Clinical and Financial Implications of Second-Opinion Surgical Pathology Review.

OBJECTIVES: Second-opinion pathology review identifies clinically significant diagnostic discrepancies for some patients. Discrepancy rates and laboratory-specific costs in a single health care system for patients referred from regional affiliates to a comprehensive cancer center ("main campus") have not been reported. METHODS: Main campus second-opinion pathology cases for 740 patients from eight affiliated hospitals during 2016 to 2018 were reviewed. Chart review was performed to identify changes in care due to pathology review. To assess costs of pathology interpretation, reimbursement rates for consultation Current Procedural Terminology billing codes were compared with codes that would have been used had the cases originated at the main campus. RESULTS: Diagnostic discrepancies were identified in 104 (14.1%) patients, 30 (4.1%) of which resulted in a change in care. In aggregate, reimbursement for affiliate cases was 65.6% of the reimbursement for the same cases had they originated at the main campus. High-volume organ systems with low relative consultation reimbursement included gynecologic, breast, and thoracic. CONCLUSIONS: Preventable diagnostic errors are reduced by pathology review for patients referred within a single health care system. Although the resulting changes in care potentially lead to overall cost savings, the financial value of referral pathology review could be improved.

In-laboratory breast specimen radiography reduces tissue block utilization and improves turnaround time of pathologic examination.

BACKGROUND: This study was performed to determine whether in-laboratory specimen radiography reduces turnaround time or block utilization in surgical pathology. METHODS: Specimens processed during a 48-day trial of an in-lab cabinet radiography device (Faxitron) were compared to a control group of specimens imaged in the mammography suite during a prior 1-year period, and to a second group of specimens not undergoing imaging of any type. RESULTS: Cases imaged in the mammography suite had longer turnaround time than cases not requiring imaging (by 1.15 days for core biopsies, and 1.73 days for mastectomies; p < 0.0001). In contrast, cases imaged in-lab had turnaround time that was no longer than unimaged cases (p > 0.05 for core biopsies, lumpectomies and mastectomies). Mastectomies imaged in-lab required submission of fewer blocks than controls not undergoing any imaging (mean reduction of 10.6 blocks). CONCLUSIONS: Availability of in-lab radiography resulted in clinically meaningful improvements in turnaround time and economically meaningful reductions in block utilization.

Data-Driven Development of an Institutional "Gross-Only" Policy for the Examination of Select Surgical Pathology Specimens.

OBJECTIVES: To determine diagnostic, workflow, and economic implications of instituting a gross-only policy at our institution. METHODS: Retrospective (2017) key word searches were performed to identify "gross-only" cases for which microscopic evaluation could potentially be omitted, but was performed, and those who underwent gross evaluation per surgeon request. Cases were evaluated for type(s), part(s), block volume, turnaround time, demographics, and diagnosis. Laboratory costs and reimbursement were evaluated. RESULTS: In total, 448 potential gross-only cases with 472 specimens consisted of atherosclerotic plaques (33.5%), bariatric stomach/bowel (32.6%), hernia (15.7%), heart valves (12.7%), and other (5.9%). Four (2.6%) bariatric surgery cases had Helicobacter pylori infection; these were the only cases with "significant" histologic findings. Cost analysis revealed that converting all potential gross-only specimens to gross only would result in overall losses based on average reimbursements, most influenced by bariatric specimens (Current Procedural Terminology code 88307), comprising 65.2% of estimated loss. CONCLUSIONS: Establishing a gross-only policy should be guided by established recommendations but institutionally individualized and data driven. It was reasonable for us to establish a gross-only policy for most evaluated specimens, while excluding bariatric stomach specimens in which microscopic pathology could be missed, given the lack of H pylori screening at our institution.

Prostate Biopsy Processing.

