A retrospective multi-site examination of chronic kidney disease using longitudinal laboratory results and metadata to identify clinical and financial risk.

Background: A retrospective observational study was conducted at 3 health care organizations to identify clinical gaps in care for patients with stage 3 or 4 chronic kidney disease (CKD), and financial opportunity from U.S. risk adjustment payment systems.

The Application and Pitfalls of Immunohistochemical Markers in Challenging Diagnosis of Genitourinary Pathology.

Context.—: The morphologic features of different entities in genitourinary pathology overlap, presenting a diagnostic challenge, especially when diagnostic materials are limited. Immunohistochemical markers are valuable when morphologic features alone are insufficient for definitive diagnosis.

The Role of the Pathologist in Population Health.

Context.—: As part of its value-based care initiative, the College of American Pathologists has pursued research to better understand the role pathologists can have in population health.

Objectives.

Improving American Healthcare Through "Clinical Lab 2.0": A Project Santa Fe Report.

Project Santa Fe was established both to provide thought leadership and to help develop the evidence base for the valuation of clinical laboratory services in the next era of American healthcare. The participants in Project Santa Fe represent major regional health systems that can operationalize laboratory-driven innovations and test their valuation in diverse regional marketplaces in the United States. We provide recommendations from the inaugural March 2016 meeting of Project Santa Fe.

Pathologists as stewards of laboratory information.

Just as electronic health records are transforming the practice of medicine and health care information management, practicing in the era of the electronic health record offers opportunities, if not imperatives, for pathologists to take on new and "transformative" professional and leadership roles for the organizations they serve. Experience indicates that clinicians will perceive pathologists and laboratories as responsible for all aspects of laboratory testing and information management, including order entry and results reporting, even though such functions may fall beyond the control of the laboratory. As described and expanded upon in the previous 4 articles of this series, the use of electronic health records dictates changes in how clinicians interact with laboratory information.

Accreditation and regulatory implications of electronic health records for laboratory reporting.

The Clinical Laboratory Improvement Amendments of 1988 include strict regulations for reporting content, and it falls on the named director to ensure that this content is available to the caregiver. With the electronic health record serving as the conduit to the end user of the laboratory data, the laboratory generally, and the director specifically, must verify accurate transmission of these content components. An understanding of regulatory and accreditation requirements is essential both to allow the proper discharge of these mandated responsibilities and to enforce the role and authority that the pathologist must have to ensure that these requirements are satisfied by the reporting system.

Management of laboratory data and information exchange in the electronic health record.

In the era of the electronic health record, the success of laboratories and pathologists will depend on effective presentation and management of laboratory information, including test orders and results, and effective exchange of data between the laboratory information system and the electronic health record. In this third paper of a series that explores empowerment of pathology in the era of the electronic health record, we review key elements of managing laboratory information within the electronic health record and examine functional issues pertinent to pathologists and laboratories in the exchange of laboratory information between electronic health records and both anatomic and clinical pathology laboratory information systems. Issues with electronic order-entry and results-reporting interfaces are described, and considerations for setting up these interfaces are detailed in tables.

Stand-alone laboratory information systems versus laboratory modules incorporated in the electronic health record.

The increasing availability of laboratory information management modules within enterprise electronic health record solutions has resulted in some institutional administrators deciding which laboratory information system will be used to manage workflow within the laboratory, often with minimal input from the pathologists. This article aims to educate pathologists on many of the issues and implications this change may have on laboratory operations, positioning them to better evaluate and represent the needs of the laboratory during this decision-making process. The experiences of the authors, many of their colleagues, and published observations relevant to this debate are summarized.

Pathologists' place in the electronic health record landscape.

With growth spurred by recent federal efforts, electronic health records (EHRs) are transforming the practice of medicine and have important implications for pathologists, their laboratories, and the patients they serve. Beyond new EHR-related regulatory requirements, EHRs fundamentally alter the way clinicians interact with laboratory information, including test order entry and result reviewing. This article is the first in a series of 5 related articles whose goal is to provide a "framework" for empowering pathologists to adapt to, and to succeed in, the era of expanding EHR use.

The application of immunohistochemical biomarkers in urologic surgical pathology.

Context: Tumors of the genitourinary tract can be diagnostically challenging, particularly in core biopsies and cystoscopic biopsies with limited material. Immunohistochemistry is a valuable tool to use when morphology alone is insufficient for diagnosis.

Objectives: To review tumors and benign lesions of the kidney, urinary bladder, prostate gland, testis, and paratesticular structures with an emphasis on difficult differential diagnoses, as well as staining patterns in normal tissue.

Fresh frozen plasma as a source of cholesterol for newborn with Smith-Lemli-Opitz syndrome associated with defective cholesterol synthesis.

The Smith-Lemli-Opitz Syndrome (SLOS) is an autosomal recessive condition that is characterized by a mutation in the DHCR7 encoding the 7-dehydrocholesterol-Δ7 reductase, the enzyme that catalyzes the last step in cholesterol biosynthesis. The syndrome occurs in 1:20,000 newborns with an estimated gene carrier frequency in US Caucasian population of 1 to 2%. The severe form of SLOS in newborns leads to multiple malformations and mental retardation.

