needle bevel in conjunction with capillary action of the needle shaft to dislodge cells singly and in small clumps or micro-biopsies, preserving cytologic features and relatively few architectural features. Sample extraction and dislodging of tissues is also facilitated by suction applied by the syringe attached to the needle. FNA specimens generally are more concentrated with limited dilution by the fluids and contaminants. Aspirated specimens can be smeared in a number of ways.[45] The material obtained by these methods is well-suited for diagnosis. The risk of complications with FNA procedures is minimal. Hematoma may occasionally occur, usually without consequence.[6] There are occasional reports of tumor seeding[7] or fistula formation[8] following an FNA procedure, but it is difficult to prove causality in these rare events.

Core biopsy, on the other hand, is performed with a larger bore needle (10–16 gauges) and yields a larger quantity of tissue requiring histological preparation. This procedure is utilized for predictive and therapeutic studies in lesions of breast, lung, prostate, and other sites with a known or highly suspected malignancy. There is a greater risk for complications including hematoma, cyst and scar formation. Tumor seeding is also a recognized but rare complication of core biopsy.[9–12]

The number of anatomic sites amenable to FNA procedures has grown with improved imaging methods, the development of advanced endoscopic procedures, and greater clinician acceptance.[13–15] There are now relatively few sites that cannot be sampled by fine needle methodologies. Indeed, FNA interpretation facilities preoperative triage of specimens that would not otherwise be amenable to accurate diagnoses. Prior to the development of FNA, pancreatic lesions of nonaggressive radiology were often resected without antecedent tissue diagnoses. As imaging modalities have improved in their ability to detect these lesions, so have the endoscopic methods that make it possible to biopsy them and guide patient management.[16–18]

Localization of the lesion can be immediate, as in the case of a palpable nodule, or may require stepwise positioning of a needle under imaging guidance. Some minimal preparation may be needed for anesthesia or imaging. The time spent for the FNA procedure including on-site evaluation is dependent upon a number of considerations including service proximity, clinical interaction and facilities. The material obtained at each pass is generally smeared, stained and examined for adequacy as well as for interpretation.[245] Most FNA procedures with on-site evaluation require three or fewer passes per site and in our present set up can be accomplished in 20-40 minutes. Interpretive time is shortened and efficiency is improved by the on-site availability of a cytopathologist. Specimen processing using a number of techniques (on-site smear, cytospin, liquid-based preparation, Millipore filter, and cell blocks) is considerably faster than histological fixation and processing; most specimens are reported in less than 24 hours.

ON-SITE SERVICE: SPECIAL ADVANTAGES

An on-site interaction between the cytopathologist and the clinician permits opportunity to consult on the history, special issues for consideration, differential diagnosis, specimen triaging and use of ancillary studies. The interdisciplinary approach allows for continual education, understanding, and dialogue that directly benefits patient diagnosis and care.[19]

Patient care is improved when on-site interpretation helps in focusing any additional workup necessary for management. At our institution, FNA specimens with on-site interpretation are routinely triaged for ancillary studies including flow cytometry, molecular testing, microbiology and clinical chemistry (thyroglobulin, PTH, CEA and amylase).[20] This is especially beneficial when the real-time findings are unexpected. On-site assessment permits obtaining additional samples in cases of inadequate or nondiagnostic aspiration, thus increasing overall accuracy. This service also minimizes the number of necessary passes for a given site; in our practice, we rarely (<1%) perform more than three passes.

Thyroid FNA practice at our institution provides a case study in the costs and benefits of on-site service. These aspirations are performed in an interdisciplinary setting and collaboration with endocrinology, radiology and cytopathology departments. In this arrangement, thyroid nodule FNA has attained a 98% diagnostic rate, in concordance with histological diagnosis of 100% for malignant lesions, 67% for those considered suspicious and 56% for those considered indeterminate at FNA.[2122] The unsatisfactory rate is less than 4% for all FNAs and less than 1% for ultrasound-guided thyroid procedures. In contrast, FNA performed without on-site assessment has a reported nondiagnostic rate of approximately 20%.[22] Based on this data and on average cost per aspiration, it has been estimated that on-site service allows monetary savings on the order of $400,000 per annum at our institution. By examining a broad range of superficial FNAs using 1995 relative value units and reimbursements, Rimm et al., calculated savings of $250,000 to $750,000 per 1,000 FNAs performed, or approximately 55,000 RVU.[23]