OBJECTIVES: Current protocols for processing multiple prostate biopsy cores per case are uneconomical and cumbersome. Tissue fragmentation and loss compromise cancer diagnosis. We sought to study an alternate method to improve processing and diagnosis of prostate cancer. METHODS: Two sets of sextant biopsy specimens from near-identical locations were obtained ex vivo from 48 prostate specimens. One set was processed in the standard fashion while the other was processed using the BxChip, a proprietary biomimetic matrix that accommodates six cores on a single chip. Parameters including grossing, embedding, sectioning and reading time, length of tissue, and degree of fragmentation were compared. RESULTS: A significant reduction (more than threefold) in preanalytical and analytical time was observed using the multiplex method. Nonlinear fragmentation was absent, in contrast to standard processing. CONCLUSIONS: The BxChip reduced tissue fragmentation and increased efficiency of prostate biopsy diagnosis. It also resulted in overall cost savings and significantly increased tissue length.

Cost Effectiveness of Intraoperative Gross Examination in Colorectal Resections: A Retrospective Review of 200 Consecutive Cases.

CONTEXT.­: Intraoperative pathology consultation is an important tool for many surgical procedures and is deemed appropriate when the pathology result immediately alters surgical management. OBJECTIVE.­: To evaluate the utility of intraoperative gross examinations of colorectal resections and to better understand the associated costs. DESIGN.­: The pathology database of our institution was searched for colorectal resections for primary disease, and those cases were separated into 3 categories: frozen section performed, intraoperative gross examination performed, and no intraoperative consultation. We reviewed 270 cases during a 15-month period. RESULTS.­: Of the 270 cases, 200 (74.1%) had an intraoperative gross examination. In 34 of the 200 cases (17%), additional specimens were taken and, therefore, required operative note review to ascertain whether the additional specimens taken were based on the findings from the intraoperative gross examination. After reviewing the operative notes for those 34 cases, none (0%) were a result of the gross findings reported. The average associated time for intraoperative gross examinations was 27.67 minutes (including transport). The billable costs exceeded $7000 during the study period, and the cost of the pathology assistant's time per case was $22.10. CONCLUSIONS.­: Our study demonstrates that no change in surgical management was a result of gross examination of colorectal resection specimens and that the associated costs were significant. Decreasing unnecessary consultations will directly save the health care system money by eliminating billable services and will also increase the efficiency of the pathology department by reducing the opportunity costs for the time of the pathologist and the pathology staff.

Routine Pathologic Evaluation of Plastic Surgery Specimens: Are We Wasting Time and Money?

BACKGROUND: Recent health care changes have encouraged efforts to decrease costs. In plastic surgery, an area of potential cost savings includes appropriate use of pathologic examination. Specimens are frequently sent because of hospital policy, insurance request, or habit, even when clinically unnecessary. This is an area where evidence-based guidelines are lacking and significant cost-savings can be achieved. METHODS: All specimen submitted for pathologic examination at two hospitals between January and December of 2015 were queried for tissue expanders, breast implants, fat, skin, abdominal pannus, implant capsule, hardware, rib, bone, cartilage, scar, and keloid. Specimens not related to plastic surgery procedures were excluded. Pathologic diagnosis and cost data were obtained. RESULTS: A total of 759 specimens were identified. Of these, 161 were sent with a specific request for gross examination only. There were no clinically significant findings in any of the specimens. There was one incidental finding of a seborrheic keratosis on breast skin. The total amount billed in 2015 was $430,095. CONCLUSIONS: The infrequency of clinically significant pathologic examination results does not support routine pathologic examination of all plastic surgery specimens. Instead, the authors justify select submission only when there is clinical suspicion or medical history that warrants evaluation. By eliminating unnecessary histologic or macroscopic examination, significant cost savings may be achieved.

Utility of Additional Tissue Sections in Surgical Pathology.