Immunohistochemical evaluation of ERG expression in various benign and malignant tissues.

The transmembrane protease, serine 2-E twenty-six related gene (TMPRSS2-ERG) fusion leading to ERG overexpression, was detected in approximately 50% of prostate cancers (ranging from 35-70%). However, the published data on ERG expression in tumors from other organs and normal tissues were limited. In this study, we investigated the expression of ERG in TMA sections of various normal tissues (N=452) and carcinomas (N=1,129) from various organs, including 90 cases of low to intermediate-grade (L-MG) prostatic adenocarcinomas and 36 cases of high-grade (HG) prostatic adenocarcinomas, using a single immunostaining system (Dako).

Immunohistochemical evaluation of GATA3 expression in tumors and normal tissues: a useful immunomarker for breast and urothelial carcinomas.

GATA3 expression has been reported in urothelial and breast carcinomas; however, the published data on GATA3 expression in tumors from other organs are limited. Immunohistochemical evaluation of GATA3 expression in 1,110 carcinomas and 310 cases of normal tissue using tissue microarray sections, 48 breast and bladder biopsy specimens, and 53 breast fine-needle aspiration biopsy specimens was performed. Sixty-two of 72 urothelial carcinomas (86%) and 138 of 147 breast carcinomas (94%) tested positive for GATA3.

Expression of von Hippel-Lindau gene product (pVHL) and S100P in cystic neoplasms of the pancreas--with an implication for their roles in tumorigenesis.

Our recent study demonstrated the inverse correlation of expression of S100P and von Hippel-Lindau gene product (pVHL) in pancreatic intraepithelial neoplasia (PanIN) and pancreatic ductal adenocarcinoma (PDA). This study investigates whether there is a correlation of expression of these two markers in common cystic neoplasms of the pancreas. Immunohistochemical stains for S100P and pVHL were performed on 97 cystic neoplasms of the pancreas, including 23 mucinous cystic neoplasms (MCNs), 39 intraductal papillary mucinous neoplasms (IPMNs), 12 solid pseudopapillary tumors (SPTs), and 23 serous microcystic adenomas (SMAs).

Informatics tools for quality in anatomic pathology.

This article reviews three informatics tools developed as part of an overall quality program in an anatomic pathology laboratory. These tools include a tracking monitor for analyzing the entire testing process through pre-analytic, analytic, and postanalytic phases; the use of digital imaging in quality control of immunohistochemistry in the analytic phase; and a results-reporting monitor for flow of postanalytic data to patient data repositories.

Histologic evaluation of the testicular remnant associated with the vanishing testes syndrome: is surgical management necessary?

Objectives: There is controversy surrounding the optimal management of the testicular remnant associated with the vanishing testes syndrome. Some urologists advocate the need for surgical exploration, whereas others believe this is unnecessary. These differing opinions are based on the variable reports of viable germ cell elements found within the testicular remnants.

Usefulness of S100P in diagnosis of adenocarcinoma of pancreas on fine-needle aspiration biopsy specimens.

Even though the cytologic criteria for pancreatic ductal adenocarcinoma (PDA) on fine-needle aspiration biopsy (FNAB) specimens have been well defined, a diagnostic challenge is still present. We immunohistochemically evaluated the diagnostic value of S100P on cell-block and/or smear preparations in 58 cases of FNAB specimens of the pancreas. The 58 cases were divided into 4 groups: 1, 32 cases of PDA; 2, 6 cases with an atypical or "suspicious" diagnosis; 3, 14 cases of benign or reactive ductal epithelium; and 4, 6 cases of endocrine tumor.

Evaluation of p16INK4a, minichromosome maintenance protein 2, DNA topoisomerase IIalpha, ProEX C, and p16INK4a/ProEX C in cervical squamous intraepithelial lesions.

p16INK4a has been shown to be overexpressed in nearly all high-grade squamous intraepithelial lesions (HSILs). Other cell-cycle regulators, such as minichromosome maintenance protein 2 (MCM2), DNA topoisomerase IIalpha (TOP IIA), and ProE(X) C (a cocktail of MCM2 and TOP IIA), have also demonstrated some value in identifying squamous intraepithelial lesions. Data on direct comparison of those cell regulatory proteins in the detection of squamous intraepithelial lesions, with a focus on low-grade squamous intraepithelial lesions (LSILs), are limited.

Immunohistochemical detection of p16INK4a in liquid-based cytology specimens on cell block sections.

Background: Colposcopy biopsy procedure is a standard recommendation for atypical squamous cell cannot exclude high-grade lesion (ASC-H) in abnormal Papanicolaou smears. p16 (p16INK4a), a cell cycle regulator, has been shown to be overexpressed in squamous dysplasia. To further improve the diagnostic accuracy of the ASC-H Papanicolaou smear and to reduce unnecessary procedures, the authors evaluated the utility of immunodetection of p16 in liquid-based cytology specimens on cell blocks.

A novel cross-disciplinary multi-institute approach to translational cancer research: lessons learned from Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC).

Background: The Pennsylvania Cancer Alliance Bioinformatics Consortium (PCABC, http://www.pcabc.upmc.