In many facilities, resources do not always permit an interdisciplinary model; on-site service is often provided by cytotechnologists in a number of facilities. While an experienced cytotechnologist can provide on-site specimen adequacy in simple cases, complex and complicated and unexpected situations require additional professional support. FNA can also be performed by the clinician alone, placing the specimen or prepared slides in an appropriate preservative for delivery to the laboratory. This is sometimes the only practical arrangement. When a cytopathologist is not present for the FNA procedure, the clinician is deprived of an immediate evaluation of specimen adequacy and diagnosis and is forced to defer discussion of the diagnosis and subsequent management to the patient's next visit. Also, the number of suboptimal, unsatisfactory and unnecessary passes and preparations is increased considerably, thus affecting the cost and quality of care. Salient features of the sent-in and on-site FNA procedures are presented in Table 1. There is a distinct need for the laboratory and client interaction to improve patient care.

Finally, FNA can be performed by the cytopathologist alone. This arrangement although exciting and often advocated has drawbacks. When the clinician is not present at the time of the aspiration, the pathologist besides being deprived of potentially critical information may not sample the right lesion and perform the necessary additional ancillary studies critical for proper patient care. Establishing a separate clinic requires space, personnel, equipment, and regulatory compliance and a cost-benefit analysis. Also, in a large institution it may not always be convenient for the patient to find another location such as an FNA clinic for the procedure.

Challenges for delivery of on-site FNA service include coordination and scheduling, equipment, staff, space, and financial and administrative considerations. The system must be logistically and financially tractable. There is substantial one-time investment in equipment. There are recurrent expenses of the support staff needed for restocking the various supplies and specimen handling. Finally, recent changes in Medicare reimbursement policies for on-site adequacy or interpretation represent additional considerations-and perhaps challenges-for this service model.

Point-of-Care Service at the Perelman Center for Advanced Medicine (PeCAM)

The PeCAM at the University of Pennsylvania is a new 500,000 sq ft, five-story, $302 million, state-of-the-art outpatient facility [Figure 1]. In designing an FNA service for this new facility, we adopted the concept of "point-of-care" testing to reflect our commitment to bringing the best FNA practices directly to the bedside.

Challenges in designing point-of-care FNA services included (i) providing efficient service at multiple different locations, currently eight in number; (ii) meeting the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) requirements; (iii) complying with the Health Insurance Portability and Accountability Act (HIPAA) regulations for patient privacy; (iv) complying with infection control regulations; (v) ensuring clinical effectiveness; and finally (vi) meeting the academic mission of the institution.

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Figure 1

Perelman Center for Advanced Medicine (PeCAM), the new outpatient facility at the University of Pennsylvania. Point-of-care FNA services are provided at various locations throughout the building

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FNA SERVICE LOCATIONS

The PeCAM building is divided into three major wings. In each, patient areas are separated from “white coat” areas. Health care providers have separate sets of elevators and hallways, access is regulated with card keys and trilogy locks. Presently, FNA services are provided at eight service locations [Table 1 and Figure 2]. Each locus is equipped with a dedicated FNA room or station. A cytopathology reading room and associated support facilities are located on the ground floor [#9, Figure 2]. The endoscopy suite [#8, Figure 2] used for bronchoscopy as well as ultrasound guided imaging FNA procedures and cytopathology reading room (#9) are situated in the same core, reducing travel and turnaround time for the care of patients under anesthesia. This layout allows almost all FNA procedures to be completed in less than 15 minutes. While multiple-site sampling, such as in bronchoscopy, may require additional time, in other settings (e.g., thyroid clinic #4) a number of patients can be served sequentially in a short time. In situations with overlapping demands for the FNA service, precedence, is given to the endoscopy patients under anesthesia. Variable number[15–29] of FNA procedures is performed daily; more cases being accessioned on days of the endocrine and follow up clinics.

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Figure 2

PeCAM floor plans with designated cytopathology service sites.