BACKGROUND: To avoid diagnostic errors such as missed diagnosis and errors in staging tumors due to inadequate tissue sampling, pathologists submit additional sections (AS). OBJECTIVE: This study assessed frequency, diagnostic yield, distribution, and cost of AS. METHOD: Among 1542 AS cases, we calculated mean AS per case; fraction of AS that altered diagnosis or stage; AS variation by tissue, malignant versus benign lesions, presence or absence of neoadjuvant therapy, mass, margin, lymph nodes, or other source, resident versus pathologist assistant (PA) dissector; and AS cost per case. RESULTS: Overall 9.2 ± 8.8 AS were collected per case. In only 3.8% (58/1542) of cases AS altered diagnosis or stage. Urinary bladder cases provoked the most AS: 19.5 ± 15.1 per case. Significantly more AS came from malignant versus benign lesions (10.8 ± 9.7 vs 7.6 ± 7.5, P = <.0001) and from specimens treated with neoadjuvant therapy versus malignant lesions not so treated (12.3 ± 9.4 vs 10.3 ± 9.8, P = .02). Lymph nodes were sampled more heavily compared with mass, margin, and other sites combined (11.8 ± 11.4 vs 8.9 ± 8.4, P = .003), but in 78.4% (1209/1542) of cases, AS were from mass. Of diagnosis or stage altering AS cases, two thirds (38/58) were from masses, one fifth (11/58) from lymph nodes, a 10th (6/58) from margins, and a 20th (3/58) from other specimen sites. Resident versus pathologist assistant dissection caused no significant AS difference. AS contributed 40% cost per case. CONCLUSIONS: AS per case ranged widely; their diagnostic yield was low; they were highest in urinary bladder specimens, in malignant and particularly neoadjuvant-treated lesions. Although lymph nodes were most heavily sampled, most AS were from masses. Resident dissection did not increase AS and cost of AS was high.

Cost Analysis of Operating an Anatomic Pathology Laboratory in a Middle-Income Country.

Objective: To examine the cost of operating an anatomic pathology laboratory in a teaching hospital in Malaysia. Once the cost is determined, compare it with the costs of operating other laboratories in the same hospital, and operating anatomic pathology laboratories in other countries. Methods: Cost and workload data were obtained from hospital records for 2015. Time allocation of staff between laboratory testing and other activities was determined using assumptions from published workload studies. Results: The laboratory received 20,093 cases for testing in 2015, and total expenditures were US $1.20 million, ie, $61.97 per case. The anatomic pathology laboratory accounted for 5.2% of the laboratory budget at the hospital, compared to 64.3% for the clinical laboratory and 30.5% for the microbiology laboratory. We provide comparisons to a similar laboratory in the United States. Conclusions: Anatomic pathology is more costly than other hospital laboratories due to the labor-intensive work, but is essential, particularly for cancer diagnoses and treatment.

Routine pathologic examination of tonsillectomy specimens: A 10-year experience at a tertiary care children's hospital.

OBJECTIVE: To review histopathologic diagnoses from tonsillectomy specimens and determine whether routine pathologic exam is necessary. METHODS: Pathology reports of patients undergoing tonsillectomy from 2005 to 2014 at our pediatric tertiary care hospital were reviewed. Histopathologic diagnoses were recorded with special attention to identification of malignancy. RESULTS: A total of 8807 paired tonsil specimens were sent to pathology over a 10-year course. Gross analysis was performed on all. Microscopic histopathologic analysis was performed on 612 (6.95%) specimens with all but one demonstrating strictly reactive lymphoid hyperplasia. The single specimen (0.16%) demonstrated follicular hyperplasia with focal necrotizing granulomatous lymphadenitis without organisms identified on special staining. The surgeon requested pathologic diagnosis to rule out lymphoma in 4 of 8087 (0.05%) of the specimens. No malignancies were identified. The approximate charges for gross examination of a paired tonsillectomy specimen and microscopic examination were $136.10 and $294.54, respectively. Over the 10 year period of the study, total charges were estimated at $1,115,340 (gross) and $180,258 (microscopic). DISCUSSION: Microscopic analysis of tonsil specimens is unlikely to identify abnormal pathology that changes patient management. This study suggests that neither gross nor microscopic pathologic examination of tonsillectomy specimens is necessary on a routine basis. Histologic analysis of tonsils should be requested only on a case by case basis when clinical suspicion for malignancy is high. Avoiding routine pathologic exam of tonsils may be cost effective and medically safe.

Current Valuation of Pathology Service.

Health care reform has accelerated as the existing health care system undergoes continuing financial stress. Medicare's new value-based payment system, commonly referred to as MACRA, provides opportunities for physicians to participate in this new system in a variety of ways. However, many of the value-based adjustments are based on existing valuations of services through traditional mechanisms. To achieve appropriate valuation of pathologist's services in the new payment models, it is imperative that we continue to achieve proper valuation of services through the traditional mechanisms.

Sustainable Development of Pathology in Sub-Saharan Africa: An Example From Ghana.

CONTEXT: - Pathology services are poorly developed in Sub-Saharan Africa. Komfo Anokye Teaching Hospital in Kumasi, Ghana, asked for help from the pathology department of the University Hospital of North Norway, Tromsø. OBJECTIVE: - To reestablish surgical pathology and cytology in an African pathology department in which these functions had ceased completely, and to develop the department into a self-supporting unit of good international standard and with the capacity to train new pathologists. DESIGN: - Medical technologists from Kumasi were trained in histotechnology in Norway, they were returned to Kumasi, and they produced histologic slides that were temporarily sent to Norway for diagnosis. Two Ghanaian doctors received pathology training for 4 years in Norway. Mutual visits by pathologists and technologists from the 2 hospitals were arranged for the introduction of immunohistochemistry and cytology. Pathologists from Norway visited Kumasi for 1 month each year during 2007-2010. Microscopes and immunohistochemistry equipment were provided from Norway. Other laboratory equipment and a new building were provided by the Ghanaian hospital. RESULTS: - The Ghanaian hospital had a surgical pathology service from the first project year. At 11 years after the start of the project, the services included autopsy, surgical pathology, cytopathology, frozen sections, and limited use of immunohistochemistry, and the department had 10 residents at different levels of training. CONCLUSIONS: - A Ghanaian pathology department that performed autopsies only was developed into a self-supported department with surgical pathology, cytology, immunohistochemistry, and frozen section service, with an active residency program and the capacity for further development that is independent from assistance abroad.

Changing Dermatopathology Protocols for Processing Small Skin Biopsies: Decreases in Slide Quantity Does Not Affect Patient Care and Allows for Optimal Efficiency.

In dermatopathology, no standard protocol exists for processing small biopsy specimens. In our original protocol, 2 routine initial slides per biopsy were prepared. For 1003 biopsies, we noted how often the second slide helped in diagnosis or eliminated the need for additional deeper sections. After obtaining these data, we switched to processing only 1 initial slide (new protocol) and again evaluated 1003 biopsies. During the original protocol, the second slide never helped to make a diagnosis that was not apparent on the first slide. When deeper sections were ordered (10.4% of cases), they helped in the diagnosis 34.6% of the time. In the new protocol, deeper sections were ordered in 15.9% of cases and helped in the diagnosis 32.7% of the time when ordered. Comparing rates of deeper sections ordered showed no significant difference for benign, inflammatory/reactive, and premalignant/malignant groups (P > 0.1). However, there was a significant increase in deeper sections ordered for melanocytic lesions from 16.9% to 32.3% (P < 0.05). Also, a significantly greater percentage of punch biopsies (31.5% and 42.0% in the respective protocols) required deeper sections than shave biopsies (7.4% and 12.6% in the respective protocols). Switching protocols, the estimated annual cost savings is $2890. The majority of cases at our institution are properly diagnosed using only 1 slide. From our study findings, we conclude that 1 slide preparation for small biopsies is the best practice for our institution and one that does not affect diagnostic accuracy, reduces costs, and helps in effective time management.

A quality initiative of postoperative radiographic imaging performed on mastectomy specimens to reduce histology cost and pathology report turnaround time.