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EQUIPMENT AND SUPPLIES

Each of the current eight FNA locations is equipped with a microscope permitting multiple simultaneous viewers, a laboratory refrigerator for reagents and specimens, a networked computer, a printer and supplies. Stains and Normsol^® in Coplin jars are kept refrigerated, and pre-numbered glass slides, syringes, needles and other items are kept locked at each location. The POC FNA program relies upon the services of a central cytopathology laboratory that is responsible for specimen handling, drop-offs, supplies and restocking. To prevent cross-contamination, each on-site procedure is performed with a fresh set of stains and staining jars.

The design of a multi-site POC FNA program required a significant investment in microscopes and video equipment. High-resolution cameras and screens with live video Axis Camera transmission capabilities are available in endoscopy and the cytopathology reading room (locations #8, #9). A high-definition television is mounted in the mammography station (location #1) for radiograph review. FNA carts of 2 ^nd and 3 ^rd generation[25] are used in the endocrinology and lung center locations (#3, #4) and other infrequent sites such as radiation oncology and pulmonary medicine. Multi-headed microscopes are available in the cytopathology reading room (#9). The remaining facilities (#5, #6 and #7) utilize a digital camera and high-definition LCD for multiple viewers. Table 2 summarizes the FNA facilities at these POC service locations. PeCAM facilities although somewhat under used presently, have been designed keeping in view the growth and utilization studies undertaken by the Health System. Additional staffing and TeleCyP will form a major component of the fully functional Center. Superficially, the on-site and POC FNA services appear similar. There are however, subtle differences which provide a more efficient, economical and the state of the art patient care FNA service. Table 3 summarizes the comparison of the two modalities.

FNA service staffing and workflow

Requests for FNA are received at the front office in the main hospital, the team on call is informed of the location and demographics, look-up documents and bar-coded labels are printed and provided to the team along with the timed request form. For endoscopic and endocrine cases, a list is available in advance and documents are prepared in advance. The FNA team including a cytopathologist, a fellow and a resident if available, is dispatched. An FNA cart or a carryall [Table 4 and Figure 3] containing the essential supplies is brought to the bedside and the procedure is performed. Following on site interpretation, the labeled specimen with documents is double-bagged and returned to the laboratory for further processing.

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Figure 3

A “carryall” container with a lid used to bring supplies to the bedside. Smears are prepared and taken to an adjacent satellite laboratory for staining and interpretation.

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Table 4 Contents of a standard cytopathology carryall

Specimen collection

Syringes (10cc and 20cc), clear hub, with screw or Luer-Lock fittings

Hypodermic needles (#18, 20, 23, 25) in 1.0” and 1½” lengths

Aspiration handle (“gun”) for 10cc and 20cc syringes

Specimen collection buffer (Normosol®) in screw-top containers

Alcohol/iodine pledgets, gauze, tape, bandages

Gloves, paper towels, pencils, grease pencils, pens

Blank paperwork (requisition forms, labels, diagnosis reporting forms)

Smear preparation and evaluation

Glass slides, pre-numbered for successive passes (1 through 5)

Diff-Quik stains, 2 sets of 3 Coplin jars

Water container for destaining

Specimen transport

Slide storage box

Ethanol container, leak-proof, for fresh fixed smears

CONCLUSIONS

With careful planning, broad institutional support and committed resources, we have been able to construct a point-of-care FNA service that confirms to current regulations, health care needs and our academic mission, providing an economical, accurate, rapid and goal-directed diagnostic modality. It also offers an opportunity for improved patient care in the future. This paradigm can be adapted to meet the needs of other institutions as a valuable component of contemporary health care.

DECLARATION OF COMPETING INTERESTS

The authors declare that they have no competing interests.

AUTHORSHIP STATEMENT BY ALL AUTHORS

Each author acknowledges that this final version was read and approved. All authors of this article declare that we qualify for authorship as defined by ICMJE http://www.icmje.org/#author. Each author has participated sufficiently in the work and take public responsibility for appropriate portions of the content of this article.

ETHICS STATEMENT BY ALL AUTHORS

As this is case report without identifiers, our institution does not require approval from Institutional Review Board (IRB) (or its equivalent)

EDITORIAL / PEER-REVIEW STATEMENT

To ensure integrity and highest quality of CytoJournal publications, the review process of this manuscript was conducted under a double blind model (authors are blinded for reviewers and reviewers are blinded for authors) through automatic online system.