Breast pathology relies on gross dissection for accurate diagnostic work, but challenges can necessitate submission of high tissue volumes resulting in excess labor, laboratory costs, and delays. To address these issues, a quality initiative was created through implementation of the Faxitron PathVision specimen radiography system as part of the breast gross dissection protocol; this report documents its impact on workflow and clinical care. Retrospective data from 459 patients who underwent simple or modified radical mastectomy at our institution between May 2012 and December 2014 were collected. Comparison was made between the mastectomy specimen control group before radiography use (233 patients, 340 breasts) and Faxitron group that underwent postoperative radiography (226 patients, 338 breasts). We observed a statistically significant decrease in mean number of blocks between control and Faxitron groups (47.0 vs 39.7 blocks; P<.0001), for calculated cost savings of US $146 per mastectomy. A statistically significant decrease in pathology report turnaround time was also observed (4.2 vs 3.8days; P=.038). Postoperative mastectomy specimen radiography has increased workflow efficiency and decreased histology costs and pathology report turnaround time. These findings may underestimate actual benefits and highlight the importance of quality improvement projects in anatomical pathology.

Low-cost workflow improvement reduces gastrointestinal block use 17% by altering classic histotechnology testing.

OBJECTIVES: Gastrointestinal (GI) biopsy specimens were previously limited to four per cassette to facilitate established internal technical work practices and histotechnology best practice guidelines. We evaluated the workflow of these biopsy specimens. METHODS: We implemented three specific changes: (1) up to 10 GI biopsy specimens could be placed in each cassette, (2) histotechnologists would no longer orient GI biopsy specimens, and (3) embedding would be in a straight line rather than diagonal. We evaluated the effects of these changes on total block numbers, quality of slides, and perceptions of staff. RESULTS: The mean number of cassettes used was reduced 17% for GI biopsy cases, or an overall decrease of 3% of total blocks processed by our histopathology laboratory. Slide quality was unchanged. Staff reported increased job satisfaction. CONCLUSIONS: This simple, low-cost, low-effort process change yielded immediate and significant time savings for grossing and histology staff, increased job satisfaction, and challenges conventional histotechnology teaching.

Whole slide imaging: uses and limitations for surgical pathology and teaching.

Advances in computer and software technology and in the quality of images produced by digital cameras together with development of robotic devices that can take glass histology slides from a cassette holding many slides and place them in a conventional microscope for electronic scanning have facilitated the development of whole slide imaging (WSI) systems during the past decade. Anatomic pathologists now have opportunities to test the utility of WSI systems for diagnostic, teaching and research purposes and to determine their limitations. Uses include rendering primary diagnoses from scanned hematoxylin and eosin stained tissues on slides, reviewing frozen section or routine slides from remote locations for interpretation or consultation. Also, WSI can replace physical storage of glass slides with digital images, storing images of slides from outside institutions, presenting slides at clinical or research conferences, teaching residents and medical students, and storing fluorescence images without fading or quenching of the fluorescence signal. Limitations include the high costs of the scanners, maintenance contracts and IT support, storage of digital files and pathologists' lack of familiarity with the technology. Costs are falling as more devices and systems are sold and cloud storage costs drop. Pathologist familiarity with the technology will grow as more institutions purchase WSI systems. The technology holds great promise for the future of anatomic pathology.

Current projects in Pre-analytics: where to go?

The current clinical practice of tissue handling and sample preparation is multifaceted and lacks strict standardisation: this scenario leads to significant variability in the quality of clinical samples. Poor tissue preservation has a detrimental effect thus leading to morphological artefacts, hampering the reproducibility of immunocytochemical and molecular diagnostic results (protein expression, DNA gene mutations, RNA gene expression) and affecting the research outcomes with irreproducible gene expression and post-transcriptional data. Altogether, this limits the opportunity to share and pool national databases into European common databases. At the European level, standardization of pre-analytical steps is just at the beginning and issues regarding bio-specimen collection and management are still debated. A joint (public-private) project entitled on standardization of tissue handling in pre-analytical procedures has been recently funded in Italy with the aim of proposing novel approaches to the neglected issue of pre-analytical procedures. In this chapter, we will show how investing in pre-analytics may impact both public health problems and practical innovation in solid tumour processing.

Development of an intraoperative pathology consultation service at a free-standing ambulatory surgical center: clinical and economic impact for patients undergoing breast cancer surgery.

BACKGROUND: Second surgeries represent a significant detriment to breast cancer patients. We examined the impact an intraoperative pathology consultation service had on multiple facets of breast cancer surgery. METHODS: We compared the 8 months before the establishment of a pathology laboratory, when intraoperative pathology consultation was not available, with the 8 months subsequent, when it was performed routinely. RESULTS: The average number of surgeries per patient decreased from 1.5 to 1.23, and the number of patients requiring one surgery increased from 59% to 80%. Re-excisions decreased from 26% to 9%. Frozen section allowed 93% of node-positive patients to avoid a second surgery for axillary lymph node dissection. A cost analysis showed savings between $400 and $600 per breast cancer patient, even when accounting for fewer axillary lymph node dissections based on the American College of Surgeons Oncology Group Z0011 data. CONCLUSIONS: Incorporation of routine intraoperative margin/sentinel lymph node assessment at an outpatient breast surgery center is feasible, and results in significant clinical benefit to the patient. Use of frozen section decreased both the time and cost required to treat patients.

Breast capsulectomy specimens and their clinical implications.

BACKGROUND: Plastic surgeons routinely submit breast capsulectomy surgical specimens for pathologic evaluation. However, clinically significant findings are rarely identified. In an effort to reduce health care costs and the unnecessary use of hospital resources, this study reviews the efficacy of submitting breast capsulectomy specimens for pathologic examination. METHODS: All patients from The Methodist Hospital in Houston, Texas, during the years 2000 to 2008 who underwent breast capsulectomy were selected for by Current Procedural Terminology codes 19370 and 19371 (open periprosthetic capsulotomy and periprosthetic capsulectomy of the breast, respectively). A total of 264 patients qualified for the study, and their pathology reports were reviewed. RESULTS: The pathology reports of 434 capsulectomy specimens in 264 patients revealed benign capsules in 206 patients (78.0 percent). Additional findings, including inflammation, calcification, granuloma, and necrosis, were identified in an additional 57 patients (21.6 percent). One patient (0.4 percent) had carcinoma identified within a breast capsule. This was a patient known preoperatively to have recurrent invasive ductal carcinoma that extended into the surrounding capsule. Therefore, none of the 264 capsulectomy specimens revealed new neoplasms, occult disease, or other clinically significant findings that changed the patient's postoperative treatment. CONCLUSIONS: No clinically significant findings were identified in this review of breast capsulectomy specimens in 264 patients. However, the cost for such pathologic examinations was substantial. In an effort to reduce health costs and the unnecessary use of hospital resources, breast capsulectomy specimens may not necessarily need to be routinely submitted for surgical pathologic evaluation.

Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory.

CONTEXT: The need for higher efficiency, maximum quality, and faster turnaround time is a continuous focus for anatomic pathology laboratories and drives changes in work scheduling, instrumentation, and management control systems. OBJECTIVE: To determine the costs of generating routine, special, and immunohistochemical microscopic slides in a large, academic anatomic pathology laboratory using a top-down approach. DESIGN: The Pathology Economic Model Tool was used to analyze workflow processes at The Nebraska Medical Center's anatomic pathology laboratory. Data from the analysis were used to generate complete cost estimates, which included not only materials, consumables, and instrumentation but also specific labor and overhead components for each of the laboratory's subareas. The cost data generated by the Pathology Economic Model Tool were compared with the cost estimates generated using relative value units. RESULTS: Despite the use of automated systems for different processes, the workflow in the laboratory was found to be relatively labor intensive. The effect of labor and overhead on per-slide costs was significantly underestimated by traditional relative-value unit calculations when compared with the Pathology Economic Model Tool. Specific workflow defects with significant contributions to the cost per slide were identified. CONCLUSIONS: The cost of providing routine, special, and immunohistochemical slides may be significantly underestimated by traditional methods that rely on relative value units. Furthermore, a comprehensive analysis may identify specific workflow processes requiring improvement.